Fifteen Years of Experience in Treating 2177 Episodes

of Foot and Leg Lesions with the Circulator Boot

 

Results of Treatments with the Circulator Boot

 

Richard S. Dillon, M.D.

 

Bryn Mawr Hospital

Department of Medicine

Section  of Endocrinology

 

Jefferson Medical School

Ó 1997 Westminister Publications, Inc. 708 Glen Cove Avenue, Glen Head, N.Y. 11545, U.S.A.

 

 

 

                  

                  

 

Abstract

 

Objective: To determine the clinical effectiveness of the end-diastolic pneumatic compression boot and of local antibiotics in treating limb lesions associated with diabetes and peripheral arterial, venous and neuropathic disease.

Research  Design and Methods: Office and hospital data were kept over 15 years on 2177 episodes of leg problems classified by the Wagner method for 1514 legs of 1035 patients largely referred because of failure of standard therapies. The fate of the untreated legs served  as a controls when possible.

Results:  Healing  or improvement of treated legs was seen above that in the literature in all Wagner categories and was significant  (P<0.001) compared to the “control” leg which deteriorated in 38.7% of patients. Significant risk factors against a successful outcome included smoking, inability to walk, increased home distance from the boot center, loss to treatment, hemodialysis, a Wagner 4-5 classification, inoperable iliac occlusions,  vascular procedures before or after referral for boot therapy and an aggressive vascular surgeon. Neuropathy allowed successful treatment of lesions nondiabetic patients could not tolerate. Relapse was significantly more frequent in ASO patients with diabetes than without diabetes and in patients with neuropathy than those with ASO.  Diabetes did not affect the relapse rate in stasis disease. The overall percentage of legs having major amputations was low: 2.46% for diabetic legs at the initial treatment episode, 1.6% at the time of a relapse and 4.14% after seeking treatment elsewhere. For nondiabetic patients, the respective risks were similar:  2.0%, 1.18% and 2.88%.

           

 

 

Introduction

                Limb loss in diabetic patients has continued to be a problem in spite of the development of new antibiotics, new methods of limb vascularization and new emphasis on preventive measures (1,2,3,4,5). Approximately one third of limbs compromised enough to be referred to a tertiary care program or compromised enough to earn a Wagner 3-4 classification are amputated (6,7,8).  The contralateral limb is also at great risk with the risk of amputation exceeding 50% within the first four years after the loss of the first leg (9). In one study, contralateral amputation was required in one-third of patients after a mean of eight months(10). The Circulator Boot System is a patented system developed to treat these difficult legs.  Directions for the use of the boot equipment are detailed in the company manual and in the section on “Method of Treatment” elsewhere in this supplement. The “boot” is an end-diastolic pneumatic compression boot system designed to improve the arterial circulation in the leg(11) and has been shown to improve significantly most tests of peripheral arterial perfusion(12). Resistant venous lesions also respond to therapy(13).  It is difficult to design and hold together a large controlled prospective study,  especially for the feet of elderly patients with arteriosclerosis and neuropathy associated with diabetes,  slow healing, frequent relapses, decreased allowed time for hospital care, and transportation problems for long term outpatient care.  Indeed, there are no such studies to justify the revascularization  procedures, for example,  practiced in our hospitals today.  In an attempt to make each patient his/her own control, I have published  two reports on consecutive patients who had been offered the option of leg amputation, standard therapies having failed, or boot therapy.  In the first study, 33 of 34 legs were spared major amputations (14); and in the second study, of 35 patients with 42 episodes of osteomyelitis, all were spared major amputation(15). The technique and advantages of the combined treatments: Circulator Boot treatments, local antibiotic injections and antibiotic-containing multielectrolyte solutions have been described in detail(16). The importance of the multielectrolyte solution in wound healing has been reported separately(17). The multielectrolyte solution used in our patients was Sea Soaks-TM  of Circulator Boot Corp., an isotonic sterile filtrate of sea water. This report summarizes 15 years of experience in treating 2177 episodes in 1035 patients, who were largely referred because of failure of previous therapy.

 

 

Methods

Treatment Setting: Patients were treated in the Bryn Mawr Hospital ( a prosperous community teaching hospital  with a strong vascular surgery service), the private outpatient  office of the author or a local nursing home boot facility. Because of  pressures from our utilization committee and insurance companies, inpatient care was limited to those who were in the hospital at the time of  their initial referral, to those with general medical problems (heart, kidney, etc.) that warranted hospitalization independent of their leg problems, and to those with sepsis.  Inpatients with leg problems so advanced  to make outpatient follow-up difficult were transferred to the nursing home boot facility where their progress was reviewed weekly by the doctor who provided typed orders at  weekly intervals for the lay boot technicians. Otherwise, all lesions from a Wagner 1 to a Wagner 5 were treated in an outpatient setting.

Origin of Patients: The origin of the patients was tabulated to be related to outcome. A particular source was listed for the patient if that source was listed by the patient as the referring physician or, in the absence of such a note, if the physician was the person making the initial contact with our office. Patients were listed as coming from the practice of the author if they were either followed there for years (relatively few) or if they had been followed for several months and treated conservatively  before boot therapy was added to their program.

Age and Sex of Legs:  Overall, the number of legs treated (average +/- standard deviation for age at presentation) were 356 female diabetic legs  (68.16+/-14.36 years), 295 female nondiabetic legs (72.71+/-12.86 years), 551 male diabetic legs (66.43+/-10.86 years) and 293 male nondiabetic legs (68.79+/-13.00 years).

Accumulated Historical and Photographic Data: At the time of their initial visit, photographs were taken of any foot lesions present and the foot was classified according to the Wagner classification: “0” if skin intact and only bony deformities; “1” if a localized superficial ulceration and/or cellulitis; “2” if a deep ulcer to tendon, bone, ligament or joint; “3” if a deep abscess or osteomyelitis; “4” if gangrene of toe(s) or forefoot; and “5” if gangrene of the whole foot (18). If a foot appeared blue and cold on presentation but warmed with a single treatment, it was considered a “0”. Suggested standards of a Vascular Surgery Society for reports dealing with lower extremity ischemia were also noted (19).  Their categories 0 to 4 varied from no symptoms, mild claudication, moderate claudication, moderate claudication to rest pain. Their category 5 (minor tissue loss) is similar to Wagner 2 and 4 while their category  6 (major tissue loss extending above the TM level) is similar to Wagner 5. Since 1990, the questionnaire reported by Regensteiner et al was used in following walking capacity (20). A record was begun for each leg. Name of referring source, patient name and home address, leg involved, patient date of birth, date of presentation for each leg for boot treatment, date of onset of the current chief complaint, estimate of  the maximum walking distance in feet, Wagner classification, smoking history, the presence and type of diabetes, history of previous TIA or stroke, New York Heart classification, number and kind of previous vascular procedures and previous amputations were noted. Subsequently, the effect of our initial treatments were noted along with later relapses (up to 3 relapses allowed on the computer columns), the results of their treatments and the results of treatments obtained elsewhere if the patient left our care. A few patients had more than three relapses, which, unless they resulted in a leg amputation, are not included. An attempt was made to reach all patients or their families over the three months prior to the tabulation of  the data for this manuscript. Their date of death and any  major amputation is included in our data whether associated with our treatment or that performed elsewhere.

              Distribution of Treatments in Three Major Disease Categories: Arteriosclerosis Obliterans (ASO), Neuropathy and Stasis According to Physical and Vascular Laboratory Findings:  The status of peripheral pulses was noted and appropriate noninvasive vascular testing was accomplished unless provided from recent outside records. Our vascular tests might include Doppler mapping if an arteriogram was not available and arterial reconstruction was an option. Routine pulse volume measurements, segmental blood pressures, the ankle/arm blood pressure ratio (ABI), photoelectricplethsmyography (PPG) tracings of the toes or ulcer edges and, in the last few years, transcutaneous PO2 and PCO2  levels were recorded as indicated. The presence or absence of deep tendon reflexes and the sensations of light touch, position and vibration were noted. The capacity to sense the standard 5.10 and 6.05 fibers and two-point discrimination (the ability to correctly identify the pressure of one or two sticks pressing the skin at various distances) were noted. Standard venous testing was accomplished if the possibility of deep venous thrombi (the only absolute contraindication to boot therapy) or if the diagnosis of stasis disease was considered. Then venous outflow studies, Doppler flow curves, venous reflux studies and, on rare occasions, more expensive venous Duplex scans were accomplished. Patients with palpable pedal pulses or biphasic Doppler waveforms in the foot and abnormalities in nerve function were listed as having a neuropathic basis for their lesions (e.g. ulcer or osteomyelitis). Those patients with low monophasic Doppler waveforms of the tibial vessels at the ankle, absent or low toe PPG’s, absent or faint Doppler sounds in the foot, transcutaneous PO2 values in the foot under 30 mm Hg, or a lack of continuous runoff into the foot on their arteriograms were listed as having ASO. Those patients with insensate feet and the above vascular abnormalities were listed as having combined ASO-neuropathy as the basis of  their lesions. Perhaps, because of the fact that the Circulator Boot was designed to treat arterial problems, patients with ASO were predominantly referred for treatment.

              Control Data from the “Other Leg”: Those patients presenting with symptoms limited to one leg provided “control data”. While baseline vascular studies commonly pointed to bilateral disease, insurance carriers commonly only pay for treatment of symptomatic disease. The asymptomatic leg was followed as a “control” and was treated only if symptomatic disease (e.g. ulcer, rest pain etc.) developed.

              Method of Result Classification: Patients who were cured or healed of their rest pain, claudication,  ulcer or osteomyelitis were listed as “healed”. Those whose pain was rendered tolerable, walking distance significantly improved or lesion clearly improved prior to death or loss-to-treatment were listed as “improved”.  Those who, after having been evaluated and started on treatment, left our care for any reason (advice of another physician, excessive travel distance, lack of transportation, slow progress, persistent pain or whatever)  were listed as lost-to-treatment, “LTT”. Those whose claudication improved to a lesser degree and leveled to a point where the patient was satisfied, although not entirely pleased, or whose black toe mummified and then changed little thus allowing normal life and modest walking were listed as “stable”. An attempt to amputate and heal such stabilized mummified toes was not made if vascular tests suggested nonhealing of the amputation. It may be noted that this group usually had improved one clinical category and might also have been labeled “improved” using the reporting criteria of the Ad Hoc Committee of the Society for Vascular Surgery (19).  Certain patients were treated for long periods of time in an unsatisfactory state but had few alternatives; they were listed as “chronic”. Those patients who came haphazardly for treatment and whose records were not clear were listed as “blank”. The other categories (“no help”, “slightly worse”, “AKA”, “BKA”, “?Benefit” and “Fails”) are self-explanatory.

              Author’s Recommended Criteria for Leg Amputation: Patients were encouraged to have leg amputations if they met one of three categories: (1) they asked to have their leg removed because of severe and persistent pain unresponsive to all of our therapies; (2) they had a spreading infection that was life threatening; (3) they had a foot so badly damaged that reasonable function was unlikely even if they did heal. No patient lost  leg  or life from spreading infection. Pain was the primary reason for amputation. Other physicians in attendance commonly recommended amputation on other criteria.

 

Results

Control Leg: Overall, treatment was initially begun on one leg in 671 patients; the other leg, if present, required no treatment in 411 patients and developed problems requiring treatment in 260, Table I. Thus,

 

Table I

The Fate of the Other Leg as Control Data

                                              Initial Treatments                                                      Control Legs

                                   ____________________________________________________________________________

                                        1-Leg Only         Both Legs                   Initial           Remain Intact          Breakdown

 

Males, All                               207                     268                            348                     198*                  150(43.1%)          

Females, All                            221                     394                            323                    213*                 110(34.1%)

    Total, all                              429                     962                            671                    411                   260(38.7%)

 

Males, ASO                            138                     376                            239                    129*     110(46.0%)

Females, ASO                         145                     218                            205                      137*                     68(33.1%)

    Total, ASO                         283                     594                            444                      266                     178(40.0%)        

 

Males, Neur                            37                       44                               93                        37                       56(60.2%)

Females, Neur                         29                       18                               47                        29                       18(38.3%)

    Total, Neur                         66                       62                             140                        66                       74(52.9%)

 

Males, Sts                               17                       42                                25                       17                         8(32.0%)

Females, Sts                            37                       40                                51                       37                       14(27.4%)

    Total, StsT                           54                       82                                76                       54                     22(28.9%)

*Not including previous AKAs or BKAs (male 9, female 8).     TIncludes 21 diabetic legs.

AKA = above knee amputation,  BKA = below knee amputation,  ASO = arteriosclerosis obliterans,

Neur = neuropathy,  Sts = stasis disease.

 

 

 of 671 “control legs”, disease progressed enough to require treatment in 260 or 38.7%. Broken down into disease category,  progression of the “control” leg was seen in 40% of ASO cases, 52.9% of neuropathy cases and 28.9% of stasis cases. It was expected that the fate of the presenting leg would be related to the balance of the natural progression of disease (as seen in our “controls”) and the effectiveness of the therapeutic program. If the latter had only a “placebo effect”, our treated legs might be expected to deteriorate in 28.9-52% of cases or more in view of the established and chronically progressive nature of the lesions referred for treatment. As spontaneous improvement in the “control” legs was not seen, the status of the “control” legs not deteriorating might be considered “stable” or “chronic” for 48-71.1% of legs. Against these rates of deterioration and stable-to-chronic states, Chi square determinations in the tables that follow are extremely high (e.g. 1188.8 for the initial results in TableV) and the success of our treatments is highly significant in all disease classes (P<0.001).

                The Wagner class in the presenting leg was in general a guide as to the kind of problem expected  in the good of “control” leg. Thus, among 89 men with a Wagner “0” classification in the bad leg, the “control” leg also became a Wagner “0” in 71 while 4 each developed problems in the Wagner “1”, “2” and “4” classes and 1 each developed lesions in the Wagner “3” and “5” classes. Again, among 49 men with an initial Wagner “4” classification in the bad leg, the “control” leg developed problems in the Wagner “0” class in 7 legs,  in the Wagner “1” class in 1 leg, in the Wagner “2” in 2 legs, in the Wagner “3” in 1 leg, in the Wagner “4” in 25 legs, in the Wagner “5” in 5 legs and in the unclassified category in 8 legs.    

Effect of Source of Patients: The flow of patients to our program is summarized in Figure 1. The largest single source of referrals was satisfied patients and their families. The number of legs from each source and the number of resulting major amputations associated with that source are also given in Figure 1. Overall, 8.36% of legs from all sources were eventually amputated. Significant differences above this average were vascular surgeons 19.1% (P<0.001) and general surgeons 22.7% (P<0.001 but a small sample).

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Duration of Chief Complaint at Time of Presentation for Boot Therapy:  In Table II, the duration of the previous therapies is shown for each Wagner classification for the 1136 legs for which the data was available. Overall, 7.4% of legs presented within the first week of their illness; 64.9% had their problems more than two months and 26.7% had them a year or more. In the most numerous class, Wagner “0”, 33.5%  had their problems two or more years.

Table II

Duration of Chief  Complaint

at Time of Presentation for Boot Therapy

Wagner              0              1              2              3              4              5   

# Patients         394            213           159              95            212            63

<= 7 days       5.58%        9.39%        4.40%        8.42%       8.49%      14.29%          

8-30 days      11.68%      18.30%      19.50%      12.63%     20.75%      25.40% 

31-60 days      5.33%      14.55%      15.09%      10.53%     16.98%        7.94%

2-6 mos          17.77%      29.58%      23.27%      32.63%     28.30%      30.16%

6-12 mos        13.96%      11.74%      16.98%      13.68%     12.74%        9.52%

1-2 yrs            12.18%        9.39%       8.18%      10.53%       4.25%        4.76%

> 2 yrs            33.50%        7.04%      12.58%     11.58%       8.49%        7.94%

 

               

Table III

Early Results for Legs Started on boot within 14 Days

Result:   Healed  Improved   Stable     LTT   No Change   Blank      AKA     BKA   

Males          63             34              6              2                1                1              2*           0

Females      33             27              2              3                 -                3              4e            1**

     *  Sudden occlusion of bilateral aortofemoral bypasses

     ** Consulted but decides against boot therapy and never treated.

     e One patient with Wagner 5 foot after 3 vascular procedures; two renal dialysis patients, one with a

        Wagner 2 and the other a Wagner 4 foot; one patient with rheumatoid vasculitis and an infected 

        prosthesis.

 

The early effect of treatment in patients referred within fourteen days of the onset of their problem are shown in Table III. Two men, who had AKA’s, were poor candidates for boot therapy in that they had no arterial inflow at the groin. Two females with advanced arteriosclerosis obliterans had  AKA’s having boot treatments but 2 to 3 days a week while receiving dialysis on other days. Overall, the group did well while in our care. Nine patients had late major amputations: four females under the care of their referring physicians elsewhere and one female after a second relapse; three males under the care of physicians in other institutions and one male, after a fall and broken leg, in the care of his lawyer. Eventually, 16 of the 182 patients (8.79%) came to major amputations, a rate similar to the overall rate noted above.

Number of Legs Treated and Relapsing: Of 1038 patients, 609 had two legs treated (1218 legs) and 429 had one leg treated for a total of 1647 treated legs (Figure 2). Relapses occurred in 356 (21.6%). A second relapse occurred in 121 legs (7.3%). A third relapse occurred in 54 legs (3.3%). The sum of the initial treatments and relapses constitute the 2177 episodes described in this report. In Table IV,  the legs are classified when possible according to their predominant pathology and the percentages of legs having one, two or three relapses are shown. Compared to nondiabetic patients, both diabetic males and females with ASO were more likely to relapse (P<0.001). Male, but not female, patients with diabetic neuropathy were more likely to have an initial relapse than patients with ASO (P<0.05). If relapse did occur, both male and female patients with diabetic neuropathy were more likely to relapse a second time compared to patients with ASO (P<0.001).  Relapse was common in patients with stasis disease but not more so in those with diabetes (P<0.3). Most patients did well and did not relapse.

 

 

Table IV

Distribution of Treatments and Relapse Rates

Among Patients with ASO, Neuropathy and Stasis Disease

 Diabetes

    Sex

 Disease

 Number

    % 1st

    % 2nd

    % 3rd

   % Fate

   Status 

    M/F

   Type

  1st Rx

   Relapse

    Relapse

    Relapse

Elsewhere

    DM+

      M

   ASO

     400

  28.3*a

      9.75b

      5.0

    9.25

 

 

   Neur

     135

   38.5a

    15.6d

      5.2

    2.96

 

 

   Sts

       19

   42.1

    36.8

     10.5

  10.5

    DM+       

     F

   ASO

     256

   33.2**

    11.3c

       5.5

    0.78

 

 

   Neur

      64

   31.3

    18.8e

     10.9

    4.69

 

 

   Sts

      23

   34.8

      8.7

        0

   4.35

   DM-

    M

   ASO

    220

   11.8*

      3.6

        0

   8.18

 

 

   Sts

     44

   29.5

      6.8

       4.5

   4.54

   DM-

    F

   ASO

   180

   15.6**

      3.3

       1.6

   6.67

 

 

  Sts

     69

   27.5

    13.0

       8.7

   2.90

 

 

 

 

 

 

 

 

Chi Square for 1st Relapse: * P<0.001  ** P<0.001   a P<0.05

Chi Square for 2nd Relapse: b+c vs d+e P<0.001

 

 

Overall Initial Results among Patients Stratified by the Wagner Method: An overall summary giving the numbers of legs in each Wagner class and initial results of treatment by percentages for sex and diabetes state is given in Table 5. It is to be appreciated that it takes a patient and possibly hopeful observer to arrive at such excellent results. Blood flow is returned to the leg slowly by boot therapy; the blood must reach the ankle before it reaches the midfoot and the midfoot before it reaches the toes. In a leg at risk of amputation, toe lesions may worsen initially only to heal or autoamputate later as the leg is salvaged; such a leg is listed here as “healed”.  Leg salvage and maintenance of maximum function and independence were the goals of therapy. Autoamputations of gangrenous toes and eschar over bunions, for example, were not tabulated.

 

 

 

Table 5

Numbers of Legs and Percentage of Initial

 Wagner

    Sex

Diabetes

  Number

  Healed

Improved

  Stable

  Chronic

       0

      M

     N

    139

   2.9%

  72.7%

    6.5%

     0.7%

       0

      F

     N

    134

   3.7%

  78.4%

    2.2%

     0.0%

       0               

      M

     Y

    176

   1.7%

  81.8%

    6.8%

     0.0%

       0

      F

     Y

    116

   9.5%

  84.5%

    0.9%

     0.0%

 

 

 

 

 

 

 

 

      1

     M

     N

      47

 72.3%

  19.1%

    4.3%

     0.0%

      1

     F

     N

      75

 69.3%

  20.0%

    0.0%

     0.0%

      1

     M

     Y

      88

 88.6%

    4.5%

    2.3%

     0.0%

      1

     F

     Y

      62

 62.9%

  19.4%

    0.0%

     0.0%

 

 

 

 

 

 

 

 

      2

     M

     N

      37

 37.8%

  27.0%

  10.8%

     0.0%

      2

     F

     N

      32

 65.6%

  15.6%

    3.1%

     0.0%

      2

     M

     Y

      75

 69.3%

  18.7%

    2.7%

     0.0%

      2

     F

     Y

      58

 62.1%

  20.7%

    8.6%

     0.0%

 

 

 

 

 

 

 

 

      3

     M

    N

      18

 61.1%

  16.7%

  22.2%

     0.0%

      3

     F

    N

        9

 56.0%

  33.0%

    0.0%

     0.0%

      3

     M            

    Y

      56

 85.7%

  10.7%

    0.0%

     1.8%

      3

     F

    Y

      35

 74.3%

    8.6%

    2.9%

     5.7%

 

 

 

 

 

 

 

 

      4

    M

    N

      61

 45.9%

  16.4%

  29.2%

     0.0%

 

      4

    F

    N

      44

 50.0%

  29.5%

    6.8%

     0.0%

      4

    M

    Y

    120

 49.2%

  19.2%

  13.3%

     0.8%

      4

    F

    Y

      53

 47.2%

  26.4%

  13.2%

     0.0%

 

 

 

 

 

 

 

 

      5

   M

    N

      22

   9.1%

  45.5%

   4.5%

     0.0%

      5

   F

    N

      16

 18.8%

  12.5%

   6.3%

     0.0%

      5

   M

    Y

      24

 41.7%

  20.8%

   4.2%

     0.0%

      5

   F

    Y

      17

 11.8%

  47.1%

  11.8%

     0.0%

 

 

 

 

 

 

 

 

  0-5

  Both

    N

    634

 31.7%

  45.1%

    7.3%

    0.2%

  0-5

  Both

    Y

    880

 44.2%

  39.0%

    5.6%

    0.5%

 

 

 

 

 

 

 

 

 

 

 

 

Table 5 cont.

Outcomes by Wagner Class, Sex and Diabetic Status

No Help

Sl Worse

AKA

BKA

Blank

LTT

?Benefit

Fails

 

0.7%

0.0%

0.0%

0.0%

4.3%

10.8%

1.4%

0.0%

 

0.7%

0.0%

0.7%

0.0%

5.2%

9.0%

0.0%

0.0%

 

0.6%

0.0%

0.0%

0.0%

1.7%

7.4%

0.0%

0.0%

 

0.0%

0.0%

0.0%

0.0%

1.7%

3.4%

0.0%

0.0%

 

 

 

 

 

 

 

 

 

 

0.0%

0.0%

0.0%

0.0%

0.0%

2.1%

0.0%

2.1%

 

1.3%

0.0%

0.0%

0.0%

5.3%

4.0%

0.0%

0.0%

 

0.0%

0.0%

0.0%

1.1%

0.0%

3.4%

0.0%

0.0%

 

0.0%

0.0%

0.0%

0.0%

11.3%

6.5%

0.0%

0.0%

 

 

 

 

 

 

 

 

 

 

0.0%

2.7%

0.0%

2.7%

2.7%

16.2%

0.0%

0.0%

 

0.0%

0.0%

0.0%

0.0%

0.0%

15.6%

0.0%

0.0%

 

1.3%

0.0%

0.0%

1.3%

1.3%

5.3%

0.0%

0.0%

 

0.0%

0.0%

1.7%

1.7%

1.7%

3.4%

0.0%

0.0%

 

 

 

 

 

 

 

 

 

 

0.0%

0.0%

0.0%

0.0%

0.0%

0.0%

0.0%

0.0%

 

0.0%

0.0%

0.0%

0.0%

0.0%

11.0%

0.0%

0.0%

 

0.0%

0.0%

0.0%

0.0%

1.8%

0.0%

0.0%

0.0%

 

0.0%

2.9%

0.0%

5.7%

0.0%

0.0%

0.0%

0.0%

 

 

 

 

 

 

 

 

 

 

0.0%

0.0%

0.0%

1.6%

3.3%

3.3%

0.0%

0.0%

 

0.0%

0.0%

2.3%

0.0%

2.3%

9.1%

0.0%

0.0%

 

0.8%

0.0%

0.8%

2.5%

8.3%

3.3%

1.7%

0.0%

 

0.0%

0.0%

0.0%

5.7%

3.8%

3.8%

0.0%

0.0%

 

 

 

 

 

 

 

 

 

 

0.0%

0.0%

18.2%

13.6%

0.0%

4.5%

0.0%

4.5%

 

 

 

 

 

 

 

0.0%

0.0%

6.3%

25.0%

18.8%

12.5%

0.0%

0.0%

 

 

 

 

 

 

 

0.0%

4.2%

12.5%

12.5%

0.0%

4.2%

0.0%

0.0%

 

 

 

 

 

 

 

0.0%

5.9%

5.9%

11.8%

0.0%

5.9%

0.0%

0.0%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

0.5%

0.2%

1.1%

1.4%

3.8%

8.2%

0.3%

0.3%

 

 

 

 

 

 

 

0.3%

0.3%

0.7%

1.8%

3.1%

4.3%

0.2%

0.0%

 

 

 

 

 

 

 

 

                In the Wagner “0” class, the patients were free of skin lesions to heal but some had complaints that totally disappeared with treatment, the small “healed” or “cured” group. The majority had claudication or rest pain. Compared to nondiabetic patients, the diabetic patients fared well: 83.5% of males and 94% of females either healed or improved compared respectively to nondiabetic males 75.6% and females 80.6% (P<0.001).  The effects of smoking and class of diabetes is discussed  below. Of the 69 patients presenting with rest pain, 34 had no diabetes, 16 type 1 diabetes and 18 type 2 diabetes; 84% were cured or improved. Major amputations occurred early in two nondiabetic patients, after an initial relapse in one nondiabetic and one Type 1 diabetic patient and, finally, later elsewhere in one nondiabetic and one type 1 diabetic patient.  Twenty-four of the 69 died after a mean +/- std dev of 2.39+/-2.73 years. Forty-five of the 69 had lived 7.09+/-4.82 years since presentation for treatment when the study was closed.

                In the Wagner “1” class, both diabetic and nondiabetic patients did well. Seven female diabetic patients (11.3%) were erratic in attendance and were listed as “blank”. One male and no females had major amputations.

                In the Wagner “2” class, diabetic patients were more likely to heal or improve than nondiabetic patients (P<0.05). The success of diabetic males was especially prominent: 88% either healed or improved compared to 64.8% of nondiabetic males. Perhaps because the nondiabetic patients had no neuropathy and had more pain, because they were harassed for smoking or wondered why they were attending a wound healing clinic for diabetic patients, 16.2% of males and 15.6% of females were lost to treatment. Overall, 1.8% of males and 2.2% of  females had major amputations.

                The Wagner “3” class included 27 nondiabetic and 91 diabetic patients and largely had osteomyelitis. They were treated as outpatients with local antibiotics and boot therapy. Debridements were rarely performed. Only 9 nondiabetic females were in this category and 1 was lost to treatment. The 91 diabetic patients did well: overall for both sexes 91.2% either healed or improved. Two females and no males had major amputations.

                In the Wagner “4” class, equal percentages of diabetic (69.9%) and nondiabetic (69.5%) patients either healed or improved. However, the diabetic patients had a modest increased risk for major amputation compared to nondiabetic patients: 3.3% vs 1.6% for males and 5.7% vs 2.3% for females. The effect of smoking in the “stable” group is described below.

                The Wagner “5” class was comprised by 46 male legs and 33 female legs. Overall 53% either healed or improved. Diabetic men were more successful in healing than nondiabetic men (P<0.05), perhaps because their neuropathy allowed them to continue in their treatment with less pain. Likewise, compared to nondiabetic legs, the female diabetic legs fared better having fewer major amputations and having a higher percentage of legs healed or improved, although the differences were not significant. All of  the legs in this category were thought to be potential candidates for major amputations. The latter were performed in 25% of diabetic and 31.8% of nondiabetic males and 17.7% of diabetic and 31.3% of nondiabetic females.

Effect of Smoking on Initial Results Related to the Wagner Classification: Smoking is a known risk factor for arteriosclerosis. The prevalence of severe arteriosclerosis obliterans has been found to be increased in diabetic patients who smoke (21).  Here, like others (22,23) we found that smoking had a detrimental effect on treatment results. The effect of smoking was examined overall and in 3 subgroups: the Wagner “0” primarily as a group with arterial insufficiency, Wagner “1” as a group requiring superficial healing and Wagner “4” as a group requiring healing of significant gangrenous areas.

                In the more numerous groups, smoking was found to have a clear deleterious effect. See Table VI. The active smokers were regularly strongly encouraged to stop smoking. As a group, they more frequently failed to progress to a satisfactory conclusion and they stabilized or left the treatment program. This effect was especially seen in the Wagner “0” group with no diabetes, Table VI.

 

Table VI

Effect of Smoking on Percentages Healed or Improved

for State of Diabetes and Wagner Classes All, 0, 1, and 4

  Wagner

   Diabetes

  Nonsmoker

    Active

    Former

  Chi Square

 

    Class

    Status

 

    Smoker

    Smoker

     P-value

 

      All

       All

       85.7

       76.2

       79.2

     P<0.01

 

       0

       All

       91.1

       74.2

       83.8

     P<0.001

 

       0                     

       None

       88.1

      65.6*

       82.0

     P<0.01

 

       0

      Type 1

       92.6

      89.5*

       88.5

          -

 

       0

      Type 2

       88.5

      76.0

       78.6

          -

 

       1

      None

     96/84**

    92/65**

      80/60**

     -/P<0.1**

 

       1

     Type 1

      95.1

      87.5

       92.1

          -

 

       1

     Type 2

      75.0

      72.7

       90.0

          -

 

       4

     None

      78.6

     71.0

       61.8

          -

 

       4

    Type 1

      80.6

     88.2

       69.2

          -

 

       4

    Type 2

      64.3

     73.3

       73.1

          -

 

 

 

 

 

 

 

 

 

 

 

 

 

*P<0.01

** sum of healing and improved/complete healing.

 

                The presence of type 1 diabetes in the Wagner “0” group was actually associated with an increased success rate compared to nondiabetic patients perhaps because of better compliance or a slightly younger average age (insulin-dependent diabetes and male sex, 67.3+/-9.75 and female sex 66.45+/-13.09 years; type 2 diabetes and male sex 70.81+/-8.23 and female sex 71.68+/-8.87 years; and no diabetes and male sex 69.39+/-12.88 and female sex 70.55+/-14.06 years). The differences due to smoking among the type 1 diabetic patients were not significant as the groups overall did well and the failures were small in number. Among the active-smokers, the 89.5% success rate for type 1 diabetic patients was significantly better than the 65.6% success rate for nondiabetic patients (P<0.01). The latter, as noted above, had the risk of a slightly older age and, perhaps, a biological sensitivity to smoking.

                Among the Wagner “0” patients with type 2 diabetes, the effect of smoking was associated especially in males with stabilization short of a complete cure. Thus, 76% of the 25 active smokers with type 2 diabetes did well while the other 24% were men who continued in the program and stabilized. For the nonsmoking men, all improved (82%) or were lost to treatment (18%).  In contrast, 21.4% of legs belonging to active male smokers and 5% of male former smokers stabilized. No female legs stabilized in this class.

                In the Wagner “1” patients with no diabetes, smoking was associated with an insignificant decrease in healing and an increase in the “improved” and “stable” categories in both sexes. An importance of smoking in this category of patients might be expected as, in the absence of diabetes, it likely played a role in the origin of their disease.

                In the Wagner “4” patients with type 1 diabetes, similar trends were seen. There were 74 men and 36 women in this category. Only 4 of the women were active smokers and 6 former smokers; 5 were healed and 5 improved. In the men, a non-significant decrease in the percentage healed and increases in the percentages improved, stabilized and lost-to-treatment were associated with smoking.

 

Major Amputations Related to Wagner Class and Walking Distance in Feet at Time of Presentation: Inability to walk at all at the time of presentation was an ominous sign; 78% of 36 limbs lost at the time of their first referral for boot therapy were functionless. For 13.8% only a distance up to 20 feet was manageable. Limited function was possible for 8.7%  of the 36 limbs; the patients generally had some accompanying neuropathy and claimed to be able to walk 50-150 feet.

                While 6.1% overall of the limbs functionless on presentation came to a major amputation, another 9.4% came to amputation later generally at another center. Late amputations were seen in all the Wagner classifications occurring respectively for classes 0-5 as follows: 6%, 5.9%, 6.8%, 17.1%, 11.7% and 12.9%. The majority of these patients, however, were still benefited by boot therapy: 36.3% healed, 30.3% improved and 9.4% stabilized ... all of these patients regaining at least partial use of their limb.

 

Time of Amputation of Diabetic vs Nondiabetic Legs:  Among the patients referred for boot therapy, the diabetic population was significantly more likely to present with a previous leg amputation, 2.3% of patients, than the nondiabetic population, 0.85% of patients (P<0.05). For diabetic legs, 2.46% had major amputations at the initial treatment episode, 1.6% at a time of a relapse and 4.14% after seeking treatment elsewhere. For nondiabetic patients, the respective risks were similar: 2.0%, 1.18% and 2.88%.

 

Percentage of Legs-at-Risk Having Early or Late Major Amputations Related to Distance of Home from Boot Center: For both sexes and for both early and late major amputations, the lowest percentage of amputations were seen in those patients living closest to the boot center. Late male amputations comprised the largest group. For them, the percentage having late major amputations was 3.90% for 0-4 miles, 8.0% for 5-10 miles, 4.5% for 11-20 miles, 10.1% for 21-50 miles, 13% for 100-200 miles and 5.3% for over 200 miles (Pearson coefficient 0.4237). The risk of distance was reduced somewhat with the use of the nursing home boot facility, which allowed many patients from a distance to continue treatment.

 

Percentage of  Legs-at-Risk Having Early or Late Major Amputations Related to Number of Surgical Vascular Procedures: Twenty-eight percent of the 308 legs which had one or multiple vascular procedures before referral for boot therapy were referred by their vascular surgeons and 72% by other sources (Fig 1).  Seventy-one of 1130 legs with ASO (6.3%) had major amputations and no vascular procedure prior to presenting for boot therapy.  In Table VII, the percentages having major amputations are given for those who had vascular procedures. It is seen that there was a significant increase in the percentage of patients coming to amputation in the four groups studied: 1) all ASO patients who had surgery before referral for boot therapy;  2) those ASO patients presenting for boot therapy with an ankle/arm index less than 0.5 and a history of vascular surgery;  3) all ASO patients who had vascular surgery after having had boot therapy; and 4) those ASO patients who presented for boot therapy with an ABI<0.5 and who subsequently had vascular surgery. The Chi square data was calculated from the larger patient groups as the expected number of amputations in the smaller groups was less than six. Likewise, the Pearson correlation data was calculated  from groups larger than nine.

 

            Table VII

Number of ASO Legs and Percentages Coming to Major Amputation (MA)

Related to Number of Surgical Vascular Procedures

before and after Boot Therapy

 

      ___________Number_of_Surgical_Vascular_Procedures__________

 

0

1

2

3

4

5

Pearson

Before Boot:

 

 

 

 

 

 

 

  All ASO:

1130L

196L

69L

25L

9L

5L

 

      %MA:

6.3%a

9.7%a

17%a

40%

56%

40%

0.959

  ABI<0.5:

183L

52L

25L

16L

6L

2L

 

      %MA:

9.8%

19.2%

20%

44%

50%

100%

0/916

After Boot:

 

 

 

 

 

 

 

  All ASO:

1274L

100L

15L

6L

-

-

 

      %MA:

6.8%b

20%b

80%

83%

-

-

0.938

  ABI<0.5:

221L

46L

10L

-

-

-

 

      %MA:

12.6%c

26.1%c

20%-

-

-

 

0.545

 

 

Relationship of Number of Vascular Procedures per Leg and Major Amputations

for Individual Surgeons:  While fourteen area vascular surgeons referred patients for boot therapy, five surgeons referred eight or more patients for a total of 165 legs.  For these five surgeons, there was a linear relationship between average number of vascular procedures they performed per leg and the number of major amputations eventually performed (Figure 3).  The relationship was highly significant (Pearson coefficient 0.921) and was also seen for the other surgeons.  Three of four other surgeons who had no amputations also had performed no vascular procedures on their patients (the fourth surgeon had done one operation on two legs).  In four of five of the other surgeons who had 0.33 to 1 major amputation per leg, they averaged two to four procedures per leg.


 

No Other Form of Treatment:  Among both diabetic and nondiabetic patients were patients for whom no other form of therapy was available either because of the nature of their disease or their circumstances.  Blood flow was restored in 13 patients with small vessel thrombosis associated with Buerger’s disease, in 2 with frostbite, 2 with exposure associated with alcoholic stupor, 4 with thrombocytosis and 7 with cholesterol emboli.  The lesions of two patients with necrobiosis diabeticorum resolved as did the lesions of a patient with rheumatoid vasculitis.  The leg lesions of patients with angina decubitus, congestive heart failure, acute renal failure, recent stroke, advanced COPD, lack of runoff and graft failure generally did well.  Little hope had been offered the 40 men and 18 women referred with ABI’s of “0” and no detectable Doppler sounds at the ankle (24, 25); they generally did well unless they had had vascular procedures.  Thus, of the 40 men, 9 of the 11 having early amputations  had previous vascular procedures (2.64 vp/leg)  as had 6 of the 9 men who had late major amputations (2.33 vp/leg).  Of the 18 women with ABI’s of  “0”, all five who had major amputations had previous bypass surgery.  In contrast, one of 11 men and none of 8 women with ABI’s of “0” and no history of previous vascular procedures had major amputations.

 

Survival Data:  Overall, for women, 356 diabetic legs with an average +/std dev age of 68.16+/-14.36 years at presentation and 295 nondiabetic legs with an average age of 72.71+/-12.86 years and for men, 551 diabetic legs with an average age of 66.43+/-10.86 and 293 nondiabetic legs with an average age of 68.79+/-13.00 were treated.  The average +/- std dev for age at death was 73.24+/-10.35 for all males, 70.40+/- 14.15 for male diabetic patients, 73/83+/-12.30 for all females and 74.47+/-13.76 for female diabetic patients.  Death of patients under age 50 years were limited to 5 male and 4 female dialysis patients.  The legs of both commonly deteriorated in the last few weeks of their lives.  No patients died during the first week of treatment.  Eight females died in the 3rd and 4th week after the start of their treatment with an average age of 80.36+/-6.96. In spite of the fact that very sick patients were treated, no patient died while receiving boot therapy at the time of death.

 

Discussion

                The patients in this report were a difficult group.  They were referred generally after other measures had failed.  Friends or relatives, who were dismayed for the patient at the progress and/or the advice given elsewhere, commonly for leg amputation, were the most common source of referral.  The patients had problems that generally had continued to deteriorate over weeks to years; it was unlikely that spontaneous improvement would occur after referral for boot therapy.  The 38.7% deterioration rate of the  “control  leg” in those patients presenting with disease in one leg was important.  It showed with Chi square analysis that the 80.5% “healed” or “improved” rate for our initial treatments was highly significant.  Again, it showed that systemic effects of booting the “bad leg” along with the protective footwear, systemic antibiotics, rest and improved metabolic control that were a part of the treatment program shared by the “control leg”, were all unable to prevent progression or development of symptoms or disease in the “control leg” of all patients.  The latter is an important point in answer to those who have wondered if our excellent results were more due to our meticulous care of the patient and the foot, agreed important facets of our care and described by others (26), rather than the boot program itself.  Finally, 38.7% of “controls” that deteriorated in spite of being under treatment for the other leg, provided another treatment group that responded nicely to boot therapy.  Other aspects of the study point to the effectiveness of the boot program.  Distance from the boot center and loss-to-treatment proved to be risk factors for major amputation.  The detrimental effect of interruptions of treatment due to weather or loss of insurance was not tabulated but was equally important.

                The number of eventual major amputations is reported because it is a definitive endpoint.  All amputations are included lest there be a bias in their exclusion.   Thus, six leg amputations in which there was no arterial inflow from the pelvis are included as are all of the Wagner 5 patients.  Many of these patients had disease advanced enough for us to have reasonable refused care.

                It is difficult to compare outcomes among various studies because of variations in such factors as types and classification of lesions, definitions of success,  duration of allowed hospitalization, follow-up periods and perceived indications for vascular surgery.  Variation in the latter may explain why one group reports a 5-year distal bypass patency rate of 74% in diabetic patients (27) while another finds a three-year patency rate of  43% (28).  Distal bypass into the foot may likewise vary in success as its usage is extended from those with only arteriosclerosis obliterans to those with neuropathic lesions and a better vascularized foot.  The use of the Wagner classification has been reported in two studies.  Apelqvist et al utilized it in their study, which began enlisting patients in 1983 and was reported in 1989 (29). They reported healing with or without amputations for Wagner 1-4 groups in 88, 78, 57 and 2.9% of patients respectively; 25.4% had major amputations.  Calhoun et al utilized it and the Wagner treatment algorithms in treating 855 foot infections among 355 patients; they performed 32 vascular procedures; 9 AK, 121 BK, 8 Syme, 21 metatarsal and 158 toe amputations; 24 ankle disarticulations; and 72 ray resections (3).  It is apparent that our patients had far fewer procedures and losses than described in these reports, especially in the Wagner 3 and 4 classes.  Both reports recommend a team approach to care and provide an opportunity to each member of the team to perform.

                Our data relevant to vascular surgery would suggest that vascular surgery is a significant risk factor against leg survival.  It is to be appreciated, however, that patients having successful procedures were not referred to our program.  On the other hand, our data is consistent with the report of Morris et al (3). The latter showed with serial arteriograms in patients with bilateral ASO that occlusive disease progressed significantly more rapidly in bypassed legs vs their control legs. Our patients with ischemic legs who had no vascular procedures either before or after boot therapy had usually been thought to be poor candidates for surgery because of poor runoff, lack of a vein or other technical consideration.  Conversely, those having surgery were thought to have a reasonable chance of benefit by their surgeons.  The data on individual surgeons points to a variation in the inclination to operate among various surgeons or perhaps variation in their skills.  Because of the experience reported in this study,  I recommend appropriate inlet procedures in symptomatic patients with vascular occlusions above the upper thigh and angioplasties of short occlusions  in the iliacs and the superficial femoral and popliteal arteries.  I avoid angioplasties below the popliteal artery and bypass procedures with poor runoff.  Failure of such procedures significantly increases the duration of subsequent boot therapy.  I avoid all invasive procedures in patients with modest symptoms due to occlusions below the midthigh.

                The increased amputation rate found among our patients referred from general surgeons suggests that their aggressive debridement procedures may also be a significant risk for amputation.  We rarely refer patients for such procedures.

                Patients with acute severe ischemia are a difficult group that are generally referred early in the course of their immediate problem.  Sayers et al had an 8% immediate amputation rate, a 30-day salvage rate of 79% and a mortality of 20% in such patients (30).  Mills et al reported need for more proximal amputations and loss of legs due to late referral (31).  In Table 3, we found that early referral was associated with no overall difference in leg loss because of the presentation of difficult legs we would likely have lost regardless or time of referral.  The low loss of legs in the author’s own practice, however, suggests early referral is important.  While the costs of later referral were not determined, it was likely considerable as the duration of treatments paralleled the severity of the presenting lesions.

                Economic pressures have been and continue to color the results and effectiveness of our program.  In the fee-for-service sector, both medical and surgical physicians are interested in maintaining their practice and their input into patient care frequently ordering expensive scans, MRI’s and additional physician consultations.  The effect of such activity is pressure for some form of action, debridements, amputation or bypass.  The current HMO environment delays appropriate consultations and treatment commonly in our experience resulting in significant progression of infection and necrosis before treatment is initiated.  Then, when the leg is healed, there is a tendency for the consulting HMO reviewer to declare that the treatments were unnecessary and, hence, should not be reimbursed.  Again, the HMO’s encourage outpatient care where some weight-bearing proves unavoidable; hence, we had a patient under treatment for a year who healed within a week when he was hospitalized for a heart attack.  Economic pressures,  however, continue to show the need for programs such as ours.  We do most of our therapy in the outpatient area.  Left to our own choices, we do not use home nursing services or home intravenous antibiotic infusions.  Our use of local antibiotic injections has proven economical and safe over weeks to months and free from complications of catheter infections and thrombosis and toxic effects on renal or ear function.  It is also rapidly effective in arresting infection and further cell necrosis while intravenous antibiotics may not (32).   I prescribe an oral antibiotic to avoid septic emboli but rely on the locally injected antibiotic to ensure a high local antibiotic concentration and on the boot therapy to disseminate the antibiotic locally near the lesion.  In this fashion, we have been successful in sterilizing most osteomyelitic lesions and have not required debridement procedures.

                The economic costs of diabetic foot problems have long been known to be immense.  In 1981, Jonsson and Persson found peripheral vascular disease to be the most costly complication of diabetes in terms of hospital bed utilization (33).  Foot problems are the most common reason for admission to the hospital for the diabetic population, constituting , for example, 20.4% of admissions in Dutch hospitals (34).  Statistics of success for individual clinics may be misleading as patients may have a multiplicity of admissions to different institutions and specialties (35).  Prolonged hospital bedrest has historically been helpful in healing neuropathic patients but is considered too expensive today.  Length of stay for patients coming to amputation is over a month, 34.6 days in New Jersey for example (36).  Bypass surgery shorten the length of stay but has its own perioperative mortality (37, 38), has not had an overall beneficial effect on amputation  rates and is commonly followed by new hospitalizations for bypass revisions and occasional later amputations.  Patients healing their first ulcers commonly relapse; Apelqvist found 34%, 61% and 70% relapse rates at one, three and five years respectively (39).  Those healing transmetatarsal amputations likewise have a poor prognosis: 28% of the patients of Mueller et al required higher amputations (60% within the first month) (40) while 55% of the patients of Quigley et al met the same fate (41).  The older age and associated coronary and cerebral vascular disease of these patients is associated with a considerable mortality: 15.3% for Apelqvist’s patients before healing (39);  for leg amputations an overall 10.1%  inhospital rate for VanBoskirk (36) and perioperative rates of 20 to 25% described by others (5,10,42,43).  Long-term survival is also poor.  Apelqvist found 58% of those with primary healing and 27% of those with an initial amputation surviving at five years (39).  Again for amputees, Waugh reported an overall mortality of 40% at one year, 50% in two years and 76%  at three years (35).  Survivors  may not fare well either.  Perhaps 10% of amputees leave the hospital for a nursing home.  Only younger and healthier patients return to a meaningful social life with appropriate prostheses (10,44).  The morbidity of foot problems in elderly diabetic patients is not likely to greatly benefit from unsupported foot education programs: Thomson and Masson found that only 39% of such patients could touch their toes and 14% could respond to plantar lesions (45).

                Against such dismal literature our patients seem to fare very well.  Our overall amputation rate is low.  We have had no complications.  Our early death rate is minimal and those patients dying with the first  30 days of treatment generally had an advanced age (80.4+/-7 for females and 80.8+/-9.2 for males).  Our low loss of life during treatment may be associated with the cardiac-assist action of the Circulator Boot Systems.  In recent years, we have cut hospital costs by emphasizing outpatient care even in patients with advanced disease.  Unfortunately, we have found healing time prolonged by ambulation especially in patients with lesions on weight-bearing surfaces.  Thus, one middle-aged lady with angina-decubitus took over a year to heal her osteomyelitic lesions over her first metatarsal head and in the metatarsal-phalangeal joints of her 2nd and 3rd toes.  Still, she is alive, her angina is less and she is ambulatory and with her family.

References

 

 1)  Humphrey LL, Ballard DJ, Butters MA, Palumbo RJ, Hallett JW: The epidemiology of lower extremity amputation in diabetes: a population based study in Rochester, Minnesota.  Diabetes 38: suppl 2:33A, 1989.

 2)  Eickhoff HJ, Hanson B, Lorentzen JE: The effect of arterial reconstruction on lower limb amputation rate.  Acta Chir Scand 502:181-187, 1980.

 3)  Morris PE,Hessel SJ, Couch NP and Adams DF: Surgery and the progression of the occlusive process in patients with peripheral vascular disease.  Radiology 124:343-348, 1977.

 4)  Tunis SR, Bass EB and Steinberg EP: The use of angioplasty, bypass surgery, and amputation in the management of peripheral vascular disease. N Engl J Med 325:356-62, 1991.

 5)  Sayers RD, Thompson MM, Varty K, Jager C and Bell PRF:  Changing trends in the management of lower limb ischemia: a 17-year review. Br J Surg  80: 1269-1273, 1993.

 6)  Taylor LM Jr, Porter JM: The clinical course of diabetics who require emergent foot surgery because of infection or ischemia.  J Vasc Surg 6, 454-9, 1987.

 7)  Bamberger DM, Daus GP, Gerding DN: Osteomyelitis in the feet of diabetic patients: Long-term results, prognostic factors and the role of antimicrobial and surgical therapy.  Am J Med 83:653-660, 1987.

 8)  Calhoun JH, Cantrell J, Cobos J, Lacy J, Valdez BR, Hokanson J and Mader JT:  Treatment of diabetic foot infections: Wagner classification, therapy and outcome.  Foot & Ankle 9:101-108, 1988.

 9)  Levy LA:  Survey of socioeconomic and medical implications of diabetes and the lower limb.  J Am Pod Med Assoc 83:293-294, 1993.

10)  Greant Ph and Van den Brande P: Amputation in elderly and  high risk vascular patients.  Ann Vasc Surg 4:288-290, 1990.

11) Dillon RS: An end-diastolic air compression boot for circulation augmentation. J Clin Engineering  5:63-66, 1980.

12) Dillon RS: Effect of therapy with pneumatic end-diastolic leg compression boot on peripheral vascular tests and on the clinical course of peripheral vascular disease.  Angiology 31:614-638, 1980.

13)  Dillon  RS: Treatment of resistant venous stasis ulcers and dermatitis with the end-diastolic pneumatic compression boot (TM).  Angiology 37: 47-56, 1986.

14)  Dillon RS: Successful treatment of osteomyelitis and soft tissue infections in ischemic diabetic legs by antibiotic injections and the end-diastolic pneumatic compression boot.  Ann Surg 204:643-9, 1986.

15)  Dillon RS:  Treatment of osteomyelitis in diabetic foot with systemic and locally-injected antibiotics and the end-diastolic compression boot - case studies. Vasc Surg 24:682-685, 1990.

16)  Dillon RS: Management of soft tissue infections in elderly persons with diabetes.  Geriatric Medicine Today 6:21-35, 1987.

17)  Dillon RS: Role of cholinergic nervous system in healing neuropathic lesions:  Preliminary studies and prospective, double-blinded, placebo-controlled studies.  Angiology 42:767-778, 1991.

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