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ORIGINAL ARTICLE

Limb Salvage Experience in a Multidisciplinary Diabetic Foot Unit

Per E. Holstein, MD, DRMEDSC
Steffen Sørensen, MD

OBJECTIVE— To assess the results of the strategy used in avoiding major amputations in patients admitted to a vascular surgical department with a new multidisciplinary diabetic foot unit.

RESEARCH DESIGN AND METHODS— The study was retrospective. A total of 162 patients (172 limbs) were classified into three groups. Group A1 had limb-threatening ischemia and were undergoing revascularization (85 patients, 91 legs). Group A2 had limb-threatening ischemia, but revascularization was not feasible for them (23 patients). Group B had foot ulcers due to peripheral neuropathy and did not require arterial reconstruction (54 patients, 58 legs).

RESULTS— In group A1 there were 115 revascularizations; 42 conduits had outflow to crural arteries and 14 to pedal arteries. Resection of gangrene was required in 43% of the limbs. The chances of preserved limb at 1 and at 24 months were 95 and 85%, respectively, and the chances of patient survival were 89 and 64%. In group A2, the chances of preserved limb at 1 and at 24 months were only 35 and 17%, respectively, and the chances of patient survival were only 64 and 16%. In group B, 51 of 58 limbs suffered invasive infection; debridement of the ulcers required resection of toes or part of the foot in 64% of cases. The chances of preserved limb at 1 and at 24 months was 98 and 86%; the chances of patient survival were 98 and 68%. Ankle and toe systolic pressures were less suitable than repeated clinical examinations in deciding the need for revascularization.

CONCLUSIONS— Major amputation can be avoided in about 80% of patients with limb-threatening ischemia and in about 95% with foot ulceration complicated with infection. Multifactorial treatment of the complex foot lesions by a multidisciplinary foot care team is considered mandatory to obtain satisfactory limb salvage.

Diabetes Care 22 (Suppl. 2):B97–B103, 1999

In the St. Vincent Declaration Action Programme 1992, one of the 5-year targets outlined was to reduce by one-half the rate of lower-limb amputation in people with diabetes (1). A number of reports document a decrease in amputation rates of 40–85% (2–16). In 1990, major amputations in people with diabetes had been reduced by 56% in this hospital after the introduction of bypass grafts to crural and pedal arteries (10). Based, moreover, on favorable experience with foot revisions and foot care in diabetic vascular patients (17), a multidisciplinary diabetic foot unit was established 1 July 1993 in the division of vascular surgery. The team included diabetologists, vascular surgeons, an orthopedic surgeon with special interest in diabetic foot problems, nurses, chiropodists, and custom shoemakers. After the establishment of this unit, the number of major amputations decreased by 42% in the catchment area during the 2nd year (18).

Thus, it has been documented that the St. Vincent requirement on amputations can be fulfilled. There is, however, a need for detailed information on actual therapeutic strategy used for avoiding amputations in diabetic limbs threatened by often complex foot lesions. This article analyzes retrospectively the results of arterial reconstruction, treatment of infection, and foot surgery in patients hospitalized in a specialized diabetic foot unit.

RESEARCH DESIGN AND METHODS— The catchment area had ~380,000 inhabitants, with 6,400 people with diabetes as estimated from recent epidemiological investigations. People with diabetes were served by three different hospitals. The multidisciplinary diabetic foot service was organized in the vascular surgery department as centralized in the present hospital. The series of 162 patients is consecutive and includes all patients with diabetes hospitalized for foot lesions in the first 12 months of operation (1 July 1993 to 30 June 1994). The patients admitted were recruited from the outpatient clinic, from other departments or hospitals in the catchment area, and from general practice.

Evaluation
All patients with foot problems and no history of diabetes were tested with fasting blood glucose determinations, and the patients were classified as having type 1 or type 2 diabetes according to previous therapy. The patients were evaluated with measurement of the toe and ankle blood pressure with strain-gauge technique. Chronic critical ischemia was defined according to the European consensus definition (Table 1) (19). Peripheral neuropathy was tested for by clinical examination and by biothesiometry. All patients with critical ischemia in whom it was physically feasible for a revascularization procedure had an angiogram. Moreover, angiograms were made in cases with progressive or persistent ischemia, even when digital or ankle pressures were above "critical" levels.

Treatment
Blood glucose regulation and related medical control were undertaken by diabetologists, who visited the department at least twice a week and more frequently when required. Revascularization was performed in limbs with progressive or persistent ischemia that did not respond to more conservative measures. With regard to physiological feasibility for vascular reconstruction, the patient's functional level was decisive. Patients who were completely dependent on others, i.e., with chronic mental organic deficiency as typically cared for in chronic wards, were not offered vascular reconstruction. On the other hand, no patient able to manage daily living in his or her own home was excluded from revascularization in this series if a major amputation was the inevitable alternative. The preoperative work-up was undertaken by the anesthesiologists. In deciding the technical feasibility of infrapopliteal bypass procedures, the runoff was considered sufficient whenever a segment of a crural or pedal artery of 3 cm or more had a patent lumen. When the greater saphenous vein was inadequate, ectopic vein was used, possibly in combination with a synthetic graft (composite graft). All bypass reconstructions below the knee were included in a postoperative surveillance program with triplex scanning of the graft after 10 days, 6 weeks, and 3, 6, 9, 12, 18, and 24 months. When progressive stenosis was revealed by this program, surgical revision was made. In the case of graft occlusion with reappearance of ischemic symptoms, a new vascular reconstruction was attempted if at all possible. After revascularization, gangrenous tissue on the feet was excised when deep structures were involved, i.e., spontaneous autoamputation by demarcation was not used in such cases. Excisions of gangrene were made in conjunction with the vascular procedure when infection was present. Otherwise, it was postponed for about a week for optimization of the local arterial supply (20). Patients with digital pressures above the critical level of 30 mmHg were treated with more conservative means, i.e., debridement of the ulcer and treatment of invasive infection with minor amputations and revisions as required. Invasive infection was treated with surgical decompression and excision of all infected and nonviable tissue. Routine antibiotics were dicloxacillin 1 g X 2 and ampicillin 1 g X 2, with revision according to swab cultures. Assistance from microbiologists was available. Multiresistent cultures, which are rarely encountered in this country, did not occur. After surgical treatment of the feet, weight-bearing was postponed until bones and tendon sheaths were sealed with granulation tissue. The chiropodists adjusted the therapeutic shoes, controlled usual foot wear, and manufactured individual insoles according to functional imprints. The entire staff was involved in patient education as regards foot care, and foot care instructions were repeated over and over on an individual basis by the chiropodists. An orthopedic shoemaker assisted with solution of shoe problems and provided individual shoes. After healing of foot ulcers and correction of shoes and insoles, the patients were referred to private chiropodists for lifelong regular foot care, the cost of which was reimbursed by the public health care system.

Subjects
In the retrospective evaluation, three groups of patients emerged; the demographic data are shown in Table 2.

Group A1 included 85 patients (91 limbs) undergoing arterial revascularization (75 patients with ulcer/gangrene, 10 patients with rest pains).

Group A2 included 23 patients (23 limbs) with a need for revascularization but in whom arterial reconstruction was not feasible. It consisted of 6 patients in whom reconstruction was technically nonfeasible as judged by the angiogram and 14 patients in whom reconstruction was nonfeasible because of mental organic syndromes and/or lost ability to walk (no angiogram) and living in chronic-care wards or completely dependent on home nursing. Further treatment in the diabetic foot center was considered futile in this group, and the patients were discharged for treatment or observation elsewhere. Finally, three patients died a few days after admission from complicating diseases.

Group B included 54 patients (58 limbs) with severe foot ulcerations and peripheral neuropathy requiring treatment for invasive infection (51 limbs) and/or correction of foot deformity who, because of a favorable response to conservative means, did not need arterial revascularization.

Follow-up
All surviving patients who had been treated for their foot disorder and who had not suffered major amputation were examined 24 months after the opening of the diabetic foot center. Only one patient was lost to follow-up, although he was known to be alive at his usual address. Official records were used to determine possible death in patients who had had major amputation.

Statistical analysis
Kaplan-Meyer's life-table method was used to calculate graft patency, limb survival, and patient survival. The ² test was used for comparing mortality and amputations in type 1 and type 2 diabetes.

RESULTS

Toe and ankle blood pressures
According to toe and ankle blood pressures (Figs. 1 and 2), all but four limbs treated with arterial reconstruction had chronic critical ischemia according to the European consensus definition (19). In these four limbs, progressive ischemic lesions were reversed by the revascularization. As regards ankle blood pressures, no limb with pressure values below 75 mmHg healed without arterial reconstruction.

Figure 1—Ankle systolic pressures at admission. , group A1; , group B; pp, palpable pulsations in the dorsal pedal and/or posterior tibial artery; falsely, noncompressible arteries causing falsely high pressures.

Figure 2—Toe systolic pressure at admission. , group A1; , group B; pp, palpable pulsations in the dorsal pedal and/or posterior tibial artery.

Group A1: Revascularization
Table 3 shows the revascularization procedures in 91 ischemic limbs, and Table 4 shows new (i.e., re-do) reconstructions and graft revisions. In 56 of 109 revascularizations, the graft was infrapopliteal, 42 to crural and 14 to pedal arteries. Of these 56 grafts, 43 were greater saphenous in-situ vein bypasses, and 13 were vein grafts from the other leg or arms or vein graft combined with synthetic graft (composite graft). The results of re-do procedures were limb salvage in 8 of 15 limbs. In graft revisions, limb salvage was obtained in all cases.

The mean observation time in group A1 was 12 months (range 0.5–24 months). Figure 3 shows the cumulated primary graft patency—i.e., the graft patency as assisted by revisions—which was 79% at 1 month and 61% at 24 months. Secondary patency—i.e., the graft patency as assisted by revisions and by re-do procedures—was 92% at 1 month and 70% at 24 months. The corresponding chance of a preserved limb, i.e., the cumulated limb survival, was 95% at 1 month and 84% at 24 months (Fig. 4).

Figure 3—Group A1: Primary and secondary cumulative assisted patency (± 2 SD) of arterial revascularizations.

Figure 4—Cumulative limb survival (± 2 SD). In group A2, the limb survival is statistically significantly worse than in groups A1 and B, between which the difference is not statistically significant.

Major leg amputations
Twelve legs had postreconstruction major amputation. Four of these were made in spite of an open graft; one after Chopart's amputation with progressive necrosis; and three because of progressive heel necrosis. Poor compliance, particularly in the weight-loss regimen, was the decisive factor for major amputation in three of these cases. Among the other eight major amputations, six were performed after two or three revascularization attempts and two only after a single revascularization attempt. Of 12 amputations, 6 were made after infrapopliteal bypass procedures, 2 of these after bypass to pedal arteries. This indicates that the limb salvage after very distal bypass procedures was equal to more proximal conventional reconstructions.

Treatment of gangrene
In 39 of 91 (43%) revascularized limbs, an open resection of one or more toes or some part of the foot became necessary. The total number of surgical foot procedures was 59. The feet healed by 5 months on average (range 1–23 months). Handmade individual shoes were made for 26 of 85 patients.

Follow-up
At follow-up, four patients had residual small ulcerations and one had a new ulcer. No patient had rest pains and all were capable of independent walking.

Figure 5—Cumulative patient survival (± 2 SD). The survival in group A2 is statistically significantly worse than in groups A1 and B, between which there is no statistically significant difference.

Mortality
Nine patients (10%) died within the 1st month after revascularization from cardio- or cerebrovascular disease. Only one had had more than one revascularization procedure. Two died after postrevascularization major amputation. Five were between 78 and 86 years of age. Seventeen patients died later after discharge. The Kaplan-Meyer estimate on chance of survival for patients is shown in Fig. 5.

Group A2: Limb-threatening ischemia in patients in whom arterial reconstruction is not feasible
Only six limbs in six patients physically suitable for arterial reconstruction were found technically nonfeasible by the angiogram (Table 5), and one of these had an occluded infrapopliteal bypass. One patient died before amputation could be performed. Five patients had a below-the-knee amputation, and two of them died within 4 months. Among the 14 patients who were physiologically not suitable for arterial surgery, only 1 patient survived 24 months without major amputation. The poor survival of limbs and patients is shown in Figs. 4 and 5.

Group B: Foot lesions not requiring arterial reconstruction
Hospitalization for this group of patients, who all had peripheral neuropathy with a history of painless ulceration, was caused by infection in 51 of 58 legs. According to Wagner's classification (21), as essentially based on the morphology, Table 6 shows the severity of the lesions. In 15 cases, gangrene was caused by infection and did not require vascular reconstruction. The adequacy of this evaluation is evidenced by the satisfactory clinical course. The only limb requiring early major amputation had a well-perfused foot, but the infection had progressed to an open septic arthritis in the ankle joint and was considered to be a nonreversible lesion.

Treatment
Regular debridement of all wounds included surgical resection of toes and/or parts of the feet in 37 feet (64%). Of 54 patients, 30 were fitted with handmade individual shoes.

Leg amputations
The patient with a nonreversible lesion mentioned earlier was the only case requiring early major amputation. Two patients had a leg amputation later because of new infections. In one patient, a Chopart amputation performed because of chronic osteomyelitis broke down due to recurrence of osteomyelitis. In another patient with lymphoedema of the legs and with poor compliance, extensive invasive infection from new ulcerations caused nonreversible tissue necrosis. Thus 3 of 51 legs (6%) with invasive infection were amputated during the time of observation. The survival of limbs and patients are shown in Figs. 4 and 5.

Follow-up
The median time of observation was 13 months (range 2–24 months). At follow-up, 11 legs had foot ulcers (19%): 6 were residual small ulcers that had not yet healed and 5 were relapses or new ulcers. Eleven other legs (19%) had had a relapsing or new ulcer that had healed, and two had had ulcers with infection leading to major amputation as described. Thus, 18 legs (31%) suffered relapse or new ulceration during follow-up.

Healing and arterial perfusion
In the 22 legs with persistent or recurrent ulceration, 7 had palpable pulsations in the foot arteries. The average toe pressure in the other 15 legs was 60 mmHg (range 28–105 mmHg). Among the 33 legs that healed uneventfully, 4 legs had palpable pulsations and the average toe pressure in the rest was 66 mmHg (range 15–165 mmHg). Thus, healing problems were not related to perfusion in this group of patients.

Type 1 and type 2 diabetes
There was no statistically significant difference between type 1 and type 2 diabetic patients in the period of observation as regards amputations (12/61 [19.6%] vs. 17/111 [15.3%] limbs, P = 0.61) or as regards mortality (21/61 [34.4%] vs. 31/111 [28%] patients, P = 0.47).

CONCLUSIONS— This article de-scribes the limb-salvage policy in a new diabetic foot unit in patients admitted during its 1st year of operation. The pattern of lesions are complex, caused by neuropathy, infection, ischemia, or a combination of these factors. The main result is that the strategy described resulted in a satisfactory limb survival.

Limitations
As indicated, treatment of diabetic foot problems was intended to be centralized in the current department. But the possibility exists that some patients with threatened legs were not admitted, as the organization was new. However, the total number of major amputations in people with diabetes in the whole catchment area of 380,000 people was 46 in 1993 and decreased to 28 in 1994 (18). This last figure corresponds with the total number of major amputations in the present series: 29 performed during a median follow-up period of ~1 year. For this reason, we feel justified in assuming that nearly all diabetic patients undergoing major amputation in the catchment area were evaluated in the department.

Epidemiology of major amputations in Denmark
The number of major amputations in people with diabetes is decreasing, which is related to the increasing use of infrapopliteal bypass reconstructions and an increasing awareness of diabetic foot problems (11,15). During the period 1987–1993, the incidence of major amputations decreased from 11 to 8 per 100,000 people, i.e., 27%. The present multidisciplinary foot clinic is, however, the first centralized unit established in Denmark, and in this hospital large reductions in amputation numbers have been reported. Over a period of 15 years, the numbers of type 1 diabetic patients living in their own home have decreased by 64% and in type 2 diabetic patients by 91% (22). The previously high incidence of major amputations in the center of Copenhagen is now 7/100,000, and about one-third of these are in a chronic-care ward.

Limb-threatening ischemia
Only 6/114 (5%) limbs were excluded from vascular reconstruction for technical reasons, and 14 (12%) were excluded for physiological reasons. This is in accordance with data from other centers with aggressive limb-salvage policy (23–25). Moreover, this result represents a major improvement in limb-salvage policy in the present area as compared with the situation about one decade ago: at that time, no patients with diabetes over the age of 75 years were found technically suitable for revascularization (26).

Our report also demonstrates that re-do arterial reconstruction in the case of graft occlusion is worthwhile and that postreconstruction major amputation was not more frequent in legs with very distal conduits.

Aggressive attempts toward a high rate of limb salvage imply revascularization even in feet with extensive gangrene, as substantiated by the high number of foot revisions. This policy may, however, sometimes end up with a major amputation in spite of a well-functioning arterial conduit. The lesson to learn from our four cases is that such attempts are rarely worthwhile in patients with poor compliance.

All patients who saved their leg retained their capability of walking. Among the revascularized patients, this was at an expense of on average 1.5 revascularization procedures and ~0.7 foot revisions per limb during an average follow-up period of 1 year. This is comparable to other reports documenting 2.8 procedures over 3 years (27) or 3.3 procedures over 5 years (28). The primary reconstruction procedure can therefore be seen as only the first step in a continuous commitment, with reconstructions, foot surgery, debridements, follow-up, and revisions necessary to keep the legs viable and the patients mobile. This commitment should be seen in the light of the alternative, major amputation, where only about half of surviving patients regain the capability of walking (29); a significant number of amputees have to be cared for permanently in chronic wards. Comparative cost-benefit investigations have consistently shown somewhat lower or equal costs for arterial reconstructions compared with amputations (30–35). Thus, revascularization is preferable to major amputation (23–25,30–36).

The survival in people undergoing arterial reconstruction and amputation is reduced, particularly in people with diabetes, and our mortality figures are in line with other recent reports (24,29,37,38). Because vascular reconstruction can be carried out with a mortality not exceeding the mortality in major amputation (39), our policy was to offer rearterialization whenever a major amputation with the inherent morbidity and mortality was the inevitable alternative and provided that independence could be maintained. In this article, we have also shown the poor results in patients with limb-threatening ischemia who could not be treated by revascularization for technical or physiological reasons. The patients physiologically unfit for revascularization were in all 14 cases completely dependent on others, mainly due to organic mental deficiency, and a major amputation would make little difference in their lifestyle. The poor fate in these patients, who will constitute a smaller or larger fraction of any consecutive series of patients with critically ischemic limbs, should not detract subsequently from the value of revascularization. In looking at the 85 patients with vascular reconstruction in addition to those 6 not suitable for revascularization due to technical points, who all had a lifestyle by and large independent of others, major amputation was required in only 17 of 97 limbs, i.e., 17%.

Ulceration and infection
It is preferable to avoid costly revascularization procedures, postoperative morbidity, and mortality when more conservative means can maintain healing of the lesions. As documented, nearly all cases with toe pressures of >30 mmHg could be managed without revascularization. This group consisted mainly of limbs threatened by infection originating from neuropathic ulcerations; in one-third of the cases, the infection was so severe that gangrene had developed. The literature reports major amputations in 8–40% of patients after infection (40). Our figure of 5% compares favorably, and it is crucial that these patients are referred without delay to a specialized diabetic foot center. The high number of new or relapsing ulcers in this group emphasizes, moreover, the need for lifelong foot care. Some would argue for using revascularization more frequently in the case of ulceration, but in group B, persistent or relapsing ulceration was not related to the level of arterial perfusion.

Comments on the definition of chronic critical ischemia
The finding that 93% of the limbs with toe blood pressure of >30 mmHg could be managed without revascularization confirms previous studies on wound healing and prognosis in relation to toe pressures (41–44) and is in line with the European consensus definition of chronic critical ischemia. There was, however, an overlap between limbs with and without a need for revascularization in the toe pressure range of 15–45 mmHg. Thus, a cutoff point of 30 mmHg should not be decisive in determining the need for arterial reconstruction. An ankle pressure cutoff point of 50 mmHg is even more questionable. Other investigators have also reported this value as too low and too inaccurate in the definition of critical ischemia (45,46). Our experience that clinical examination, often repeated, is more important than cutoff pressure points in patients with borderline pressures in determining the need for revascularization in the individual patient is in line with recent trends in the ongoing debate on definitions of critical ischemia. Pressure values are, however, important in the quantitative diagnosis of occlusive arterial disease, in rough estimates in the daily practice on the potential of wound healing, and in documenting results of limb-salvage strategy.

Finally, it should be emphasized that satisfactory limb salvage, which can be obtained in limb-threatening ischemia as well as in ulceration with infection and necrosis, has eliminated today the misconception that microvascular involvement of the foot precludes successful treatment.

In conclusion, arterial reconstruction is possible in 95% of legs with limb-threatening ischemia in people with diabetes and who are not dependent on chronic institutional care. Thus, major amputation can be avoided in ~80% of cases. In legs with neuropathic ulceration complicated with invasive infection and/or noncritical ischemia, management with antibiotics, immobilization, surgical debridement including resections on the feet, and a careful follow-up program as carried out by a multidisciplinary foot care team may limit major amputations to ~5%. The multifactorial treatment of the complex foot lesions in people with diabetes requires a centralized multidisciplinary foot care team.

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From the Department of Thoracic and Vascular Surgery L and the Copenhagen Wound Healing Center, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.

Address correspondence and reprint requests to Per Holstein, Copenhagen Wound Healing Center, University of Copenhagen, Bispebjerg Hospital, DK-2400 Copenhagen NV, Denmark.

Received for publication 23 June 1998 and accepted in revised form 9 November 1998.

This article is based on a presentation at a satellite symposium of the 16th International Diabetes Federation Congress. The symposium and the publication of this article were made possible by educational grants from Hoechst Marion Roussel AG.

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