Evaluation of a collagen-alginate wound dressing in the management of diabetic foot ulcers.

Efficacy and safety of a collagen-alginate topical wound dressing (FIBRACOL Collagen-Alginate Wound Dressing) in the treatment of diabetic foot ulcers was compared with that of regular gauze moistened with normal saline. Seventy-five patients with foot ulcers were assigned randomly in a 2:1 ratio to the collagen-alginate test dressing or the gauze dressing. At the end of the study, the mean percent reduction of the wound area was 80.6% +/- 6% in the collagen-alginate dressing group and 61.1% +/- 26% in the gauze dressing group (p = .4692). Thirty-nine (78%) patients treated with the collagen-alginate dressing achieved > or = 75% wound area reduction, compared with 15 (60%) of gauze-treated patients. Complete healing was achieved in 24 (48%) of the collagen-alginate dressing group and 9 (36%) of the gauze dressing group. Wound size, when averaged over the 8-week period and with the duration of the ulcer taken into account, was reduced significantly in the collagen-alginate dressing group, as compared with the gauze dressing group (df = 1, p = .0049). It is concluded that the collagen-alginate test dressing is as or more effective and safe as the currently used treatment.

Neuropathic ulcerations plantar to the lateral column in patients with Charcot foot deformity: a flexible approach to limb salvage.

Neuroarthropathy of the midfoot may lead to a structural deformity that predisposes the diabetic patient to skin breakdown and ulceration. In some cases, conservative management is not adequate, making surgical intervention necessary. The authors performed a retrospective study to look at those patients who required surgical intervention for a specific pattern of neuroarthropathy. Over a 2 1/2-year period, 32 feet (31 patients) underwent surgical procedures for treatment of nonhealing neuropathic ulcerations beneath the lateral column of Charcot feet. All feet underwent exostectomy with 17 undergoing excision of the ulcer with primary closure, 8 closure via rotational fasciocutaneous flap with transpositional intrinsic muscle flap, and 6 through an incision placed adjacent to the ulcer. One patient whose ulcer was healed at the time of surgery had the incision placed directly over the prominence. Overall, 29 of 32 feet maintained functional limb salvage. This included eight patients who required revisional surgery, either by resection of more bone or creation of a local flap for coverage. Life-table analysis resulted in an 89% overall success rate. The results show that a flexible approach to skin and soft tissue coverage is necessary to heal these patients, provided attention is directed to the underlying bony prominence.

The effect of arterial reconstruction on the natural history of diabetic neuropathy.

OBJECTIVE: To determine whether reversal of hypoxia slows the progression of neuropathy. DESIGN: Cohort study with a mean follow-up of 19.2 months. SETTING: Institutional and private hospital. PATIENTS: A volunteer sample of 55 patients with diabetes (mean age, 62 years; range, 30-74 years; mean duration of diabetes, 21 years; range, 1-57 years) requiring lower-extremity arterial bypass. Twenty-one successfully treated patients were reexamined at the conclusion of the study. Neuropathy and hypoxia were assessed the day before the operation and during the follow-up visit. INTERVENTION: Lower-extremity arterial reconstruction. MAIN OUTCOME MEASURES: Peroneal nerve conduction velocity and transcutaneous oxygen tension. RESULTS: In the leg operated on, the peroneal nerve conduction velocity remained unchanged during the follow-up period (preoperative, mean [+/- SD] 35.79 +/- 6.02 vs postoperative 35.33 +/- 7.51 m/s; P > .05), but deteriorated in the leg not operated on (36.68 +/- 6.22 vs 33.64 +/- 7.30 m/s; P < .05, Wilcoxon signed rank test). Transcutaneous oxygen tension increased in the revascularized extremity (mean [+/- SD] 40.62 +/- 24.76 vs 66.73 +/- 14.89 mm Hg) but remained unchanged in the leg not operated on (56.76 +/- 17.07 vs 62.00 +/- 15.66 mm Hg; P > .05). Of the entire cohort, 5 patients died during the study period. Graft occlusion occurred in 10 (17%) of 59 extremities. Subset analysis disclosed that the preoperative transcutaneous oxygen tension was significantly higher in the successfully revascularized extremities (41.98 +/- 23.58 vs 24.10 +/- 21.50 mm Hg; P < .001). CONCLUSIONS: Reversal of hypoxia halts the progression of diabetic neuropathy, lending further support to the role of hypoxia in the pathogenesis of nerve destruction in diabetes mellitus. Preoperative transcutaneous oxygen tension is lower in patients with bypass failure, but the severity of neuropathy does not affect the outcome of the operation.

Difference in treatment of foot ulcerations in Boston, USA and Pisa, Italy.

Primary care of the diabetic patient with foot ulcer can be provided by medically or surgically trained practitioners. We have prospectively followed 90 sequential patients with newly developed foot ulcers from two major centers. One in the USA where the primary doctor was a podiatrist and one in Europe with a diabetologist. Thirty-four patients from Boston and 56 from Pisa (mean age, 55.6; range, 26-75 years; vs. 66.5; range, 35-94; P < 0.001), matched for sex, weight, type, duration of diabetes, renal impairment and retinopathy took part. Boston patients had more severe neuropathy, assessed with clinical examination utilizing a neuropathy disability score (NDS) (16 +/- 6 vs. 6 +/- 3 (mean +/- S.D.) P < 0.001) and vibration perception threshold (46 +/- 8 vs. 35 +/- 12 V: P < 0.001) while no difference existed in the number of patients with clinical infection, a history of lower extremity by-pass operation (6 (18%) vs. 3 (5%); P = NS) and in the size and the severity of the ulcer, according to the Wagner classification. Initial treatment was similar in both centers with emphasis on outpatient ulcer debridement, pressure relieving foot-wear and topical wound care. Hospitalization was needed in five (15%) Boston and 12 (21%) Pisa patients (P = NS) while surgery was performed on five (15%) Boston and 16 (29%) Pisa patients (P = NS). The in-hospital stay was similar in both centers (1.4 +/- 4.4 vs. 2.1 +/- 5.9 days; P = NS). The most common operations in both centers were incision, drainage and bone debridement. Ulcers healed in all patients but the amount of healing time was shorter in Boston patients (6.7 +/- 4.2 vs. 10.5 +/- 6.5 weeks; P < 0.02). We conclude that despite the differences in the two systems similar success rates were achieved in the two centers while a more surgically oriented strategy may have resulted in a slightly shorter healing time.

Longitudinal in-shoe foot pressure relief achieved by specially designed footwear in high risk diabetic patients.

Specially designed Thor-Lo footwear has been shown to reduce the in-shoe foot pressures in diabetic patients at risk of foot ulceration when compared to their own footwear. Fifty at high risk patients 32 (64%) males, 17 (34%) type 1 diabetes) have been provided with this foot wear and have been followed up for 6 months. Mean age was 57.6 (range, 34-78) years, duration of diabetes 22.4 (range, 4-50) years, Neuropathy Symptom Score 3.36 +/- 2.96 (mean +/- S.D.), Neuropathy Disability Score 16.8 +/- 6.83, VPT 43.4 +/- 11.8 Volts while 43 (86%) could not feel a 5.07 or smaller Semmes-Weinstein monofilament. Forty-two (84%) patients were re-examined at an interim visit 3 months after baseline, while 37 (74%) completed the study. In-shoe peak forces and pressures were measured using the F-Scan system. No difference was found among the peak force among baseline (95.5 +/- 26 kg), interim (96.5 +/- 33) and final visit (97.7 +/- 25.2, P + NS). There was no difference in peak pressures at the baseline (3.98 +/- 1.42 kg.cm-2), second visit (4.13 +/- 2.30) and the final visit (4.25 +/- 1.51). Nine (18%) patients developed foot problems and one died during the study. We conclude that no changes in foot pressures were found over a period of 6 months of continuous usage of the specially designed footwear in a group of diabetic patients at risk of foot ulceration. Further prospective studies are required to evaluate the impact of specially designed footwear in reducing the rate of foot ulceration.

Differences in joint mobility and foot pressures between black and white diabetic patients.

Limited joint mobility is common in diabetes and is related to high foot pressures and foot ulceration. We have examined the differences in joint mobility and foot pressures in four groups matched for age, sex, and duration of diabetes: 31 white diabetic, 33 white non-diabetic, 24 black diabetic, and 22 non-diabetic black subjects. Joint mobility was assessed using a goniometer at the fifth metacarpal, first metatarsal, and subtalar joints. In-shoe and without shoes foot pressures were measured using an F-Scan system. Neuropathy was evaluated using clinical symptoms (Neuropathy Symptom Score), signs (Neuropathy Disability Score), and Vibration Perception Threshold. There was no difference between white and black diabetic patients in Neuropathy Symptom Score, Neuropathy Disability Score, and Vibration Perception Threshold. Subtalar joint mobility was significantly reduced in white diabetic patients (22 +/- 7 degrees) compared to white controls (26 +/- 4 degrees, black diabetic patients (25 +/- 5 degrees), and black controls (29 +/- 7 degrees), and increased in black controls compared to white controls and black diabetic patients (level of statistical significance p < 0.05). Without shoes foot pressures were higher in white diabetic patients (8.31 +/- 400 kg cm-2) compared to white controls (6.81 +/- 2.31 kg cma2), black diabetic patients (6.2 +/- 2.53 kg cm-2) and black controls (5.00 +/- 1.24 kg cm-2) and lower in black controls compared to white and black diabetic patients (p < 0.05 in all cases). We conclude that racial differences exist in joint mobility and foot pressures between black and white subjects.(ABSTRACT TRUNCATED AT 250 WORDS)

Diabetic foot infections. Anatomy and surgery.

Sensory and motor neuropathy result in foot deformities highly susceptible to unrecognized trauma resulting in ulceration. Early, aggressive surgical debridement, adjunctive antibiotics, dressings, rest of the injured area, correction of ischemia, and control of diabetes are essential to prevent amputation.

Preventing loss of the great toe with the hallux interphalangeal joint arthroplasty.

Chronic ulcerations of the hallux may result in amputation if infection becomes uncontrolled. Salvage of the hallux often requires surgical intervention when conservative measures fail. Many authors have described various procedures to prevent recurrent ulceration and the potential for loss of the great toe. The authors have reviewed their experience with the hallux interphalangeal joint arthroplasty for chronic neuropathic ulcers of the great toe. Between August 1988 and July 1991, the authors performed 46 hallux interphalangeal joint arthroplasties on 40 patients (22 males, 18 females). Of the 40 original patients, one patient was lost to follow-up in the immediate postoperative period, leaving 45 procedures on 39 patients. Thirty-six feet were noted to heal both the procedure and ulceration uneventfully (80%). There were five minor complications (11%). Four cases were deemed failures (9%). Overall, 41 feet (91%) healed and had no evidence of recurrence in the follow-up period. Follow-up was an average of 23.6 months (range 4-44 months). The hallux interphalangeal joint arthroplasty has been a valuable procedure for chronic ulcerations of the hallux. By allowing these ulcers to heal, loss of the great toe has been avoided. Function and structure of the foot has been maintained.

In-shoe foot pressure measurements in diabetic patients with at-risk feet and in healthy subjects.

OBJECTIVE: To measure in-shoe foot pressures in diabetic patients and healthy subjects and compare them with the foot pressures when they walked without their shoes. RESEARCH DESIGN AND METHODS: Forty-four diabetic patients at risk of foot ulceration and 65 healthy subjects were matched for age, sex, race, and weight. Neuropathy was evaluated clinically, and the F-Scan program was used to measure the foot pressures. Foot pressures were measured with the sensors placed in the shoes (S measurements), between the foot and the sock with shoes (H measurements) or with their socks alone (B measurements). RESULTS: In the control group, significant differences were found between S (4.77 +/- 1.87 kg/cm2) and H measurements (5.12 +/- 1.87 kg/cm2, P < 0.001), between S and B (7.23 +/- 2.95 kg/cm2, P < 0.0001), and between H and B (P < 0.0001). In the diabetic group, no difference was found between S and H measurements (5.28 +/- 2.22 vs. 5.27 +/- 2.39 kg/cm2, NS). In contrast, the B pressure was significantly higher when compared with both (8.77 +/- 4.67 kg/cm2, P < 0.02). When compared with the control group, the S and H pressures did not differ significantly, but the B pressure in the diabetic group was significantly higher (P < 0.02). The peak S pressure was above the normal limit in 24 (27%) diabetic and 21 (16%) control feet (P < 0.05), the H pressure in 17 (19%) diabetic feet and 22 (17%) control feet (NS), and the B pressure in 24 (27%) diabetic and 21 (16%) control feet (P < 0.05). CONCLUSIONS: In-shoe foot pressure measurements are significantly lower than the ones measured when walking with the socks only in both diabetic patients and healthy subjects. The shoes of diabetic patients provided a higher pressure reduction than did those of the control group, but the number of feet with abnormally high pressures did not change. The F-Scan system may be particularly helpful in designing footwear suitable for diabetic patients with at-risk feet.

Maximizing foot salvage by a combined approach to foot ischemia and neuropathic ulceration in patients with diabetes. A 5-year experience.

OBJECTIVE: The combination of peripheral neuropathy and arterial insufficiency in patients with diabetes frequently results in chronic non-healing foot ulcers. These patients often have a protracted course that commonly ends in limb amputation. RESEARCH DESIGN AND METHODS: Since 1987, 39 diabetic patients presented with 42 neuropathic ulcerations beneath the lesser metatarsal heads, complicated by severe arterial insufficiency. A variety of vascular reconstructions were performed to improve circulation to the foot. After successful vascular reconstruction, 14 patients with deep ulcers underwent resection of the involved bone or joint through a plantar elliptical incision with excision of the ulcer and primary closure (33%). Five patients required a simultaneous panmetatarsal head resection (12%). For fifteen superficial ulcers, metatarsal osteotomy through a dorsal approach was performed (36%). Eight patients underwent a fifth metatarsal head resection through a dorsal approach (19%). RESULTS: In follow-up of 2-64 months (mean 21.2 months), 35 extremities with patent bypass grafts achieved and maintained primary healing of their local foot procedure (83%). Two feet required subsequent revision but ultimately healed (5%). Three feet (7%) developed a new plantar ulceration adjacent to the original one. In two extremities, the foot remained healed in spite of thrombosis of their grafts (5%). One patient with a thrombosed graft required a below-knee amputation. One patient died before the foot healed with a patent bypass graft. Overall, 40 of 42 extremities (95%) ultimately healed over the course of the follow-up period. CONCLUSIONS: We conclude that complex neuropathic ulcers in diabetic patients can be successfully treated by an aggressive surgical approach that removes infected bone and ulcers and corrects underlying structural abnormalities provided arterial insufficiency is corrected first.

Use of ampicillin/sulbactam versus imipenem/cilastatin in the treatment of limb-threatening foot infections in diabetic patients.

In a double-blind randomized trial, imipenem/cilastatin (I/C; 500 mg every 6 hours) and ampicillin/sulbactam (A/S; 3 g every 6 hours) were compared in regard to their efficacy for initial empirical and definitive parenteral treatment of limb-threatening pedal infection in diabetic patients. The major endpoints of treatment were cure (resolution of soft-tissue infection), failure (inadequate improvement, necessitating a change in antibiotic therapy), and eradication (clearance of all pathogens from the wound and any bone cultures). Patients in the two treatment groups were similar in regard to the severity of diabetes; presence of neuropathy and peripheral vascular disease; site and severity of infection; pathogen isolated; and frequency of osteomyelitis (associated with 68% of the 48 A/S-treated infections and 56% of the 48 I/C-treated infections). After 5 days of empirical treatment, improvement was noted in 94% of the A/S and 98% of the I/C recipients. At the end of definitive treatment (days' duration [mean +/- SD]: 13 +/- 6.5 [A/S], 14.8 +/- 8.6 [I/C]), outcomes were similar: cure, 81% (A/S) vs. 85% (I/C); failure, 17% (A/S) vs. 13% (I/C); and eradication, 67% (A/S) vs. 75% (I/C). Treatment failures were associated with the presence of antibiotic-resistant pathogens and possible nosocomial acquisition of infections. The number of adverse events among patients in the two treatment groups was similar: 7 in the A/S group (4 had diarrhea and 3 had rash) and 9 in the I/C group (5 had diarrhea, 2 had severe nausea, 1 had rash, and 1 had seizure). Efficacy of A/S and I/C is similar for initial empirical and definitive treatment of limb-threatening pedal infection in patients with diabetes.

Pedal leiomyoma.

Pedal leiomyoma has rarely been reported in the literature. The tumor has a predilection for middle-aged females, is often associated with pain, and usually lies subcutaneously within a well-defined capsule. The authors present the largest pedal leiomyoma in the English literature.

A historical look at the transmetatarsal amputation and its changing indications.

In March 1949, McKittrick described the use of the transmetatarsal amputation for the diabetic foot, along with specific indications. Infection, ischemia, and neuropathic ulcerations of the toes and forefoot were all treated with this procedure. In the past 30 years, however, advances in the management of these problems have led to a decrease in the number of transmetatarsal amputations performed at the New England Deaconess Hospital. With these advances, the current approach to the transmetatarsal amputation has changed, leading to significant modifications in the basic indications for this procedure.

Panmetatarsal head resection. A viable alternative to the transmetatarsal amputation.

While the transmetatarsal amputation has resulted in the salvage of numerous diabetic limbs, it remains an ablative procedure with both short- and long-term complications. The authors reviewed their experience with the panmetatarsal head resection as an alternative to the transmetatarsal amputation. A retrospective review was performed of all patients having undergone this procedure between May 1986 and November 1991. Thirty-seven procedures were performed; of these, 34 were evaluated. The average follow-up period was 20.9 months. Thirty-two feet showed primary healing while one showed delayed healing. One patient had local recurrence of the original ulceration. Primary healing was 94% while overall success was 97%. No patient required amputation of any kind. The authors conclude that the panmetatarsal head resection is a viable alternative to the transmetatarsal amputation in properly selected patients because it avoids many of the structural and biomechanical pitfalls of the transmetatarsal amputation.

Tendo Achillis procedures for chronic ulcerations in diabetic patients with transmetatarsal amputations.

Recurrent ulceration following transmetatarsal amputation commonly results from hypertrophic bone formation or equinus deformity. In the current study, 31 diabetic patients underwent 33 Achilles tendon procedures for recurrent ulcerations at the distal stump of their transmetatarsal amputation. Primary healing was achieved in 21 procedures (64%) and secondary healing in 9 procedures (27%) for an overall healing rate of 91%. Two procedures failed to resolve the original ulceration (6%). The average follow-up examination was 27 months. The authors conclude that Achilles tendon procedures are an effective means of managing ulcerations in transmetatarsal amputation feet exhibiting an equinus deformity.

Sesamoidectomy for the treatment of chronic neuropathic ulcerations.

Neuropathic ulcerations in diabetic patients are frequent causes of hospitalizations and morbidity. The plantar aspect of the first metatarsophalangeal joint is a common location for these ulcerations, because of the significant weightbearing forces generated through this joint and the presence of sensory and motor neuropathy. The authors describe 24 cases in which excision of the tibial sesamoid, fibular sesamoid, or both, was performed to resolve these lesions.

Charcot's disease in diabetic patients. Correct diagnosis can prevent progressive deformity.

Although Charcot's disease and its association with diabetes have been described many times in the literature, it is still often misdiagnosed and incorrectly treated as osteomyelitis, arthritis, or gout. The best safeguard is a high index of suspicion. A warm, swollen foot in a diabetic patient with long-standing neuropathy without local or systemic signs of infection must be considered Charcot's disease until proven otherwise. The principal treatment is total abstinence from putting weight on the foot until warmth, swelling, and redness subside. Protective weight-bearing methods may then be slowly instituted.

Review of metatarsal osteotomies for the treatment of neuropathic ulcerations.

The records of 52 patients who underwent metatarsal osteotomies for the treatment of chronic neuropathic ulcerations between the years 1983 and 1985 were analyzed in a retrospective study. Long-term follow-up information was available for all but three patients. All patients were conservatively managed preoperatively and postoperatively with shoes, accommodative orthoses, and local care. A limb salvage rate of 94%, 46 of 49 patients, was achieved in this study. Although 13 patients developed transfer ulcerations, all but one were managed either with conservative care or a lesser podiatric procedure, and all remain healed to date.