Antonella Quarantiello

Adjunctive Systemic Hyperbaric Oxygen Therapy in Treatment of Severe Prevalently Ischemic Diabetic Foot Ulcer: A randomized study

OBJECTIVE To evaluate the effectiveness of systemic hyperbaric oxygen therapy (s HBOT) in addition to a comprehensive protocol in decreasing major amputation rate in diabetic patients hospitalized for severe foot ulcer. RESEARCH DESIGN AND METHODS From August 1993 to August 1995, 70 diabetic subjects were consecutively admitted into our diabetologic unit for foot ulcers. All the subjects underwent our diagnostic-therapeutic protocol and were randomized to undergo s-HBOT. Two subjects, one in the arm of the treated group and one in the arm of nontreated group, did not complete the protocol and were therefore excluded from the analysis of the results. Finally, 35 subjects received s-HBOT and another 33 did not. RESULTS Of the treated group (mean session = 38.8 ± 8), three subjects (8.6%) underwent major amputation: two below the knee and one above the knee. In the nontreated group, 11 subjects (33.3%) underwent major amputation: 7 below the knee and 4 above the knee. The difference is statistically significant (P = 0.016). The relative risk for the treated group was 0.26 (95% CI 0.08–0.84). The transcutaneous oxygen tension measured on the dorsum of the foot significantly increased in subjects treated with hyperbaric oxygen therapy: 14.0 ± 11.8 mmHg in treated group, 5.0 ± 5.4 mmHg in nontreated group (P = 0.0002). Multivariate analysis of major amputation on all the considered variables confirmed the protective role of s-HBOT (odds ratio 0.084, P = 0.033, 95% CI 0.008–0.821) and indicated as negative prognostic determinants low ankle-brachial index values (odds ratio 1.715, P = 0.013, 95% CI 1.121–2.626) and high Wagner grade (odds ratio 11.199, P = 0.022, 95% CI 1.406–89.146). CONCLUSIONS s-HBOT, in conjunction with an aggressive multidisciplinary therapeutic protocol, is effective in decreasing major amputations in diabetic patients with severe prevalently ischemic foot ulcers.

Manufactured Shoes in the Prevention of Diabetic Foot Ulcers

OBJECTIVE To evaluate the efficacy of manufactured shoes specially designed for diabetic patients (Podiabetes by Buratto Italy) to prevent relapses of foot ulcerations. RESEARCH DESIGN AND METHODS A prospective multicenter randomized follow-up study of patients with previous foot ulcerations was conducted. Patients were alternatively assigned to wear either their own shoes (control group, C; n = 36) or therapeutic shoes (Podiabetes group, P; n = 33). The number of ulcer relapses was recorded during 1-year follow-up. RESULTS Both C and P groups had similar risk factors for foot ulceration (i.e., previous foot ulceration, mean vibratory perception threshold > 25 mV). After 1 year, the foot ulcer relapses were significantly lower in P than in C (27.7 vs. 58.3%; P = 0.009; odds ratio 0.26 [0.2–1.54]). In a multiple regression analysis, the use of therapeutic shoes was negatively associated with foot ulcer relapses (coefficient of variation = −0.315; 95% confidence interval = −0.54 to −0.08; P = 0.009). CONCLUSIONS The use of specially designed shoes is effective in preventing relapses in diabetic patients with previous ulceration.

Angiographic evaluation of peripheral arterial occlusive disease and its role as a prognostic determinant for major amputation in diabetic subjects with foot ulcers

OBJECTIVE To evaluate in diabetic patients with foot ulcers the angiographic findings of peripheral occlusive arterial disease and their role as a prognostic determinant for major amputation. RESEARCH DESIGN AND METHODS From 1993 to 1995, 104 diabetic inpatients with foot ulcers underwent arteriography on the ulcerated limb. Stenoses in the iliac trunk, the superficial femoral artery, the profunda femoral artery, the popliteal artery, the anterior tibial artery, the posterior tibial artery, and the peroneal artery were scored on the basis of vessel lumen reduction: 0 if stenoses involved a reduction in the vessel lumen of <50%, 1 if stenoses involved 50 to <75% reduction, 2 if stenoses involved 75 to <100% reduction, and 3 if total occlusion was present. The sum of the points assigned to each of these arteries was called the angiographic score. RESULTS Stenoses causing a vessel lumen reduction ≥50% were detected in 103 patients (99%). Stenoses were also detected in subjects with palpable foot pulses, ankle-brachial indexes ≥1, or transcutaneous oxygen tension ≥50 mmHg. The risk of major amputation was increased significantly when total occlusion was present in the popliteal and infrapopliteal arteries (x2 for trend = 50.57, P < 0.001). No major amputation was carried out in patients with angiographic scores <10; major amputation was carried out in all the patients with scores >14. Multivariate analysis indicated a high angiographic score as an independent risk factor for major amputation (odds ratio 2.32, P = 0.001, CI 1.40–3.84). CONCLUSIONS Angiography permits an exact detection of occlusive arterial disease in subjects with normal results for noninvasive vascular procedures. A score that has a relevant prognostic value for major amputation can be obtained from the evaluation of the extent and diffusion of the stenoses.

Long-Term Prognosis of Diabetic Patients With Critical Limb Ischemia: A population-based cohort study

OBJECTIVE To evaluate the long-term prognosis of critical limb ischemia (CLI) in diabetic patients. RESEARCH DESIGN AND METHODS A total of 564 consecutive diabetic patients were hospitalized for CLI from January 1999 to December 2003; 554 were followed until December 2007. RESULTS The mean follow-up was 5.93 ± 1.28 years. Peripheral angioplasty (PTA) was performed in 420 (74.5%) and bypass graft (BPG) in 117 (20.6%) patients. Neither PTA nor BPG were possible in 27 (4.9%) patients. Major amputations were performed in 74 (13.4%) patients: 34 (8.2%) in PTA, 24 (21.1%) in BPG, and 16 (59.2%) in a group that received no revascularization. Restenosis occurred in 94 patients, bypass failures in 36 patients, and recurrent ulcers in 71 patients. CLI was observed in the contralateral limb of 225 (39.9%) patients; of these, 15 (6.7%) required major amputations (rate in contralateral compared with initial limb, P = 0.007). At total of 276 (49.82%) patients died. The Cox model showed significant hazard ratios (HRs) for mortality with age (1.05 for 1 year [95% CI 1.03–1.07]), unfeasible revascularization (3.06 [1.40–6.70]), dialysis (3.00 [1.63–5.53]), cardiac disease history (1.37 [1.05–1.79]), and impaired ejection fraction (1.08 for 1% point [1.05–1.09]). CONCLUSIONS Diabetic patients with CLI have high risks of amputation and death. In a dedicated diabetic foot center, the major amputation, ulcer recurrence, and major contralateral limb amputation rates were low. Coronary artery disease (CAD) is the leading cause of death, and in patients with CAD history the impaired ejection fraction is the major independent prognostic factor.

Change in Major Amputation Rate in a Center Dedicated to Diabetic Foot Care During the 1980s: Prognostic Determinants for Major Amputation

From 1990 to 1993, 115 diabetic patients were consecutively hospitalized in our diabetologic unit for foot ulcer and 27 (23.5%) major amputations were carried out. The major amputation rate of this series of cases was compared with that occurring in diabetic subjects taken into our hospital for foot ulcer in two previous periods: 1979-1981 (17 major amputations in 42 inpatients or 40.5%) and 1986-1989 (26 major amputations in 78 inpatients or 33.3%). The comparison shows a progressive reduction in major amputation rate [Odds ratio 0.66, 95% confidence interval (CI) 0.46-0.96]. Univariate and multivariate analysis, carried out in the population of the 1990-1993 period, in order to detect the independent factors associated with major amputation show the following prognostic determinants of major amputation: Wagner grade (odds ratio 7.69, CI 1.58-37.53), prior stroke (odds ratio 35.05, CI 3.14-390.53), prior major amputation (odds ratio 3.49, CI 1.26-9.38), transcutaneous oxygen level (odds ratio 1.06, CI 1.01-1.12), and ankle-brachial blood pressure index (odds ratio 4.35, CI 1.58-12.05), while an independent protective role was attributed to hyperbaric oxygen treatment (odds ratio 0.15, CI 0.03-0.64). In accordance with other studies, we, therefore, conclude that a comprehensive protocol as well as a multidisciplinary approach in a dedicated center can assure a decrease in major amputation rate. The parameters of limb perfusion were the modifiable prognostic determinants most strongly predictive for amputation.

When is a technically successful peripheral angioplasty effective in preventing above-the-ankle amputation in diabetic patients with critical limb ischaemia?

Aim  To determine parameters predictive of avoidance of major (above‐the‐ankle) amputation after a technically successful peripheral angioplasty (PTA) in patients with diabetes with critical limb ischaemia.

The use of a dermal substitute to preserve maximal foot length in diabetic foot wounds with tendon and bone exposure following urgent surgical debridement for acute infection

In this study, we evaluated the utility of a dermal substitute for preserving maximal foot length after urgent surgical debridement. Patients referred to our Diabetic Foot Center with foot lesions were assessed for sensory–motor neuropathy, infection and critical limb ischaemia. The presence of acute foot infection indicated the need for immediate surgical debridement. The degree of amputation, if necessary, was based on the amount of apparently non infected vital tissue. When vital tendon/bone tissue remained exposed, the lesion was covered with a dermal substitute. From January to December 2008, 393 patients underwent surgical treatment for diabetic foot syndrome; 30 patients underwent immediate surgical debridement resulting in exposed tendon and/or bone tissues. An average of 4·4 ± 2·1 days following surgical debridement, all 30 patients underwent dermal regeneration template grafting to cover‐exposed healthy tendon and bone tissues, instead of achieving primary wound closure with a proximal amputation. After 21 days, a skin graft was performed. Complete wound healing occurred in 26 patients (86·7%). In these patients, the amputation level was significantly more distal (P < 0·003) with respect to that potentially required for immediate wound closure. The average healing time was 74·1 ± 28·9 days. Four patients underwent a more proximal amputation. No patients underwent major amputation. The use of the dermal substitute for treating exposed tendon and bone tissues allowed timely wound healing and preserved maximal foot length. Continued follow‐up will allow assessment of long‐term relapse and complication rates. Such treatment could constitute part of the comprehensive management of diabetic wounds.

The Use of a Dermal Substitute (Integra) to Preserve Maximal Foot Length in a Diabetic Foot Wound With Bone and Tendon Exposure Following Urgent Surgical Debridement for an Acute Infection

In this report, the authors present the case of a 62-year-old female patient who was admitted to our hospital with an acute deep foot infection. The patient was taken immediately to the operating room where she underwent surgical debridement to completely remove all infected tissues; at the end of this first surgical step, all 5 metatarsal bones remained exposed dorsally. Once eradication of infection was completed, we had to decide whether to perform a transmetatarsal amputation at proximal levels, which would have allowed healing by first intention but would have left the patient with a smaller foot stump, or amputation at more distal levels followed by coverage of healthy tendon and bone tissues with a dermal regeneration template (Integra, Integra Life Sciences Corporation, Plainsboro, NJ), which would have preserved the foot stump length and allowed better walking. We opted for the second choice, and the use of a dermal template actually enabled our patient to maintain a considerable foot stump length, much longer than would have resulted from an amputation with immediate primary closure.

Advantages of myocardial revascularization after admission for critical limb ischemia in diabetic patients with coronary artery disease: Data of a cohort of 564 consecutive patients

Aim To evaluate the survival benefit from myocardial revascularization in diabetic patients with critical limb ischemia and coronary artery disease (CAD) in a consecutive series of 564 diabetic patients hospitalized from 1999 to 2003 and followed up until December 2005. Methods Three hundred and thirteen patients had a history of CAD, 60 of them (19.2%) with previous myocardial revascularization. Sixty-one patients with an ejection fraction of 40% or less underwent subsequent myocardial revascularization. Five hundred and fifty-seven patients (98.8%) were followed up until December 2005, including 310 of the 313 patients with a history of CAD. Results One hundred and ten patients died because of CAD, 25 of the 251 patients without a history of CAD and 85 of the 313 patients with a history of CAD. Specifically, 74 (86.9%) of these 85 deaths occurred in the 192 patients without previous myocardial revascularization, nine (10.7%) in the 60 patients with previous myocardial revascularization, and two (2.4%) in the 61 patients in whom myocardial revascularization was performed after hospital admission for critical limb ischemia. The Cox model showed significant hazard ratio for mortality associated with age [hazard ratio 1.06 for 1 year, P = 0.003, confidence interval (CI) 1.02–1.09], history of CAD (hazard ratio 2.16, P < 0.001, CI 1.53–3.06), dialysis (hazard ratio 3.52, P < 0.001, CI 2.08–5.97), and impaired ejection fraction (hazard ratio 1.08 for one point percentage, P < 0.001, CI 1.05–1.09). Myocardial revascularization appeared to have a protective role: hazard ratio 0.29, P < 0.001, CI 0.33–0.93. Conclusion Paying attention to CAD in diabetic patients during their hospitalization for critical limb ischemia is useful for a subsequent myocardial revascularization, and it may increase survival in these patients.

Kaposi's sarcoma misdiagnosed as a diabetic plantar foot ulcer.

In this report, the authors describe the case of a patient with Kaposis sarcoma that was initially misdiagnosed as a plantar ulcer. The ulcer typically appeared as a neuropathic foot ulceration located on the plantar aspect of the first metatarsal head. There was hyperkeratosis on the plantar surfaces of the other metatarsal heads. However, the lesion had mushrooming granulation tissue, without undermined perilesional edges. A wound biopsy revealed the presence of Kaposis sarcoma. The presence of cancerous lesions on the plantar aspect of the foot is an infrequent event in diabetic patients. However, given the malignant nature of some skin cancers careful clinical examination and biopsy of the wound are advisable.