Fabrizio Favales

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.

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.

Feasibility and Effectiveness of Peripheral Percutaneous Transluminal Balloon Angioplasty in Diabetic Subjects With Foot Ulcers

OBJECTIVE The aim of this study was to evaluate the feasibility and effectiveness of this vascular procedure in diabetic inpatients with foot ulcers. RESEARCH DESIGN AND METHODS In 80 consecutive inpatient diabetic subjects with a foot ulcer, an angiographic study of the lower limbs was carried out to evaluate the necessity and possibility of performing vascular procedures. In 22 subjects, vascular procedure was not necessary; in 26 subjects, peripheral transluminal angioplasty was carried out; in 10 subjects, angioplasty was considered impossible and a peripheral bypass graft was performed; and in 22 subjects, no vascular procedure was considered possible. RESULTS Of the 26 angioplasties, 8 were performed in iliac or femoral arteries and 18 were performed in the popliteal artery and its branches. The angioplasty was considered unsuccessful in 4 subjects and successful in 22. After angioplasty, on discharge, parameters of limb perfusion improved significantly: transcutaneous oxygen tension was 27.0 ± 14 mm/Hg on admission and 44.6 ± 14 mm/Hg on discharge (P < 0.001); ankle-brachial index was 0.61 ± 0.23 on admission and 0.77 ± 0.20 on discharge (P = 0.018). Of 22 subjects who underwent successful angioplasty, 21 ended the follow-up of 12 months: during this period, they showed no relapses in the salvaged limb, and their parameters of limb perfusion did not significantly vary. CONCLUSIONS Angioplasty is feasible in a large percentage of diabetic subjects with peripheral occlusive arterial disease and foot ulcer and is often also practicable in the popliteal artery and its branches. In these subjects, angioplasty significantly improves the parameters of limb perfusion. Angioplasty is therefore an important therapeutic tool in ulcerated diabetic foot care.

Effect of Amlodipine on Insulin Secretion, Glucose, Lipid Profile and Urinary Albumin Excretion in Patients with Mild Hypertension and Non-Insulin-Dependent Diabetes

SummaryThe effects of amlodipine 5 to 10 mg/day on hypertension and metabolic indices was assessed in 113 patients with recently diagnosed untreated mild hypertension, and non-insulin-dependent diabetes mellitus (NIDDM). Comparisons were made with normotensive patients matched with similar demographic and clinical characteristics.Amlodipine showed notable antihypertensive efficacy without affecting heart rate. It had no negative effect on glucose homeostasis (HbA1c and blood glucose levels), β-cell secretion or serum lipid profile, although lipoprotein A levels increased. No progression of ocular or cardiac disease was noted during treatment with the drug, indicating a possible protective effect. Eight of 82 (9.7%) treated hypertensive patients and 6 of 78 (7.7%) normotensive patients with normal urinary albumin excretion rates (AER) at baseline developed microalbuminuria after 52 weeks. No patient with microalbuminuria developed proteinuria. Opposing significant intergroup differences in AER were noted for normotensive (increased; p < 0.05) and hypertensive (decreased; not significant) patients with baseline microalbuminuria. Together, these results suggest a renoprotective role for amlodipine in this setting.In conclusion, amlodipine is an effective antihypertensive agent that has no negative long term effect on glucose homeostasis, β-cell secretion or lipid profile in patients with mild hypertension and NIDDM.