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.

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 > or = 50% were detected in 103 patients (99%). Stenoses were also detected in subjects with palpable foot pulses, ankle-brachial indexes > or = 1, or transcutaneous oxygen tension > or = 50 mmHg. The risk of major amputation was increased significantly when total occlusion was present in the popliteal and infrapopliteal arteries (chi 2 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.

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.

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.

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.

Comparison of two intensified conventional insulin regimens with three and four daily injections.

When choosing an intensified conventional insulin therapy, no specific differentiation is made between the three-injection regimen (regular insulin at breakfast and lunch, and regular+intermediate-acting insulin at dinner) and the four-injection regimen (regular insulin at breakfast, lunch and dinner, and intermediate-acting insulin at bedtime). No published studies have evaluated to our knowledge the differences between these two regimens. In 1991, we proposed to 30 stable type 1 diabetic patients without residual insulin secretion a change from three to four daily injections: 7 refused, 4 were later excluded for intercurrent events; 19 followed the four daily injection regimen for 2 years. In these non randomized 19 patients, the Student's test for paired data was used to compare with a self-controlled study the 1989-90 three-daily injection period with the 1991-92 four-daily-injection period in order to evaluate any differences in daytime blood glucose values (bi-monthly out-patient measurements taken at 8 am, 10 am, 3 pm and 5 pm), nocturnal blood glucose levels at 3 am (bi-monthly patient self-monitoring by means of a blood glucose meter, for a total of 188 vs 188 measurements), HbA1c (a total of 203 vs 207 bi-monthly out-patient measurements), the number of nocturnal hypoglycaemic attacks, body weight and mean insulin requirement.(ABSTRACT TRUNCATED AT 250 WORDS)