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 oxyge n therapy (s-HBOT) in addition to a comprehensive protocol in decreasi ng major amputation rate in diabetic patients hospitalized for severe foot ulcer. RESEARCH DESIGN AND METHODS - From August 1993 to August 1 995, 70 diabetic subjects were consecutively admitted into our diabeto logic unit for foot ulcers. All the subjects underwent our diagnostic- therapeutic protocol and were randomized to undergo s-HBOT. Two subjec ts, one in the arm of the treated group and one in the arm of nontreat ed group, did not complete the protocol and were therefore excluded fr om the analysis of the results. Finally, 35 subjects received s-HBOT a nd another 33 did not. RESULTS - Of the treated group (mean session = 38.8 +/- 8), three subjects (8.6%) underwent major amputation: two bel ow the knee and one above the knee. In the nontreated group, 11 subjec ts (33.3%) underwent major amputation: 7 below the knee and 4 above th e knee. The difference is statistically significant (P = 0.016). The r elative risk for the treated group mas 0.26 (95% CI 0.08-0.84). The tr anscutaneous oxygen tension measured on the dorsum of the foot signifi cantly increased in subjects treated with hyperbaric oxygen therapy: 1 4.0 +/- 11.8 mmHg in treated group, 5.0 +/- 5.4 mmHg in nontreated gro up (P = 0.0002). Multivariate analysis of major amputation on all the considered variables confirmed the protective role of s-HBOT (odds rat io 0.084, P = 0.033, 95% CI 0.008-0.821) and indicated as negative pro gnostic 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 conjunc tion with an aggressive multidisciplinary therapeutic protocol, is eff ective in decreasing major amputations in diabetic patients with Sever e prevalently ischemic foot ulcers.