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Treatment of chronic diabetic foot ulcers with bemiparin: a randomized, triple‐blind, placebo‐controlled, clinical trial
Author(s) -
Rullan M.,
Cerdà L.,
Frontera G.,
Masmiquel L.,
Llobera J.
Publication year - 2008
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/j.1464-5491.2008.02527.x
Subject(s) - medicine , diabetic foot , placebo , randomized controlled trial , diabetes mellitus , clinical trial , foot (prosody) , double blind , endocrinology , alternative medicine , pathology , linguistics , philosophy
Abstract Aims To assess the efficacy and safety of bemiparin in the treatment of chronic diabetic foot ulcers. Methods A triple‐blind, parallel, randomized, placebo‐controlled trial. Patients aged > 8 years, with diabetes for at least 3 years, and with a foot ulcer persisting for > 3 months were selected from 39 Spanish centres. Bemiparin 3500 IU/day for 10 days, followed by 2500 IU/day for up to 3 months plus standard care for ulcers, was compared with placebo plus standard care for ulcers for 3 months. The primary efficacy end‐point was ulcer improvement, defined as an objective decrease in ulcer area of ≥ 50%, measured by digital photography and ImageJ software, and/or any decrease in Wagner's ulcer grade at 3 months. Results Ulcer improvement rates were 70.3% (26 of 37 patients) in the bemiparin group and 45.5% (15 of 33 patients) in the placebo group [absolute difference 24.8; 95% confidence interval (CI) 2.3, 47.3; P = 0.035] (number needed to treat 4; 95% CI 2, 43). Complete healing rates at 3 months were similar in both groups (35.1% vs. 33.3%; P = 0.874), as were the number of adverse events. Conclusions Bemiparin is more effective than placebo in the management of diabetic foot ulcers and has few side‐effects.