Treatment of chronic diabetic foot ulcers with bemiparin: a randomized, triple-blind, placebo-controlled, clinical trial
Treatment of chronic diabetic foot ulcers with bemiparin: a randomized, triple-blind, placebo-controlled, clinical trial
Accepted 12 June 2008
Published Online: 28 Jun 2008
M. Rullan, L. Cerdà, G. Frontera*, L. Masmiquel† and J. Llobera*
Diabetic Medicine
Wiley InterScience
Pollença Primary Care Centre, Ib-Salut, *Health Science Research University Institute (IUNICS), Illes Balears University, and Primary Care Research Unit and †Endocrinology Unit, Hospital Son Llàtzer Foundation, Son Ferriol, Mallorca, Spain
Correspondence to: M. Rullan, Pollença Primary Care Centre, C/Bisbe Desbach s/n, 07460 Pollença, Mallorca (Spain). E-mail: mrullan@ibsalut.caib.es
Copyright Journal compilation © 2008 Diabetes UK
KEYWORDS
bemiparin • diabetes • diabetic angiopathy • foot ulcer • heparin
Diabet. Med. 25, 1090–1095 (2008)
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.
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