Treatment of chronic diabetic foot ulcers with bemiparin: a randomized, triple-blind, placebo-controlled, clinical trial.
OBJECTIVE
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 > 18 years, [corrected] 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 >or= 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.
Rullan
M
M
Pollença Primary Care Centre, Ib-Salut, Mallorca, Spain. mrullan@ibsalut.caib.es
Cerdà
L
L
Frontera
G
G
Masmiquel
L
L
Llobera
J
J
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017719:Diabetic Foot / Q000188:drug therapy*; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D006495:Heparin, Low-Molecular-Weight / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D013223:Statistics as Topic; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects*
D005343:Fibrinolytic Agents; D006495:Heparin, Low-Molecular-Weight; C411345:bemiparin