Abstract | AIMS: 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:
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Authors | M Rullan, L Cerdà, G Frontera, L Masmiquel, J Llobera |
Journal | Diabetic medicine : a journal of the British Diabetic Association
(Diabet Med)
Vol. 25
Issue 9
Pg. 1090-5
(Sep 2008)
ISSN: 1464-5491 [Electronic] England |
PMID | 19183313
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Fibrinolytic Agents
- Heparin, Low-Molecular-Weight
- bemiparin
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Diabetic Foot
(drug therapy)
- Female
- Fibrinolytic Agents
(therapeutic use)
- Heparin, Low-Molecular-Weight
(therapeutic use)
- Humans
- Male
- Middle Aged
- Statistics as Topic
- Treatment Outcome
- Wound Healing
(drug effects)
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