Efficacy of a Low-Molecular-Weight Heparin (Bemiparin) in the Treatment of Chronic Foot Ulcers in Diabetic Patients

• Status: Terminated
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the efficacy of bemiparin (low molecular weight heparin) for 3 months in the treatment of chronic foot ulcers in diabetic patients.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spanish National Health System
• Collaborators: Carlos III Health Institute; Rovi Pharmaceuticals Laboratories
• Treatments: Bemiparin; Calcium heparin; Dalteparin; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin

Criteria

Inclusion Criteria:

• age over 18 years;

• type I or II diabetes mellitus diagnosed (ADA 1998) for more than 3 years;

• presence of at least one cutaneous ulcer distal to the knee, not involving deep tissues (stages I and II of Wagner's classification ) and existing for at least three months;

• giving their written informed consent.

Exclusion Criteria:

• hypersensibility to heparin or pig derivatives

• body weight lower than 35 kg

• presence of clinical signs of infection that did not resolve in spite of oral antibiotics;

• anticoagulant therapy;

• severe impairment of renal or hepatic function;

• bleeding disorder;

• active peptic ulcer;

• arterial hypertension with poor control;

• pregnancy or lactation;

• terminal illness or a prognosis of survival under three months.