Status:
TERMINATED
Efficacy of a Low-Molecular-Weight Heparin (Bemiparin) in the Treatment of Chronic Foot Ulcers in Diabetic Patients
Lead Sponsor:
Spanish National Health System
Collaborating Sponsors:
Carlos III Health Institute
Rovi Pharmaceuticals Laboratories
Conditions:
Foot Ulcer, Diabetic
Diabetic Angiopathies
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
To assess the efficacy of bemiparin (low molecular weight heparin) for 3 months in the treatment of chronic foot ulcers in diabetic patients.
Detailed Description
The involvement of microcirculation in diabetes microangiopathy may be the cause of ulceration and severe incapacitation. Torpid ulcers of the lower limbs affect up to 15% of diabetic patients at some...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
End Date :
April 1 2004
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00399425
Start Date
June 1 2001
End Date
April 1 2004
Last Update
November 14 2006
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