Efficacy of a Low-Molecular-Weight Heparin (Bemiparin) in the Treatment of Chronic Foot Ulcers in Diabetic Patients
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Purpose
To assess the efficacy of bemiparin (low molecular weight heparin) for 3 months in the treatment of chronic foot ulcers in diabetic patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Foot Ulcer, Diabetic Diabetic Angiopathies |
Drug: bemiparin (low molecular weight heparin) |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Triple-Blind Clinical Trial With Placebo Control to Evaluate the Efficacy of a Heparin of Low Molecular Weight (Bemiparin) for Treating Slow-Responding Ulcers in Diabetic Foot in Primary Care |
- Ulcer area
- Stage in Wagner's classification
- Adverse effects
- Quality of life
| Estimated Enrollment: | 84 |
| Study Start Date: | June 2001 |
| Estimated Study Completion Date: | April 2004 |
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 moment of their lifetime; about one-third of patients developing ulcers will never achieve their definitive cure, and half of them will die within three years .
Heparins, besides their well known antithrombotic effects, have been shown to stimulate both the synthesis of heparan sulphate —a potent endogenous anticoagulant— in endothelial cell cultures and the proliferation of fibroblasts taken from diabetic ulcers .
After noticing the highly positive evolution of chronic ulcers in six diabetic patients who had received LMWHs in their homes for the prophylaxis of deep vein thrombosis , and considering the excellent safety record of these drugs, we decided to explore the effects of LMWHs on the evolution of diabetic foot ulcers and the quality of life of diabetic patients seen in our primary care practices.
Comparison: bemiparin vs placebo
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00399425 History of Changes |
| Other Study ID Numbers: | APM/00/PD1, AEM 01-0167 |
| Study First Received: | November 13, 2006 |
| Last Updated: | November 13, 2006 |
| Health Authority: | Spain: Primary Health Care of Mallorca, Ibsalut Spain: Spanish Agency of Medicines and Medical Devices |
Keywords provided by Spanish National Health System:
|
Heparin, Low-Molecular-Weight Bemiparin Foot Ulcer, Diabetic Diabetic Angiopathies Primary Health Care |
Additional relevant MeSH terms:
|
Diabetic Angiopathies Ulcer Foot Ulcer Diabetic Foot Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Pathologic Processes Foot Diseases Skin Diseases Leg Ulcer Skin Ulcer |
Diabetic Neuropathies Calcium heparin Heparin Heparin, Low-Molecular-Weight Dalteparin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 18, 2013