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

Foot Ulcer, Diabetic Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00399425
• Other study ID #: APM/00/PD1
• Secondary ID: AEM 01-0167
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: November 13, 2006
• Last updated: November 13, 2006
• Start date: June 2001
• Est. completion date: April 2004

Study information

• Verified date: November 2006
• Source: Spanish National Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Primary Health Care of Mallorca, IbsalutSpain: Spanish Agency of Medicines and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 84
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Angiopathies
• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic
• Ulcer

Intervention

Drug:
• bemiparin (low molecular weight heparin)

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Spanish National Health System	Carlos III Health Institute, Rovi Pharmaceuticals Laboratories

References & Publications (1)

Rullán M, Cerdà L, Frontera G, Llobera J, Masmiquel L, Olea JL. [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]. Aten Primaria. 2003 May 15;31(8):539-44. Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ulcer area
Primary	Stage in Wagner's classification
Secondary	Adverse effects
Secondary	Quality of life