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

• ClinicalTrials.gov Identifier: NCT00399425
• Recruitment Status: Terminated
• First Posted: November 14, 2006
• Last Update Posted: November 14, 2006
• Sponsor: Spanish National Health System
• Collaborators: Carlos III Health Institute; Rovi Pharmaceuticals Laboratories
• Information provided by: Spanish National Health System

Tracking Information

• First Submitted Date: November 13, 2006
• First Posted Date: November 14, 2006
• Last Update Posted Date: November 14, 2006
• Study Start Date: June 2001
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: November 13, 2006)

• Ulcer area
• Stage in Wagner's classification

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: November 13, 2006)

• Adverse effects
• Quality of life

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment

Condition

• Foot Ulcer, Diabetic
• Diabetic Angiopathies

• Intervention: Drug: bemiparin (low molecular weight heparin)
• Study Arms: Not Provided
• Publications *: Rullan M, Cerda 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. doi: 10.1016/s0212-6567(03)70729-x. Spanish.

Recruitment Information

• Recruitment Status: Terminated
• Enrollment (submitted: November 13, 2006): 84
• Original Enrollment: Same as current
• Study Completion Date: April 2004
• Primary Completion Date: Not Provided

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00399425
• Other Study ID Numbers: APM/00/PD1; AEM 01-0167
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Spanish National Health System
• Original Study Sponsor: Same as current

Collaborators

• Carlos III Health Institute
• Rovi Pharmaceuticals Laboratories

Investigators

• Principal Investigator: Manuel Rullan, MD; Primary health care of Mallorca. Ibsalut.

• PRS Account: Spanish National Health System
• Verification Date: November 2006