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

Tracking Information
First Submitted Date ICMJE	November 13, 2006
First Posted Date ICMJE	November 14, 2006
Last Update Posted Date	November 14, 2006
Study Start Date ICMJE	June 2001
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: November 13, 2006)	Ulcer area; Stage in Wagner's classification
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: November 13, 2006)	Adverse effects; Quality of life
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Efficacy of a Low-Molecular-Weight Heparin (Bemiparin) in the Treatment of Chronic Foot Ulcers in Diabetic Patients
Official Title ICMJE	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 ICMJE	Interventional
Study Phase	Phase 2; Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
Condition ICMJE	Foot Ulcer, Diabetic; Diabetic Angiopathies
Intervention ICMJE	Drug: bemiparin (low molecular weight heparin)
Study Arms	Not Provided
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Enrollment ICMJE; (submitted: November 13, 2006)	84
Original Enrollment ICMJE	Same as current
Study Completion Date	April 2004
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00399425
Other Study ID Numbers ICMJE	APM/00/PD1; AEM 01-0167
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Spanish National Health System
Collaborators ICMJE	Carlos III Health Institute; Rovi Pharmaceuticals Laboratories
Investigators ICMJE	Principal Investigator: Manuel Rullan, MD Primary health care of Mallorca. Ibsalut.
PRS Account	Spanish National Health System
Verification Date	November 2006
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP