Clinical Trial to Evaluate the Efficacy and Safety of Sodium Bemiparin for Treatment of Diabetic Foot Ulcers

March 16, 2011 updated by: Rovi Pharmaceuticals Laboratories

Multicentric, Randomized, Double-blind, Controlled Clinical Trial to Assess the Efficacy and Safety of Bemiparin Sodium as Treatment of Diabetic Foot Ulcers

Chronic foot ulcers are a common, severe and expensive complication in patients with diabetes and often causes lower-extremity amputation. The aim of this study is to evaluate the effect of bemiparin as treatment of diabetic foot ulcers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

329

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients over 18 years old who have given their informed consent to participate in the study.
  • Patients with type I or II Diabetes Mellitus (ADA Criteria).
  • Presence of chronic neuropathic inframalleolar diabetic foot ulcer (starting at least 2 months before), grade I or II on Wagner Classification, without significant improvement (reduction of ulcer area > or = 25%) within the past 15 days prior to inclusion.
  • Ulcer size equal or bigger than 0.64 cm2 using the following formula: [Major axis] x [Minor axis]
  • Ankle-brachial index (ABI) > or = 0,7

Exclusion Criteria:

  • Patients with clinical symptoms of limb-threatening or life-threatening infection
  • Presence of bone exposure at the bottom of the ulcer and/or bone palpation by catheter and/or presence of radiological signs of pathological fractures and/or bone sequesters
  • Ankle-brachial index (ABI) <0,7
  • Subjects with arterial calcification (ABI > 1,3) with negative tibial and foot pulse that for any cause the Toe/Arm index (T/A) cannot be measured by plethysmography (photoplethysmography or strain-gauge)
  • Subjects with arterial calcification (ABI > 1,3) with negative tibial and foot pulse and with T/A index < 0,55 measured by plethysmography (photoplethysmography or strain-gauge)
  • Patients with hematological disorders, organic lesions susceptible to bleeding (e.g. active peptic ulcer, stroke, aneurysms), severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure over 120 mmHg).
  • Patients with severe renal failure (creatinine clearance <30 ml/min) or hepatic insufficiency (AST and/or ALT values >5 times the normal value established by the reference ranges of the local hospital laboratory).
  • Patients with connective tissue disease
  • Acute bacterial endocarditis or slow endocarditis.
  • Patients with antithrombin deficit and C and S protein deficit.
  • Patients with HbA1C > 12%.
  • Women who are pregnant or breast-feeding, or with the possibility of becoming pregnant during the study.
  • Known hypersensitivity to LMWH, heparin or substances of porcine origin.
  • Patients with a history of heparin-induced thrombocytopenia.
  • Patients on treatment with anticoagulant therapy at inclusion time or in the past 15 days.
  • Patients on treatment with pentoxifiline at inclusion time or in the past 30 days.
  • Patients on treatment with systemic corticosteroid or immunosuppressive therapy at inclusion time or in the past 3 months.
  • Patients on treatment with beclapermin at inclusion time or in the past 15 days.
  • Patients that have suffered a revascularization or endovascular surgery two months prior to inclusion
  • Patients with a life expectancy less than 6 months.
  • Patients that cannot complete the scheduled follow-up visits or are not able to complete the study period.
  • Patients who are participating in another clinical trial or have done it in the past 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: Placebo
Sodium Chloride 0,9%
Other Names:
  • Sodium Chloride
  • physiological saline
Experimental: A
Bemiparin
Drug: Bemiparin
Bemiparin sodium
Other Names:
  • Hibor
  • RO-11
  • Zibor
  • Ivor
  • Badyket
  • Ivorat
  • Ivormax
  • Entervit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
total healing with intact skin or a significant improvement defined as a reduction of ulcer area > or = 50% or one degree reduction on Wagner Classification.
Time Frame: 90 day
90 day

Secondary Outcome Measures

Outcome Measure
Time Frame
incidence of major bleeding and the incidence of adverse events.
Time Frame: 210 day
210 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rovi Pharmaceuticals Laboratories

Investigators

  • Study Chair: JR March, MD, Getafe Hospital, E-28905 Getafe (Madrid) Spain
  • Study Chair: J Marinel-lo, MD, Mataró Hospital, E-08304 Mataro (Barcelona) Spain
  • Study Chair: R Gómez Medialdea, MD, Virgen de la Victoria Hospital, E-29010 Malaga, Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

March 15, 2007

First Submitted That Met QC Criteria

March 16, 2007

First Posted (Estimate)

March 19, 2007

Study Record Updates

Last Update Posted (Estimate)

March 17, 2011

Last Update Submitted That Met QC Criteria

March 16, 2011

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROV-BEM-2006-01
  • 2006-005201-60

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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