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

NCT ID: NCT00448903

Last Updated: 2011-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 329 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2010-04-30

Brief Summary

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.

Conditions

Foot Ulcer, Diabetic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

A

Bemiparin

Group Type: EXPERIMENTAL

Bemiparin

Intervention Type: DRUG

Bemiparin sodium

2

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Sodium Chloride 0,9%

Interventions

Bemiparin

Bemiparin sodium

Intervention Type: DRUG

Placebo

Sodium Chloride 0,9%

Intervention Type: DRUG

Other Intervention Names

RO-11; Hibor; Zibor; Ivor; Badyket; Ivorat; Ivormax; Entervit; Sodium Chloride; physiological saline

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rovi Pharmaceuticals Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Medical Department

Principal Investigators

JR March, MD

Role: STUDY_CHAIR

Getafe Hospital, E-28905 Getafe (Madrid) Spain

J Marinel-lo, MD

Role: STUDY_CHAIR

Mataró Hospital, E-08304 Mataro (Barcelona) Spain

R Gómez Medialdea, MD

Role: STUDY_CHAIR

Virgen de la Victoria Hospital, E-29010 Malaga, Spain

Locations

CROATIA

Zagreb, , Croatia

POLAND

Warsaw, , Poland

ROMANIA

Timișoara, , Romania

RUSSIA

Saint Petersburg, , Russia

SERBIA

Belgrade, , Serbia

SPAIN

Madrid, , Spain

Countries

Croatia; Poland; Romania; Russia; Serbia; Spain

Other Identifiers

2006-005201-60

Identifier Type: -

Identifier Source: secondary_id

ROV-BEM-2006-01

Identifier Type: -

Identifier Source: org_study_id