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

Foot Ulcer, Diabetic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448903
• Other study ID #: ROV-BEM-2006-01
• Secondary ID: 2006-005201-60
• Status: Completed
• Phase: Phase 3
• First received: March 15, 2007
• Last updated: March 16, 2011
• Start date: March 2007
• Est. completion date: April 2010

Study information

• Verified date: May 2010
• Source: Rovi Pharmaceuticals Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 329
• Est. completion date: April 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Bemiparin
Bemiparin sodium
• Placebo
Sodium Chloride 0,9%

Locations

Country	Name	City	State
Croatia	CROATIA	Zagreb
Poland	POLAND	Warsaw
Romania	ROMANIA	Timisoara
Russian Federation	RUSSIA	St. Petersburg
Serbia	SERBIA	Belgrade
Spain	SPAIN	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Rovi Pharmaceuticals Laboratories

Countries where clinical trial is conducted

Croatia,  Poland,  Romania,  Russian Federation,  Serbia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		90 day	No
Secondary	incidence of major bleeding and the incidence of adverse events.		210 day	Yes