Status:
COMPLETED
Clinical Trial to Evaluate the Efficacy and Safety of Sodium Bemiparin for Treatment of Diabetic Foot Ulcers
Lead Sponsor:
Rovi Pharmaceuticals Laboratories
Conditions:
Foot Ulcer, Diabetic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
329 Patients enrolled
Trial Details
Trial ID
NCT00448903
Start Date
March 1 2007
End Date
April 1 2010
Last Update
March 17 2011
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
CROATIA
Zagreb, Croatia
2
POLAND
Warsaw, Poland
3
ROMANIA
Timișoara, Romania
4
RUSSIA
Saint Petersburg, Russia