Clinical Trial to Evaluate the Efficacy and Safety of Sodium Bemiparin for Treatment of Diabetic Foot Ulcers
This study has been completed.
Information provided by:
Rovi Pharmaceuticals Laboratories
First received: March 15, 2007
Last updated: March 16, 2011
Last verified: May 2010
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.
Foot Ulcer, Diabetic
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Multicentric, Randomized, Double-blind, Controlled Clinical Trial to Assess the Efficacy and Safety of Bemiparin Sodium as Treatment of Diabetic Foot Ulcers
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- incidence of major bleeding and the incidence of adverse events. [ Time Frame: 210 day ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2009 (Final data collection date for primary outcome measure)
Placebo Comparator: 2
Sodium Chloride 0,9%
- Sodium Chloride
- physiological saline
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00448903
|Zagreb, Croatia |
|Warsaw, Poland |
|Timisoara, Romania |
|St. Petersburg, Russian Federation |
|Belgrade, Serbia |
|Madrid, Spain |
Rovi Pharmaceuticals Laboratories
||JR March, MD
||Getafe Hospital, E-28905 Getafe (Madrid) Spain
||J Marinel-lo, MD
||Mataró Hospital, E-08304 Mataro (Barcelona) Spain
||R Gómez Medialdea, MD
||Virgen de la Victoria Hospital, E-29010 Malaga, Spain
No publications provided
||Rovi Pharmaceuticals Laboratories, Medical Department
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 15, 2007
||March 16, 2011
||Spain: Spanish Agency of Medicines
Keywords provided by Rovi Pharmaceuticals Laboratories:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 02, 2015
Endocrine System Diseases