Clinical trial NCT00448903: Clinical Trial to Evaluate the Efficacy and Safety of Sodium Bemiparin for Treatment of Diabetic Foot Ulcers
Official title: Multicentric, Randomized, Double-blind, Controlled Clinical Trial to Assess the Efficacy and Safety of Bemiparin Sodium as Treatment of Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Foot Ulcer, Diabetic
Keywords: diabetic
foot
ulcer
bemiparin
neuropathy
neuroishemic
diabetes
Lead sponsor: Rovi Pharmaceuticals Laboratories
Sponsor class: INDUSTRY
First posted: 2007-03-19
Enrollment: 329
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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.
timeFrame: 90 day
Secondary outcomes:
measure: incidence of major bleeding and the incidence of adverse events.
timeFrame: 210 day
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: CROATIA
city: Warsaw
country: Poland
facility: POLAND
city: Timisoara
country: Romania
facility: ROMANIA
city: St. Petersburg
country: Russian Federation
facility: RUSSIA
city: Belgrade
country: Serbia
facility: SERBIA
city: Madrid
country: Spain
facility: SPAIN
Study officials:
affiliation: Getafe Hospital, E-28905 Getafe (Madrid) Spain
name: JR March, MD
role: STUDY_CHAIR
affiliation: Mataró Hospital, E-08304 Mataro (Barcelona) Spain
name: J Marinel-lo, MD
role: STUDY_CHAIR
affiliation: Virgen de la Victoria Hospital, E-29010 Malaga, Spain
name: R Gómez Medialdea, MD
role: STUDY_CHAIR
References: