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

NCT00448903 | Completed Phase 3 DMC

• 2 other identifiers: ROV-BEM-2006-012006-005201-60
• Study Type: interventional
• Target: 329
• Locations: 6 countries
• Sites: 6

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

Keywords

diabetic; foot; ulcer; bemiparin; neuropathy; neuroishemic; diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• incidence of major bleeding and the incidence of adverse events.

  210 day

Study Arms (2)

A

EXPERIMENTAL

Bemiparin

Drug: Bemiparin

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Bemiparin DRUG

Bemiparin sodium

Also known as: RO-11, Hibor, Zibor, Ivor, Badyket, Ivorat, Ivormax, Entervit

A

Placebo DRUG

Sodium Chloride 0,9%

Also known as: Sodium Chloride, physiological saline

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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

You may not qualify if:

• 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 with a life expectancy less than 6 months.

Sponsors & Collaborators

• Rovi Pharmaceuticals Laboratories: lead

Study Sites (6)

CROATIA

Zagreb, Croatia

Location

POLAND

Warsaw, Poland

Location

ROMANIA

Timișoara, Romania

Location

RUSSIA

Saint Petersburg, Russia

Location

SERBIA

Belgrade, Serbia

Location

SPAIN

Madrid, Spain

Location

MeSH Terms

Conditions

Diabetic Foot; Ulcer; Diabetes Mellitus

Interventions

bemiparin; Ro 11; dexketoprofen trometamol; Sodium Chloride

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• JR March, MD

  Getafe Hospital, E-28905 Getafe (Madrid) Spain

  STUDY CHAIR

• J Marinel-lo, MD

  Mataró Hospital, E-08304 Mataro (Barcelona) Spain

  STUDY CHAIR

• R Gómez Medialdea, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 15, 2007
• First Posted: March 19, 2007
• Study Start: March 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: April 1, 2010
• Last Updated: March 17, 2011

Record last verified: 2010-05

Locations

RU (1); RO (1); CR (1); PL (1); SE (1); ES (1)