Foot Ulcer, DiabeticPhase 3NCT00448903
Clinical Trial to Evaluate the Efficacy and Safety of Sodium Bemiparin for Treatment of Diabetic Foot Ulcers
A Phase 3 study testing Bemiparin in people with Foot Ulcer, Diabetic, run by Rovi Pharmaceuticals Laboratories at 6 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Ulcer, Diabetic
- What is being tested?
- Bemiparin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 329 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Mar 2007to Apr 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: Multicentric, Randomized, Double-blind, Controlled Clinical Trial to Assess the Efficacy and Safety of Bemiparin Sodium as Treatment of Diabetic Foot Ulcers
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
- Being tested
- Bemiparin, Placebo
- Keywords
- diabetic, foot, ulcer, bemiparin, neuropathy, neuroishemic, diabetes
- Medical subject headings
- Diabetic Foot, Ulcer, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BemiparinDrug
Also called RO-11, Hibor, Zibor, Ivor
Bemiparin sodium
PlaceboDrug
Also called Sodium Chloride, physiological saline
Sodium Chloride 0,9%
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Bemiparin Receives: Drug: Bemiparin |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 day
Secondary outcomes (1)
incidence of major bleeding and the incidence of adverse events.
Measured: 210 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Ulcer, DiabeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rovi Pharmaceuticals Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- JR March, MD, Study chair, Getafe Hospital, E-28905 Getafe (Madrid) SpainJ Marinel-lo, MD, Study chair, Mataró Hospital, E-08304 Mataro (Barcelona) SpainR Gómez Medialdea, MD, Study chair, Virgen de la Victoria Hospital, E-29010 Malaga, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448903
- Sponsor's protocol ID
- ROV-BEM-2006-01
- Other IDs
- 2006-005201-60
- Status last verified
- May 2010
- First submitted
- 15 Mar 2007
- Last updated
- 17 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric, Randomized, Double-blind, Controlled Clinical Trial to Assess the Efficacy and Safety of Bemiparin Sodium as Treatment of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT00448903
- Acronym / sponsor ID
- ROV-BEM-2006-01
- Conditions
- Foot Ulcer, Diabetic
- Keywords
- diabetic, foot, ulcer, bemiparin, neuropathy, neuroishemic, diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Rovi Pharmaceuticals LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 19 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: BemiparinBemiparin |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BemiparinAlso: RO-11, Hibor, Zibor, IvorBemiparin sodium | Drug | A |
| PlaceboAlso: Sodium Chloride, physiological salineSodium Chloride 0,9% | Drug | 2 |
Primary outcome
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
1 secondary outcome
incidence of major bleeding and the incidence of adverse events.
Time frame: 210 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JR March, MD study chair
Getafe Hospital, E-28905 Getafe (Madrid) Spain
J Marinel-lo, MD study chair
Mataró Hospital, E-08304 Mataro (Barcelona) Spain
R Gómez Medialdea, MD study chair
Virgen de la Victoria Hospital, E-29010 Malaga, Spain
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bemiparin in people with Foot Ulcer, Diabetic, run by Rovi Pharmaceuticals Laboratories at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Croatia, Poland, Romania, Russia, Serbia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 90 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2011.