Foot Ulcer, DiabeticPhase 2/3NCT00399425
Efficacy of a Low-Molecular-Weight Heparin (Bemiparin) in the Treatment of Chronic Foot Ulcers in Diabetic Patients
A Phase 2/3 study testing bemiparin (low molecular weight heparin) in people with Foot Ulcer, Diabetic and Diabetic Angiopathies, run by Spanish National Health System.
Trial summary
To assess the efficacy of bemiparin (low molecular weight heparin) for 3 months in the treatment of chronic foot ulcers in diabetic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Ulcer, Diabetic, Diabetic Angiopathies
- What is being tested?
- bemiparin (low molecular weight heparin)
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Jun 2001to Apr 2004
- Phase
- Phase 2/3
- 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
- age over 18 years;
- type I or II diabetes mellitus diagnosed (ADA 1998) for more than 3 years;
- presence of at least one cutaneous ulcer distal to the knee, not involving deep tissues (stages I and II of Wagner's classification ) and existing for at least three months;
- giving their written informed consent.
Who cannot join
- hypersensibility to heparin or pig derivatives
- body weight lower than 35 kg
- presence of clinical signs of infection that did not resolve in spite of oral antibiotics;
- anticoagulant therapy;
- severe impairment of renal or hepatic function;
- bleeding disorder;
Show all 10Show fewer
- active peptic ulcer;
- arterial hypertension with poor control;
- pregnancy or lactation;
- terminal illness or a prognosis of survival under three months.
About this study
Official title: Triple-Blind Clinical Trial With Placebo Control to Evaluate the Efficacy of a Heparin of Low Molecular Weight (Bemiparin) for Treating Slow-Responding Ulcers in Diabetic Foot in Primary Care
To assess the efficacy of bemiparin (low molecular weight heparin) for 3 months in the treatment of chronic foot ulcers in diabetic patients.
Read the detailed description
The involvement of microcirculation in diabetes microangiopathy may be the cause of ulceration and severe incapacitation. Torpid ulcers of the lower limbs affect up to 15% of diabetic patients at some moment of their lifetime; about one-third of patients developing ulcers will never achieve their definitive cure, and half of them will die within three years .
Heparins, besides their well known antithrombotic effects, have been shown to stimulate both the synthesis of heparan sulphate -a potent endogenous anticoagulant- in endothelial cell cultures and the proliferation of fibroblasts taken from diabetic ulcers .
After noticing the highly positive evolution of chronic ulcers in six diabetic patients who had received LMWHs in their homes for the prophylaxis of deep vein thrombosis , and considering the excellent safety record of these drugs, we decided to explore the effects of LMWHs on the evolution of diabetic foot ulcers and the quality of life of diabetic patients seen in our primary care practices.
Comparison: bemiparin vs placebo
- Conditions
- Foot Ulcer, Diabetic, Diabetic Angiopathies
- Being tested
- bemiparin (low molecular weight heparin)
- Keywords
- Heparin, Low-Molecular-Weight, Bemiparin, Foot Ulcer, Diabetic, Diabetic Angiopathies, Primary Health Care
- Medical subject headings
- Diabetic Foot, Diabetic Angiopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bemiparin (low molecular weight heparin)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer area
Stage in Wagner's classification
Secondary outcomes (2)
Adverse effects
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
- Study startJun 2001
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 84 participants
Sponsor and investigators
- Lead sponsor
- Spanish National Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute, Rovi Pharmaceuticals Laboratories
- Investigators
- Manuel Rullan, MD, Principal investigator, Primary health care of Mallorca. Ibsalut.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399425
- Sponsor's protocol ID
- APM/00/PD1
- Other IDs
- AEM 01-0167
- Status last verified
- Nov 2006
- First submitted
- 13 Nov 2006
- Last updated
- 14 Nov 2006
- Results posted
- No
Publications
Rullan M, Cerda L, Frontera G, Llobera J, Masmiquel L, Olea JL. [Triple-blind clinical trial with placebo control to evaluate the efficacy of a heparin of low molecular weight (bemiparin) for treating slow-responding ulcers in diabetic foot in primary care]. Aten Primaria. 2003 May 15;31(8):539-44. doi: 10.1016/s0212-6567(03)70729-x. Spanish.
PubMed 12765594
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple-Blind Clinical Trial With Placebo Control to Evaluate the Efficacy of a Heparin of Low Molecular Weight (Bemiparin) for Treating Slow-Responding Ulcers in Diabetic Foot in Primary Care
- ClinicalTrials.gov ID
- NCT00399425
- Acronym / sponsor ID
- APM/00/PD1
- Conditions
- Foot Ulcer, Diabetic, Diabetic Angiopathies
- Keywords
- Heparin, Low-Molecular-Weight, Bemiparin, Foot Ulcer, Diabetic, Diabetic Angiopathies, Primary Health Care
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 84 participants
- Lead sponsor
- Spanish National Health SystemUniversity, hospital or other
- Collaborators
- Carlos III Health Institute, Rovi Pharmaceuticals Laboratories
- Study start
- Jun 2001
- Study completion
- Apr 2004
- First posted
- 14 Nov 2006 (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.
To assess the efficacy of bemiparin (low molecular weight heparin) for 3 months in the treatment of chronic foot ulcers in diabetic patients.
Detailed description
The involvement of microcirculation in diabetes microangiopathy may be the cause of ulceration and severe incapacitation. Torpid ulcers of the lower limbs affect up to 15% of diabetic patients at some moment of their lifetime; about one-third of patients developing ulcers will never achieve their definitive cure, and half of them will die within three years .
Heparins, besides their well known antithrombotic effects, have been shown to stimulate both the synthesis of heparan sulphate -a potent endogenous anticoagulant- in endothelial cell cultures and the proliferation of fibroblasts taken from diabetic ulcers .
After noticing the highly positive evolution of chronic ulcers in six diabetic patients who had received LMWHs in their homes for the prophylaxis of deep vein thrombosis , and considering the excellent safety record of these drugs, we decided to explore the effects of LMWHs on the evolution of diabetic foot ulcers and the quality of life of diabetic patients seen in our primary care practices.
Comparison: bemiparin vs placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age over 18 years;
- type I or II diabetes mellitus diagnosed (ADA 1998) for more than 3 years;
- presence of at least one cutaneous ulcer distal to the knee, not involving deep tissues (stages I and II of Wagner's classification ) and existing for at least three months;
- giving their written informed consent.
Key exclusion criteria (10 listed)
- hypersensibility to heparin or pig derivatives
- body weight lower than 35 kg
- presence of clinical signs of infection that did not resolve in spite of oral antibiotics;
- anticoagulant therapy;
- severe impairment of renal or hepatic function;
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 |
|---|---|---|
| bemiparin (low molecular weight heparin) | Drug | – |
Primary outcome
Ulcer area
Stage in Wagner's classification
2 secondary outcomes
Adverse effects
Quality of life
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2006.
- Background: PubMed 12765594Rullan M, Cerda L, Frontera G, Llobera J, Masmiquel L, Olea JL. [Triple-blind clinical trial with placebo control to evaluate the efficacy of a heparin of low molecular weight (bemiparin) for treating slow-responding ulcers in diabetic foot in primary care]. Aten Primaria. 2003 May 15;31(8):539-44. doi: 10.1016/s0212-6567(03)70729-x. Spanish.
Related trials for Foot Ulcer, Diabetic
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
Manuel Rullan, MD principal investigator
Primary health care of Mallorca. Ibsalut.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing bemiparin (low molecular weight heparin) in people with Foot Ulcer, Diabetic and Diabetic Angiopathies, run by Spanish National Health System.
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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 14 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. Results are not available in the source record.
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?
Ulcer area. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00399425, which also lists 1 linked publication.
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 14 Nov 2006.