Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399425
Status:
TERMINATED
Last Update Posted:
2006-11-14
First Post:
2006-11-13
Brief Title:
Efficacy of a Low-Molecular-Weight Heparin Bemiparin in the Treatment of Chronic Foot Ulcers in Diabetic Patients
Sponsor:
Spanish National Health System
Organization:
Spanish National Health System
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AEM 01-0167 | None | None | None |