Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434538
Status:
TERMINATED
Last Update Posted:
2009-02-05
First Post:
2007-02-09
Brief Title:
BST-DERMON Versus Standard of Care in the Treatment of Diabetic Foot Ulcers
Sponsor:
BioSyntech Canada Inc
Organization:
BioSyntech Canada Inc
Study Overview
Official Title:
A Multicenter Prospective Randomized Comparison Study of BST-DERMON Versus Standard of Care in the Treatment of Diabetic Foot Ulcers
Status:
TERMINATED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to Sponsors financial reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial is designed to investigate the therapeutic benefits of using BST-DermOn for the wound repair of diabetic neuropathic foot ulcers
The objective of this study is to evaluate the safety and efficacy of BST-DermOn in providing a clinically significant advantage over the standard of care in the repair of diabetic foot ulcers
The objective of this study is to evaluate the safety and efficacy of BST-DermOn in providing a clinically significant advantage over the standard of care in the repair of diabetic foot ulcers
Detailed Description:
This trial is designed to investigate the therapeutic benefits of using BST-DermOn for the wound repair of diabetic neuropathic foot ulcers BST-DermOn is a sterile non-toxic nonpyrogenic wound dressing composed of an aqueous mixture of Chitosan hydrochloric acid HCl and disodium beta-glycerol phosphate β-GP designed to address current wound healing needs Chitosan has well documented wound healing properties as well as inherent haemostatic and bacteriostatic capabilities BST-DermOn is used in conjunction with a defined standard of care and is applied over a prepared and debrided ulcer and covered with a semi-occlusive secondary dressing
This prospective multi-center randomized controlled study will enrol 130 type 1 or type 2 diabetic subjects presenting with a Grade 1 or Grade 2 Wagner classification diabetic foot ulcer of 1-10cm² on the mid or forefoot Subjects who meet the eligibility criteria will be assigned to one of two groups
1 a control group that will receive the standard of care or
2 a treatment group that will receive BST-DermOn
Treatments in both groups will be applied three 3 times a week for up to twenty consecutive weeks or until the study ulcer is closed All subjects will be followed for safety and efficacy during treatment visits through a final evaluation visit There will be a post treatment follow-up visit at 4 weeks post-closure for subjects with complete re-epithelialization
The objective of this study is to evaluate the safety and efficacy of BST-DermOn in providing a clinically significant advantage over the standard of care in the repair of diabetic foot ulcers
This prospective multi-center randomized controlled study will enrol 130 type 1 or type 2 diabetic subjects presenting with a Grade 1 or Grade 2 Wagner classification diabetic foot ulcer of 1-10cm² on the mid or forefoot Subjects who meet the eligibility criteria will be assigned to one of two groups
1 a control group that will receive the standard of care or
2 a treatment group that will receive BST-DermOn
Treatments in both groups will be applied three 3 times a week for up to twenty consecutive weeks or until the study ulcer is closed All subjects will be followed for safety and efficacy during treatment visits through a final evaluation visit There will be a post treatment follow-up visit at 4 weeks post-closure for subjects with complete re-epithelialization
The objective of this study is to evaluate the safety and efficacy of BST-DermOn in providing a clinically significant advantage over the standard of care in the repair of diabetic foot ulcers
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