Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-25 @ 4:28 PM
Study NCT ID:
NCT01098357
Status:
COMPLETED
Last Update Posted:
2014-12-15
First Post:
2010-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Study of 3 Dose Regimens of BioChaperone to Becaplermin Gel for the Treatment of Diabetic Foot Ulcer
Sponsor:
Virchow Group
Organization:
Study Overview
Official Title:
A Phase I/II, Multicentre, Randomised, Controlled, and Open-label Trial Comparing the Efficacy and Safety of Three Dose Regimens of BioChaperone PDGF-BB to Becaplermin Gel for the Treatment of Diabetic Foot Ulcer
Status:
COMPLETED
Status Verified Date:
2012-08
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:
This is an open-label, active-control, multicentre, parallel group, randomised and dose-finding efficacy and safety study.
Compare the efficacy and safety of BioChaperone PDGF-BB applied at 12.5 µg/cm² every two days for up to 20 weeks to becaplermin gel (Regranex® Gel 0.01%) applied daily for up to 20 weeks for the treatment of neuropathic diabetic foot ulcer.
Assess the effect of a double dose of BioChaperone PDGF-BB (25 µg/cm²) applied every two days for up to 20 weeks.
Compare the efficacy and safety of BioChaperone PDGF-BB applied at 12.5 µg/cm² every two days for up to 20 weeks to becaplermin gel (Regranex® Gel 0.01%) applied daily for up to 20 weeks for the treatment of neuropathic diabetic foot ulcer.
Assess the effect of a double dose of BioChaperone PDGF-BB (25 µg/cm²) applied every two days for up to 20 weeks.
Detailed Description:
After the screening visit, the eligible patient population randomly receive one of the three following topical drugs:
* BioChaperone™ PDGF-BB 12.5 µg/cm²/application for 20 weeks,
* BioChaperone™ PDGF-BB 25 µg/cm²/application for 20 weeks, or
* BioChaperone™ PDGF-BB 4 µg/cm²/application for 20 weeks, or
* Beclapermin gel 6.25 µg/cm²/application for 20 weeks.
The assessment schedule for all the four groups is weekly once (7 day duration) till the 8th week (visit 10) and once in two weeks (14 day duration) thereafter till the end of study. The maximum number of visits expected is 16. The study data is presented at the end of 20 weeks.
* BioChaperone™ PDGF-BB 12.5 µg/cm²/application for 20 weeks,
* BioChaperone™ PDGF-BB 25 µg/cm²/application for 20 weeks, or
* BioChaperone™ PDGF-BB 4 µg/cm²/application for 20 weeks, or
* Beclapermin gel 6.25 µg/cm²/application for 20 weeks.
The assessment schedule for all the four groups is weekly once (7 day duration) till the 8th week (visit 10) and once in two weeks (14 day duration) thereafter till the end of study. The maximum number of visits expected is 16. The study data is presented at the end of 20 weeks.
Study Oversight
Has Oversight DMC:
False
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?: