Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-27 @ 1:49 AM
Study NCT ID:
NCT02236793
Status:
COMPLETED
Last Update Posted:
2017-06-29
First Post:
2014-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 3 Clinical Trial to Assess the Effectiveness of BioChaperone PDGF-BB In the Treatment of Chronic Diabetic Foot Ulcer
Sponsor:
Adocia
Organization:
Study Overview
Official Title:
Phase III, Multicentre, Randomized, Parallel Group, Double Blinded and Control Group Clinical Trial to Assess the Effectiveness of BioChaperone PDGF-BB In the Treatment of Chronic Diabetic Foot Ulcer
Status:
COMPLETED
Status Verified Date:
2017-06
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:
The present clinical trial is designed to assess the effectiveness of BioChaperone PDGF-BB applied at 4 µg/cm² every other day for up to 20 weeks and associated to Standard of Care as compared to Standard of Care alone for the treatment of neuropathic and neurovascular diabetic foot ulcers.(In order to ensure the double-blinding of the treatments, a sterile normal saline solution presented in the same multi-dose spray vials than BioChaperone PDGF-BB will be applied on patients of the control group).
Detailed Description:
None
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?: