Trials / Completed
CompletedNCT02236793
A Phase 3 Clinical Trial to Assess the Effectiveness of BioChaperone PDGF-BB In the Treatment of Chronic Diabetic Foot Ulcer
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 252 (actual)
- Sponsor
- Adocia · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BioChaperone PDGF-BB | |
| OTHER | Standard of Care |
Timeline
- Start date
- 2014-12-01
- Primary completion
- 2016-08-01
- Completion
- 2016-08-01
- First posted
- 2014-09-11
- Last updated
- 2017-06-29
Locations
32 sites across 1 country: India
Source: ClinicalTrials.gov record NCT02236793. Inclusion in this directory is not an endorsement.