A Phase 3 Clinical Trial to Assess the Effectiveness of BioChaperone PDGF-BB In the Treatment of Chronic Diabetic Foot Ulcer

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).

Timeline

Start

2014-12

Primary completion

2016-08

Completion

2016-08

Outcome

Missed primary endpoint

release “BioC haperone PDGF-BB did not meet the primary endpoint of the Phase 3 clinical study that had been performed in India” adocia.com ↗

Drugs

Indications