Comparative Study of 3 Dose Regimens of BioChaperone to Becaplermin Gel for the Treatment of Diabetic Foot Ulcer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

192

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

February 28, 2011

Study Completion Date

September 30, 2011

Conditions
Diabetic Foot Ulcers
Interventions
DRUG

Biochaperone PDGF-BB Low dose

BioChaperone PDGF-BB low dose is applied as a spray every two days at the dose of 12.5 µg/cm2 for up to 20 weeks

DRUG

Biochaperone PDGF-BB High dose

BioChaperone PDGF-BB high dose is applied as a spray every two days at the dose of 25 µg/cm2 for up to 20 weeks

DRUG

Regranex

Regranex gel is applied once daily at the dose of 6.25 µg/cm2 for up to 20 weeks

DRUG

Biochaperone PDGF-BB Very Low Dose

BioChaperone PDGF-BB Very Low Dose sprayed on the wound every two days (e.g., Mondays, Wednesdays and Fridays) for 20 weeks or until complete wound healing, at the dose of 4 µg/cm²/application

Trial Locations (7)

560052

Jain Institute of Vascular sciences, Bangalore

560069

Karnataka Institute of Diabetology, Bangalore

600013

M.V. Hospital for Diabetes, Chennai

Unknown

Vijay Vachharajani Memorial, Rajkot

Joshi Hospital , Maharashra Medical Foundation, Pune

682 040

Lakeshore Hospital & Research Centre Ltd, Kochi

700 009

S.K. Diabetes Research & Education Centre, Kolkata

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Adocia

INDUSTRY

lead

Virchow Group

INDUSTRY

NCT01098357 - Comparative Study of 3 Dose Regimens of BioChaperone to Becaplermin Gel for the Treatment of Diabetic Foot Ulcer | Biotech Hunter | Biotech Hunter