NCT01098357

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

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Virchow Group · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Diabetic Foot Ulcers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-02-01
• Completion: 2011-09-01
• First posted: 2010-04-02
• Last updated: 2014-12-15

Locations

7 sites across 1 country: India