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Comparing the Efficacy and Safety of Two Dose Regimens of BioChaperone PDGF-BB to Becaplermin Gel for the Treatment of Diabetic Foot Ulcer

2014-07-23 21:09:38 | BioPortfolio

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.

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

- Beclapermin gel 6.25 µg/cm²/application for 20 weeks.

The assessment schedule for all the three 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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Diabetic Foot Ulcers

Intervention

Biochaperone PDGF-BB Low dose, Biochaperone PDGF-BB High dose, Regranex

Location

Vijay Vachharajani Memorial
Rajkot
Gujarat
India
560069

Status

Not yet recruiting

Source

Virchow Group

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:38-0400

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Medical and Biotech [MESH] Definitions

A PDGF receptor that binds specifically to both PDGF-A chains and PDGF-B chains. It contains a protein-tyrosine kinase activity that is involved in SIGNAL TRANSDUCTION.

A PDGF receptor that binds specifically to the PDGF-B chain. It contains a protein-tyrosine kinase activity that is involved in SIGNAL TRANSDUCTION.

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A treatment schedule in which the total dose of radiation is divided into large doses.

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