NCT00493051

Phase 2b Study of GAM501 in the Treatment of Diabetic Ulcers of the Lower Extremities

A Randomized, Double-Blind, Placebo-Controlled, Single- and Double-Dose, Comparator Arm (Standard of Care), Multicenter Phase 2b Study of Topical GAM501 (Ad5PDGF-B/Bovine Type I Collagen Gel) in the Treatment of Non-Healing Diabetic Ulcers of the Lower Extremities

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Tissue Repair Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2b, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of one or two applications of topically applied GAM501 (Ad5PDGF-B/Bovine Type I Collagen Gel) in subjects ≥ 18 years old with non-healing diabetic foot ulcers. Approximately 210 adult subjects with Type I or Type II diabetes mellitus will be enrolled at approximately 30 investigational sites in the United States.

Conditions

• Diabetic Foot

Interventions

Type	Name	Description
BIOLOGICAL	GAM501	Ad5PDGF-B formulated in a collagen gel
BIOLOGICAL	Placebo	Collagen gel
OTHER	Standard of care	moist dressing changes daily

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2007-06-27
• Last updated: 2010-02-10

Locations

29 sites across 1 country: United States