NCT02571738

Study to Evaluate the Safety and Efficacy of CHAM* for the Treatment of Diabetic Foot Ulcers

A Multicenter, Randomized, Single-Blind Study With an Open-Label Extension Option to Further Evaluate the Safety and Efficacy of Cryopreserved Human Amniotic Membrane for the Treatment of Chronic Diabetic Foot Ulcers

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Osiris Therapeutics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A Multicenter, Randomized, Single-Blind Study with an Open-Label Extension Option to Further Evaluate the Safety and Efficacy of Cryopreserved Human Amniotic Membrane for the Treatment of Chronic Diabetic Foot Ulcers

Conditions

• Chronic Diabetic Foot Ulcers

Interventions

Type	Name	Description
BIOLOGICAL	CHAM	The treatment indication is for chronic diabetic foot ulcers that can accommodate up to one 5cm x 5cm piece of CHAM
OTHER	Control	Standard of Care

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-04-01
• Completion: 2017-06-01
• First posted: 2015-10-08
• Last updated: 2017-10-06

Locations

18 sites across 1 country: United States