NCT01060670

A Safety and Efficacy Study of INTEGRA® Dermal Regeneration Template for the Treatment of Diabetic Foot Ulcers

A Multi-Center, Randomized, Controlled Clinical Trial to Evaluate The Safety and Effectiveness of Integra® Dermal Regeneration Template for the Treatment of Neuropathic Diabetic Foot Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 545 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety and efficacy of the INTEGRA® Dermal Regeneration Template for the treatment of diabetic foot ulcers located distal to the malleolus in subjects with diabetes mellitus, neuropathy, and without significantly compromised arterial circulation.

Conditions

• Neuropathic Diabetic Ulcer - Foot

Interventions

Type	Name	Description
DEVICE	Integra® Dermal Regeneration Template	Application of Integra® Dermal Regeneration Template in diabetic foot ulcer
OTHER	Conventional Wound Therapy	Conventional Wound Therapy

Timeline

• Start date: 2010-04-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2010-02-02
• Last updated: 2016-09-22
• Results posted: 2016-09-22

Locations

33 sites across 2 countries: United States, Netherlands Antilles