NCT01858545

A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers

An Evaluation of Tissue Engineering Approaches for Treatment of Neuropathic Diabetic Foot Ulcers Resistant to Standard of Care: A Prospective, Randomized Controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the effectiveness of MatriStem devices compared to cellular dermal replacement tissue, for the treatment of non-healing diabetic foot ulcers.

Detailed description

Due to their characteristically poor healing capacity, diabetic foot ulcers (DFUs) are challenging for clinicians to treat. This prospective, multi-center clinical study will examine outcomes following treatment of DFUs, with one of two FDA cleared tissue-engineered devices, MatriStem® or cellular dermal replacement tissue, on DFUs that have demonstrated an inadequate response to initial standard of care therapy. The incidence of ulcer closure, rate of wound closure, and quality of life will be evaluated over a eight week period.

Conditions

• Foot Ulcer, Diabetic

Interventions

Type	Name	Description
DEVICE	MatriStem	MatriStem MicroMatrix and MatriStem Wound Matrix
DEVICE	Cellular Dermal Replacement Tissue	Cellular Dermal Replacement Tissue

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-05-21
• Last updated: 2021-04-15
• Results posted: 2018-03-29

Locations

9 sites across 1 country: United States