NCT02750280

A Longitudinal Study to Evaluate an Extracellular Matrix (MatriStem®) for the Treatment of Diabetic Foot Ulcers

A Prospective, Randomized, Controlled, Longitudinal Study Using Repeated Measures Design to Evaluate a Porcine Urinary Bladder-Derived Extracellular Matrix (MatriStem®) in the Management of Diabetic Foot Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Calvary Hospital, Bronx, NY · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This ia a prospective controlled longitudinal study to evaluate the effects of MatriStem® plus standard local wound care versus standard local wound care alone in the treatment of diabetic foot ulcers (DFUs), as assessed by incidence of complete wound healing by 16 weeks and ulcer recurrence with a 2 year follow-up.

Conditions

• Neuropathic Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	MatriStem® [Urinary Bladder Matrix (UBM)]	Porcine derived urinary bladder extracellular matrix
DEVICE	Mepilex® [Silicone foam dressing]	primary wound dressing

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2016-04-25
• Last updated: 2016-04-25

Locations

1 site across 1 country: United States