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

Not Applicable

Terminated

• Conditions: Foot Ulcer, Diabetic
• Interventions: Device: MatriStem; Device: Cellular Dermal Replacement Tissue

• Registration Number: NCT01858545
• Lead Sponsor: Integra LifeSciences Corporation

Brief 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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-17
• Study First Submitted QC: 2013-05-17
• Study First Posted: 2013-05-21
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Results First Submitted: 2018-02-27
• Results First Submitted QC: 2018-02-27
• Results First Posted: 2018-03-29
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-19
• Last Update Posted: 2021-04-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Subject has a current diagnosis of type I or type II diabetes
• Subject's ulcer is on the forefoot or heel
• Subject has chronic ulcer - has been present for minimum of 4 weeks
• Subject's ulcer extends through the dermis and into the subcutaneous tissue
• Subject's HgbA1c <12%
• Subject has adequate circulation to the study foot as evidenced by a Doppler measured ABI greater than or equal to 0.7after 10 minutes rest

Major

Exclusion Criteria

• Subject has a known sensitivity to bovine- or porcine-derived products.
• Subject's ulcer is due to a non-diabetic etiology
• Subject's ulcer is over a Charcot deformity of the mid-foot
• Subject's random blood sugar readings are >450 mg/dL
• Subject is on dialysis
• Subject has a non-study ulcer on the study limb located within 7.0 cm of the study ulcer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	MatriStem	MatriStem MicroMatrix and MatriStem Wound Matrix
Comparator	Cellular Dermal Replacement Tissue	Cellular Dermal Replacement Tissue

Primary Outcome Measures

Name	Time	Method
Number of Participants With Complete Wound Closure	8 Weeks	Number of participants with incidence of complete wound closure

Trial Locations

Locations (9)

Denver VA Medical Center; 🇺🇸 Denver, Colorado, United States

Professional Health Care of Pinellas; 🇺🇸 Saint Petersburg, Florida, United States

Center for Clinical Research Inc.; 🇺🇸 Castro Valley, California, United States

Advanced Research Institute of Miami; 🇺🇸 Homestead, Florida, United States

Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States

NewPhase Clinical Trials, Corp.; 🇺🇸 Miami Beach, Florida, United States

Carl t. Hayden Phoenix VA Medical Center; 🇺🇸 Phoenix, Arizona, United States

Associated Foot & Ankle Specialists, PC; 🇺🇸 Phoenix, Arizona, United States

Valley Vascular Surgery Associates; 🇺🇸 Fresno, California, United States