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

Foot Ulcer, Diabetic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01858545
• Other study ID #: ACL2011-002-I
• Status: Terminated
• Phase: N/A
• Start date: May 2013
• Est. completion date: December 2015

Study information

• Verified date: March 2021
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Major 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

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic
• Ulcer

Intervention

Device:
• MatriStem
MatriStem MicroMatrix and MatriStem Wound Matrix
• Cellular Dermal Replacement Tissue
Cellular Dermal Replacement Tissue

Locations

Country	Name	City	State
United States	Center for Clinical Research Inc.	Castro Valley	California
United States	Denver VA Medical Center	Denver	Colorado
United States	Valley Vascular Surgery Associates	Fresno	California
United States	Advanced Research Institute of Miami	Homestead	Florida
United States	NewPhase Clinical Trials, Corp.	Miami Beach	Florida
United States	Associated Foot & Ankle Specialists, PC	Phoenix	Arizona
United States	Carl t. Hayden Phoenix VA Medical Center	Phoenix	Arizona
United States	Professional Health Care of Pinellas	Saint Petersburg	Florida
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Complete Wound Closure	Number of participants with incidence of complete wound closure	8 Weeks