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
1 other identifier
interventional
56
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2013
Typical duration for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 17, 2013
CompletedFirst Posted
Study publicly available on registry
May 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
March 29, 2018
CompletedApril 15, 2021
March 1, 2021
2.6 years
May 17, 2013
February 27, 2018
March 19, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Complete Wound Closure
Number of participants with incidence of complete wound closure
8 Weeks
Study Arms (2)
Experimental
EXPERIMENTALMatriStem MicroMatrix and MatriStem Wound Matrix
Comparator
ACTIVE COMPARATORCellular Dermal Replacement Tissue
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Carl t. Hayden Phoenix VA Medical Center
Phoenix, Arizona, 85012, United States
Associated Foot & Ankle Specialists, PC
Phoenix, Arizona, 85015, United States
Center for Clinical Research Inc.
Castro Valley, California, 94546, United States
Valley Vascular Surgery Associates
Fresno, California, 93720, United States
Denver VA Medical Center
Denver, Colorado, 80220, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Advanced Research Institute of Miami
Homestead, Florida, 33030, United States
NewPhase Clinical Trials, Corp.
Miami Beach, Florida, 33140, United States
Professional Health Care of Pinellas
St. Petersburg, Florida, 33713, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Manager, Clinical Research
- Organization
- Integra LifeSciences
Study Officials
- STUDY DIRECTOR
Thomas Gilbert, PhD
Integra LifeSciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2013
First Posted
May 21, 2013
Study Start
May 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
April 15, 2021
Results First Posted
March 29, 2018
Record last verified: 2021-03