PriMatrix for the Management of Diabetic Foot Ulcers

Not Applicable

Completed

• Conditions: Diabetic Foot Ulcer

• Registration Number: NCT03010319
• Lead Sponsor: Integra LifeSciences Corporation

Brief Summary

The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the management of diabetic foot ulcers in subjects with diabetes mellitus versus the Standard of Care treatment. Half of patients will be treated using PriMatrix while the other half will receive Standard of Care treatment.

Detailed Description

A diabetic foot ulcer (DFU) is a major health complication that affects up to 15% of individuals with diabetes mellitus over their lifetime. The treatment of DFUs is extremely challenging as these ulcers may not respond to standard of care (SC) treatment and frequently become infected.

Advanced wound therapies like PriMatrix have become an important strategy in the treatment of hard-to-heal chronic DFUs by trapping and binding the patients' own cells to rebuild the dermis layer of the skin to aid in healing.

The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the closure of DFUs in subjects with diabetes mellitus in comparison to Standard of Care treatment.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-05
• Primary Completion: 2020-08
• Study Completion: 2020-08
• Results First Submitted: 2022-01-24
• Results First Submitted QC: 2022-03-11
• Results First Posted: 2022-03-15
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Complete Wound Closure, as Assessed by the Investigator, at or Before Week 12 of the Treatment Phase	12-week Treatment Phase	Complete wound closure was defined as 100% re-epithelialization of the ulcer surface without detectable exudate, confirmed on 2 consecutive study visits 1 week apart.

Secondary Outcome Measures

Name	Time	Method
Time to Complete Wound Closure, as Assessed by Computerized Planimetry.	12-week Treatment Phase
Rate of Wound Closure, as Assessed by Computerized Planimetry.	Weeks 1-12 during Treatment Phase	Rate of Wound closure was recorded as the percentage of the wound that was closed, per week.; NOTE1: Rate (% closed/week) = 7 \* \[(Baseline wound size) - (Post-baseline wound size)\]/\[(Baseline wound size) \* (days in trial)\] NOTE2: Missing data is imputed using LOCF method for this analysis
Time to Complete Wound Closure, as Assessed by the Investigator	12-week Treatment Phase
Percentage of Subjects With Complete Wound Closure, as Assessed by Computerized Planimetry, at or Before Week 12 of the Treatment Phase	12-week treatment phase

Trial Locations

Locations (17)

ILD Research Center; 🇺🇸 Carlsbad, California, United States

LA Foot & Ankle Clinic; 🇺🇸 Los Angeles, California, United States

Center for Clinical Research, Inc.; 🇺🇸 San Francisco, California, United States

Central Valley Vein and Wound; 🇺🇸 Selma, California, United States

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

Barry University Clinical Research; 🇺🇸 North Miami, Florida, United States

LA Podiatry Group; 🇺🇸 West Palm Beach, Florida, United States

Podiatry 1st; 🇺🇸 Belleville, Illinois, United States

The Mount Sinai Medical Center; 🇺🇸 New York, New York, United States

Wound Care of Tulsa; 🇺🇸 Tulsa, Oklahoma, United States

Scroll for more (7 remaining)