Integra DFU
Researchers want to find out more about a device called PriMatrix® Dermal Repair Scaffold. PriMatrix is an
approved device for treatment of diabetic foot ulcers as well as other medical problems.
The main purpose of this study is to see if PriMatrix® Dermal Repair Scaffold is effective in the management of
diabetic foot ulcers in subjects with diabetes and without significantly decreased blood flow. In addition, safety
will be evaluated.
This study will compare the effects of PriMatrix® with the effects of the standard of care for diabetic foot ulcers.
Study phase: N/A
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
Inclusion:
The subject is 18 years of age.
The subject has at least one diabetic foot ulcer
Ulcer is located on the foot or ankle
Ulcer size (area) is> 1 cm2 and< 12 cm2
Exclusion
The subject has suspected or confirmed gangrene or ulcer infection
The subject has suspected or confirmed osteomyelitis
The subject has received any medication or treatment known to interfere with the rate and quality of healing such
as; systemic steroids, immunosuppressive therapy, autoimmune disease therapy, dialysis, radiation therapy to
the foot, vascular surgery, recent angioplasty,
Primary disease category: Diabetes & Endocrine System
Secondary disease categories: Diabetes & Endocrine System
Sponsor: Integra LifeSciences Corporation
Protocol number: T-PMXDFU-01
Projected enrollment dates: April 2020 to March 2022
Official study title: PROSPECTIVE, MULTI-CENTER, RANDOMIZED CONTROLLED TRIAL EVALUATING THE USE OF PRIMATRIX® DERMAL REPAIR SCAFFOLD FOR THE MANAGEMENT OF DIABETIC FOOT ULCERS
ClinicalTrials.gov page:
http://www.clinicaltrials.gov/show/NCT03010319