A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Chronic Non-Healing Pressure Ulcers
NCT02312570 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2021-04-13
Summary
To assess the efficacy of the PRP Concepts Fibrin Bio-Matrix and compare its performance with usual and customary practice for the treatment of chronic non-healing pressure ulcers (PU).
Conditions
- Pressure Ulcer
Interventions
- DEVICE
-
PRP Concepts Fibrin Bio-Matrix
Administration of PRP Concepts Fibrin Bio-Matrix to wound in addition to usual and customary care
- OTHER
-
Usual and Customary Practice
Ussual and customary care of non-healing pressure wounds
Sponsors & Collaborators
-
PRP Concepts, LLC
lead INDUSTRY
Principal Investigators
-
Damon Keeley · PRP Concepts, LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-01-01
- Primary Completion
- 2021-12-31
- Completion
- 2021-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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