Clinical Trial: Clinical Trial of ECLIPSE PRP™ Wound Biomatrix in Chronic Non-Healing Pressure Ulcers
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: A Prospective, Randomized Clinical Trial of ECLIPSE PRP™ Wound Biomatrix in Chronic Non-Healing Pressure Ulcers
Brief Summary: To assess the efficacy of the Eclipse PRP™ Wound Biomatrix and compare its performance with usual and customary practice for the treatment of chronic non-healing pressure ulcers (PU).
Detailed Summary: This is a prospective, randomized, single-blind, controlled, multi-center study for subjects undergoing PU treatment. Qualified subjects will be randomized (1:1); test group (Eclipse PRP™ Wound Biomatrix) and control group (usual and customary practice). The study will consist of 3 periods: a screening period, an active treatment period, and a follow-up period (if healed). Approximately 250 subjects will be enrolled. Subjects will be ≥18 years of age with a PU (greater than 4 weeks duration). Each subject will be enrolled in the active treatment period for up to 12 weeks, or to closure of wound with a confirmatory visit 2 weeks after wound closure, whether such closure occurs at 12 weeks or earlier.
Sponsor: PRP Concepts, LLC
Current Primary Outcome:
- Time to complete wound closure [ Time Frame: 12 weeks ]Complete wound closure is defined as full epithelialization of the wound with the absence of drainage, durability confirmed at 2 weeks
- Percent of wounds healed [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Wound trajectory (Mean Change) [ Time Frame: 12 weeks ]Mean of percent (%) wound size changes at 4 weeks, 8 weeks and 12 weeks
- Wound trajectory (Median Change) [ Time Frame: 12 weeks ]Median of percent (%) wound size changes at 4 weeks, 8 weeks and 12 weeks
- Ulcer recurrence [ Time Frame: 3 months ]Ulcer recurrence out to 3 months for subjects whose wounds heal by conclusion of 12 week visit.
- Quality of Life [ Time Frame: 3 months ]Changes in Quality of Life scores and ability to return to previous function/resumption of normal activities
Original Secondary Outcome:
- Wound trajectory [ Time Frame: 12 weeks ]Mean and median of percent (%) wound size changes at 4 weeks, 8 weeks and 12 weeks
- Ulcer recurrence [ Time Frame: 3 months ]Ulcer recurrence out to 3 months for subjects whose wounds heal by conclusion of 12 week visit.
- Quality of Life [ Time Frame: 3 months ]Changes in Quality of Life scores and ability to return to previous function/resumption of normal activities
Information By: PRP Concepts, LLC
Dates:
Date Received: December 5, 2014
Date Started: July 2016
Date Completion: July 2018
Last Updated: March 28, 2016
Last Verified: March 2016