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