Clinical Trial: AutoloGel Therapy to Usual and Customary Care in Pressure Ulcers

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Multi-Center, Prospective, Cohort Trial Comparing the Effectiveness of AutoloGel Therapy to Usual and Customary Care in Stage II-IV Pressure Ulcers

Brief Summary: The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, case-matched cohort-controlled trial in which pressure ulcers will be treated using AutoloGel and standard care and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care.

Detailed Summary: Pressure ulcers (PUs) are a common problem in all patient care settings, especially long-term acute care facilities and nursing homes. AutoloGel is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds. The results of AutoloGel to date when used to treat PUs have been promising. The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, case-matched cohort trial in which pressure ulcers will be treated using AutoloGel and standard of care to determine time to heal at 16 weeks. Comparison will be made with a case matched concurrent cohort of patients receiving undefined Usual and Customary Care.
Sponsor: Cytomedix

Current Primary Outcome: Time to complete wound healing [ Time Frame: 16 weeks ]

Compare complete wound healing at 16 weeks for all pressure ulcers treated with AutoloGel plus standard of care with case-matched concurrent controls. Complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart (FDA Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds ─ Developing Products for Treatment, 2006).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Ulcer recurrence [ Time Frame: 1 year ]
    Frequency of ulcer recurrence (recurrence defined as any new ulcer that has appeared since the Index Ulcer healed)
  • Proportion of healed ulcers [ Time Frame: 16 weeks ]
    Proportion of patients with completely healed pressure ulcers
  • W-QOL (Quality of Life with Chronic Wounds) score [ Time Frame: 16 weeks ]
    Change in mean W-QOL (Quality of Life with Chronic Wounds) score between baseline and 16 weeks
  • Number of patients with adverse events as a measure of tolerability [ Time Frame: 16 weeks ]
    Frequency and severity of adverse events during the study


Original Secondary Outcome: Same as current

Information By: Cytomedix

Dates:
Date Received: March 21, 2013
Date Started: April 2013
Date Completion:
Last Updated: October 19, 2016
Last Verified: October 2016