Clinical Trial: A Cohort Trial Comparing AutoloGel Therapy to Usual and Customary Care in Venous Leg 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 Venous Leg Ulcers

Brief Summary: The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, cohort-controlled trial in which venous leg ulcers (VLU)n will be treated using AutoloGel and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care (UCC)

Detailed Summary: Recurrence of ulcers in the leg is common; two-thirds of patients are likely to experience recurring ulcers after the first ulcer. While treatment of the underlying venous disease, depending on the mode of treatment, can lower the recurrence rate in many patients, it does not affect recurrence. AutoloGel is a platelet-rich plasma (PRP) gel used in the treatment of non-healing chronic wounds. The aim of this trial is to demonstrate the effectiveness, measured as complete wound healing, in a prospective, open-label trial in which venous leg ulcers will be treated using AutoloGel and standard of care and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care
Sponsor: Cytomedix

Current Primary Outcome: Time to wound closure [ Time Frame: 12 weeks ]

Primary endpoint is time to wound healing after 12 weeks com pared with case matched controls receiving standard of care. 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:

  • Proportion of wounds healed [ Time Frame: 12 weeks ]
    Comparison of proportion of wounds healed over 12 weeks
  • Frequency of ulcer recurrence [ Time Frame: 1 year ]
    Frequency of ulcer recurrence over a 1 year period post treatment; recurrence is defined as any new ulcer appearing on the leg after the index ulcer has healed.
  • Change in Quality of Life with Chronic Wounds (W-QOL) Score [ Time Frame: 12 weeks ]
    Change in mean Quality of Life with Chronic Wounds (W-QOL) score between baseline and at 12 weeks
  • Number of patients with adverse events as a measure of tolerability [ Time Frame: 12 weeks ]
    Frequency and severity of treatment emergent adverse events


Original Secondary Outcome:

  • Proportion of wounds healed [ Time Frame: 12 weeks ]
    Comparison of proportion of wounds healed over 12 weeks
  • Frequency of ulcer recurrence [ Time Frame: 1 year ]
    Frequency of ulcer recurrence over a 1 year period post treatment; recurrence is defined as any new ulcer appearing on the leg after the index ulcer has healed.
  • Change in W-QOP Score [ Time Frame: 12 weeks ]
    Change in mean Quality of Life with Chronic Wounds (W-QOL) score between baseline and at 12 weeks
  • Number of patients with adverse events as a measure of tolerability [ Time Frame: 12 weeks ]
    Frequency and severity of adverse events, change in vital signs and physical examination from baseline


Information By: Cytomedix

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