Registry Trial of the Effectiveness of Platelet Rich Plasma for Chronic Non-Healing Wounds

  • STATUS
    Not Recruiting
  • participants needed
    1500
  • sponsor
    Arteriocyte, Inc.
Updated on 22 January 2021
wound care
diabetic foot
venous stasis
foot ulcer
pressure ulcer

Summary

This study will examine differences in the process of wound-healing in patients treated with platelet rich plasma (a concentration of proteins derived from a patients own blood) applied to the wound as a gel; injected into the wound or surrounding tissue; or both; compared to patients treated with usual medical treatment . This study seeks to enroll patients who are 18 or older with a non-healing skin wound that is at least 30 days old. Only patients with Diabetic Foot Ulcers, Venous Ulcers, or Pressure Ulcers will be included in the study.

Description

The proposed investigation is designed to solicit a large number of patients (N=1,500) with non-healing wounds (Diabetic Foot Ulcers, Venous Ulcers, or Pressure Ulcers) that have not responded to standard wound care in the previous 30 days or more. A prospective, interventional, single-blinded, controlled, registry trial will be used. Data will be analyzed to compare patients who received PRP therapy (PRP gel application, PRP injection, or both) and standard wound care (usual customary care) with patients who received standard wound care (usual customary care), only. Wound size, rate of healing, quality of life, and recurrence of wound will be measured during the 16-week period at usual office visits. Hypotheses to be tested: 1. Treatment of a chronic wound with standard of care and autologous platelet rich plasma (PRP) will increase the velocity of healing (rate of wound closure) over a twenty week period as compared to patients receiving standard wound care only (Control Group), which results in the patient's ability to return to previous function and resumption of normal activities. 2. Treatment of a chronic wound with standard of care and autologous platelet rich plasma (PRP) will result in complete wound healing within twenty weeks, whereas complete wound healing will not be observed within twenty weeks in patients receiving standard wound care only (Control Group).

Details
Condition Varicose Ulcer, Decubitus Ulcer, Diabetic Foot
Treatment Autologous PRP Gel, Autologous PRP Injections, Autologous PRP Gel plus PRP Injections, Standard Wound Care
Clinical Study IdentifierNCT02071979
SponsorArteriocyte, Inc.
Last Modified on22 January 2021

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