Effectiveness of Autologous Platelet Rich Plasma in the Treatment of Chronic Non-Healing Wounds
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Foot Ulcer Chronic
- Sponsor
- ACR Biologics, LLC
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Wound Closure
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
This investigation plans to initiate the healing of chronic wounds by providing a concentrated platelet and growth factor therapy directly to the wound site by topical delivery. This therapy will be derived from autologous platelet rich plasma (PRP), an emerging surgical and wound care treatment. This investigation aims to demonstrate that patients with chronic, non-healing wounds treated with autologous PRP and standard medical care have a reduction in wound volume and improved healing rate that results in patient-centered clinically significant health outcomes as compared to patients treated with standard medical care only.
Detailed Description
This is a multicenter randomized controlled trial, with a single-blind parallel design. 1,500 subjects are planned to enroll in the study. Each subject will be assigned to the treatments in random order. The stratified permuted block randomization method will be applied to the patient assignment. In addition to three study populations, i.e., DFU, VU and PU, and study centers, stratification will be based on one overall variable, (1) nutritional status (Low: Prealbumin \<12mg/d vs. moderate: Prealbumin \>= 12 mg/d) and one variable for each wound type. Diabetic food ulcer will be based on offloading (2a) (Specialty shoes vs. Total contact cast), pressure ulcer will be based on offloading (2b) (mattress vs. cushion), and venous leg ulcer will be based on compression (2c)(Low: \<10 mmHG vs. High: \>=30mmHG). Randomization will proceed within strata according to a permuted block scheme with a block size, or balancing interval, varying randomly between 2, 4 or 6. The primary endpoint will be evaluated by a blinded physician to avoid the bias. Total duration of each patient in the study is expected to be 20 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Wound Closure
Time Frame: 20 weeks
The primary objective of this trial is to evaluate increasing the proportion of wounds with complete closure within 20 weeks of initial treatment