Effectiveness of Autologous Platelet Rich Plasma in the Treatment of Chronic Non-Healing Wounds

Not Applicable

Terminated

• Conditions: Skin Ulcer Venous Stasis Chronic; Foot Ulcer Chronic; Pressure Ulcer
• Interventions: Procedure: Standard of Care; Procedure: Platelet Rich Plasma

• Registration Number: NCT02307448
• Lead Sponsor: ACR Biologics, LLC

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.

Study Timeline

• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2014-12-03
• Study First Posted: 2014-12-04
• Study Start: 2015-08
• Primary Completion: 2022-12
• Study Completion: 2022-12
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	Patients will receive weekly standard of care.
PRP Group	Platelet Rich Plasma	Patients will receive weekly PRP treatments

Primary Outcome Measures

Name	Time	Method
Wound Closure	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

Trial Locations

Locations (1)

TriHealth Hatton Research Institute | Bethesda North Hospital; 🇺🇸 Cincinnati, Ohio, United States