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

NCT02307448 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-02-01

No results posted yet for this study

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.

Conditions

  • Foot Ulcer Chronic
  • Skin Ulcer Venous Stasis Chronic
  • Pressure Ulcer

Interventions

PROCEDURE

Platelet Rich Plasma

Patients will receive weekly PRP treatments with standard of care.

PROCEDURE

Standard of Care

Patients will receive weekly standard of care.

Sponsors & Collaborators

  • ACR Biologics, LLC

    lead INDUSTRY

Principal Investigators

  • Louis Thibodeaux, MD,FACCWS · TriHealth Hatton Research Institute | Bethesda North Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02307448 on ClinicalTrials.gov