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

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.

Conditions

• Diabetic Foot Ulcers
• Venous Ulcers
• Pressure Ulcers

Interventions

DEVICE

Autologous PRP Gel

Autologous PRP Gel is prepared using the Arteriocyte Magellan® System (510(k) approved), an Autologous Platelet Separator Instrument, which is a microprocessor-controlled centrifuge designed to be used in the clinical laboratory or intraoperatively at point of care for the safe and rapid preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of blood. The Arteriocyte Magellan® automatically and quickly separates PRP from anticoagulated blood and dispenses it into a separate sterile syringe. The prepared PRP is then activated (by mixing with thrombin and calcium chloride) and sprayed directly on the area to be treated.

DEVICE

Autologous PRP Injections

Autologous PRP Gel is prepared using the Arteriocyte Magellan® System (510(k) approved), an Autologous Platelet Separator Instrument, which is a microprocessor-controlled centrifuge designed to be used in the clinical laboratory or intraoperatively at point of care for the safe and rapid preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of blood. The Arteriocyte Magellan® automatically and quickly separates PRP from anticoagulated blood and dispenses it into a separate sterile syringe. The prepared PRP is then drawn into multiple small syringes and injected directly into the wound bed or the skin surrounding it.

DEVICE

Autologous PRP Gel plus PRP Injections

Autologous PRP Gel is prepared using the Arteriocyte Magellan® System (510(k) approved), an Autologous Platelet Separator Instrument, which is a microprocessor-controlled centrifuge designed to be used in the clinical laboratory or intraoperatively at point of care for the safe and rapid preparation of platelet poor plasma and PRP from a small sample of blood. The Arteriocyte Magellan® automatically and quickly separates PRP from anticoagulated blood and dispenses it into a separate sterile syringe. The prepared PRP is then divided into equal parts and half is drawn into multiple small syringes and injected directly into the skin surrounding the wound bed, half is activated (by mixing with thrombin and calcium chloride) and sprayed the wound bed.

PROCEDURE

Standard Wound Care

Subjects in the control group will receive Standard Wound Care treatment for chronic wounds according to accepted medical practices.

Sponsors & Collaborators

• Arteriocyte, Inc.

  lead INDUSTRY

Principal Investigators

• Brittany Hamilton · Compass Biomedical (Formerly Arteriocyte, Inc.)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-04-30

Primary Completion

2018-01-31

Countries

• United States

Study Locations