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

NATerminatedINTERVENTIONAL
Enrollment

1,500

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

January 31, 2018

Conditions
Diabetic Foot UlcersVenous UlcersPressure 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.

Trial Locations (6)

11042

Comprehensive Wound Healing Center and Hyperbarics, Lake Success

15009

Heritage Valley Health System, Beaver

44107

Total Foot Care, Cleveland

83404

Sunnyside Foot and Ankle, Idaho Falls

93313

Good Samaritan Wound Care Center, Bakersfield

07631

Wound Care Center, Englewood Hospital and Medical Center, Englewood

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Arteriocyte, Inc.

INDUSTRY

NCT02071979 - Registry Trial of the Effectiveness of Platelet Rich Plasma for Chronic Non-Healing Wounds | Biotech Hunter | Biotech Hunter