Autologous Platelet Rich Plasma (PRP) for the Treatment of Chronic Non-Healing Ulcers

Chronic Ulcer Clinical Trial

Official title: To Demonstrate the Safety and Efficacy of Autologous Platelet Rich Plasma (PRP) for the Treatment of Chronic Non-Healing Ulcers

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of autologous PRP injection in combination with topical application of PRP gel in treating chronic or non-healing ulcers on lower extremity using a rapid, intra-operative, point-of-care technology at the patient's bedside.

Clinical Trial Description

Platelet Rich Plasma (PRP) therapy is an innovative treatment that uses body's own cells to relieve pain and promote accelerated healing of Non-healing Foot Ulcer /Wound. The body's response to any tissue injury is to deliver platelets, which play an instrumental role in the normal healing process by secreting growth factors and attracting stem cells—critical components of the healing cascade.

Any wound or ulcer on skin that has been present for 4-5 weeks duration, without healing is called a non-healing ulcer. Non-healing ulcers include venous, arterial, diabetic, pressure and traumatic ulcers. Cellular therapies using Autologous Platelet Rich Plasma provides new options for wound healing. The efficacy of the treatment has been proven in surgical applications, in the treatment of severe burns and in transplantation of cells and tissues.

Local application of a solution of plasma enriched in platelets derived from the patient's blood intends to trigger the healing process in non-responsive chronic wound, increase the wound repair rate and reduce pain. PRP is a good option for non-healing wounds because it utilizes the body's natural healing processes to jump-start wound healing. Plasma which contains very valuable growth factors is separated from other blood components utilizing a point of care technology based on density gradient centrifugation. The platelet rich plasma is harvested and then activated by a mixture of human thrombin and calcium chloride for initiating the healing cascade followed by PRP injection directly into the ulcer/wound periphery or spread over a wound in the form of a PRP gel. ;

Related Conditions & MeSH terms

• Chronic Ulcer
• Ulcer

• NCT number: NCT03026855
• Study type: Interventional
• Source: TotipotentRX Cell Therapy Pvt. Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: June 2014
• Completion date: May 2016