Safety And Efficacy Of Topical Platelet Rich Plasma And Thrombin Coagulum

Stasis Ulcer Clinical Trial

Official title: Safety And Efficacy Of Topical Platelet Rich Plasma And Thrombin Coagulum In The Treatment Of Recalcitrant Venous Stasis Ulcers

Status Terminated

Clinical Trial Summary

The aim of this study is to

• To evaluate the safety and tolerability of Platelet Rich plasma(PRP)/Thrombin mixture in treating chronic venous ulcers

• To evaluate efficacy of PRP/Thrombin mixture in treating chronic venous ulcers

Clinical Trial Description

Study rationale

In normal wound healing, platelets activate macrophages to produce endogenous platelet derived growth factor (PDGF) and other growth factors which are responsible for would healing. In chronic wounds, macrophage activation is suppressed which leads to an inappropriate growth factor response causing failure of positive autocrine feedback loop which normally controls the healing process. The regular application of exogenous PRP and Thrombin, to chronic wounds, restores the autocrine feedback loop of tissue repair which appears to accelerate the normal cascade of tissue repair

Objectives

• To evaluate the safety and tolerability of PRP/Thrombin mixture in treating chronic venous ulcers

• To evaluate efficacy of PRP/Thrombin mixture in treating chronic venous ulcers ;

Related Conditions & MeSH terms

• Stasis Ulcer
• Varicose Ulcer

• NCT number: NCT02802995
• Study type: Interventional
• Source: University of Witwatersrand, South Africa
• Status: Terminated
• Phase: Phase 3
• Start date: May 2016
• Completion date: May 2017