NCT02802995

Safety And Efficacy Of Topical Platelet Rich Plasma And Thrombin Coagulum

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Witwatersrand, South Africa · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Stasis Ulcer

Interventions

Type	Name	Description
DRUG	PRP/thrombin mixture	Mixture of platelet rich plasma and thrombin applied topically on the wound surface

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2016-06-16
• Last updated: 2017-10-26

Locations

1 site across 1 country: South Africa