Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-27 @ 9:31 PM
Study NCT ID:
NCT02802995
Status:
TERMINATED
Last Update Posted:
2017-10-26
First Post:
2016-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety And Efficacy Of Topical Platelet Rich Plasma And Thrombin Coagulum
Sponsor:
University of Witwatersrand, South Africa
Organization:
Study Overview
Official Title:
Safety And Efficacy Of Topical Platelet Rich Plasma And Thrombin Coagulum In The Treatment Of Recalcitrant Venous Stasis Ulcers
Status:
TERMINATED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Resource issue
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
* 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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: