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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Mixture of platelet rich plasma and thrombin applied topically on the wound surface
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, South Africa
Size of the wound treated with the PRP/thrombin mixture
Size of the wound will be measured at the end of the study
Time frame: 12 weeks
Number and type adverse events
Adverse events will reported at the start and throughout the treatment period
Time frame: 12 weeks
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