Safety And Efficacy Of Topical Platelet Rich Plasma And Thrombin Coagulum

University of Witwatersrand

Status and phase

Terminated

Phase 3

Conditions

Stasis Ulcer

Treatments

Drug: PRP/thrombin mixture

Study type

Interventional

Funder types

Other

Identifiers

NCT02802995

BDU005

Details and patient eligibility

About

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

Full 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

Enrollment

15 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Willing and able to give written informed consent
Age 18 years to 75 years.
Both males and females.
Ankle branchial index of 0.8 or above.

Exclusion criteria

Diabetics will be excluded as the Ankle Branchial Index (ABI) result is considered an unreliable due the possible presence of arteriosclerotic plaques (lead pipe rigidity).
Patients who have participated in experimental drug studies within 30 days of entering this study.
receiving chemotherapy or radiotherapy for malignant diseases or any other indication
Patients taking corticosteroids or other immunosuppressive medications
Clinically malnourished patients or those with recent (last 4 weeks without treatment) serum albumin of less than 30g/l.
Patients with current or past history of acute deep vein thrombosis.
Patients with current signs and/or symptoms of cardiac, renal or hepatic failure. Renal failure defines as Creatinine
Patients with signs and/or symptoms of peripheral neuropathy.
Patients with signs and/or symptoms of ATROPHIE BLANCHE or other conditions associated with non-chronic venous insufficiency ulceration of the lower leg.
Patients with signs and/or symptoms of immunocompromized sates or recent (last 4 weeks ) T cell subset (CD4) count of less than 200 cells / ml.
Patients showing clinical signs and/or symptoms of anaemia or current or recent(last 4 weeks without treatment) haemoglobin level of less than 8g/dl