Safety And Efficacy Of Topical Platelet Rich Plasma And Thrombin Coagulum

• Status: Terminated
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Witwatersrand, South Africa
• Treatments: Thrombin

Criteria

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