Safety And Efficacy Of Topical Platelet Rich Plasma And Thrombin Coagulum

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Stasis Ulcer

Intervention / Treatment
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* Drug: PRP/thrombin mixture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>Subjects receiving the study drug which is PRP/thrombin mixture | Drug: PRP/thrombin mixture<br>* Mixture of platelet rich plasma and thrombin applied topically on the wound surface<br>* Other names: thrombostim;|
| No Intervention: Control arm<br>Subjects receiving the standard of care for chronic venous wounds | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of the wound treated with the PRP/thrombin mixture | Size of the wound will be measured at the end of the study | 12 weeks | 
| Number and type adverse events | Adverse events will reported at the start and throughout the treatment period | 12 weeks |