Clinical trial NCT02802995: Safety And Efficacy Of Topical Platelet Rich Plasma And Thrombin Coagulum
Official title: Safety And Efficacy Of Topical Platelet Rich Plasma And Thrombin Coagulum In The Treatment Of Recalcitrant Venous Stasis Ulcers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Stasis Ulcer
Lead sponsor: University of Witwatersrand, South Africa
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility 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

Primary outcomes:
measure: Size of the wound treated with the PRP/thrombin mixture
timeFrame: 12 weeks
measure: Number and type adverse events
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Charlotte Maxeke Johannesburg Academic Hospital
state: Gauteng
Study officials:
affiliation: Univeristy of the Witwatersrand
name: Johnny Mahlangu, MBBCH, MMed
role: PRINCIPAL_INVESTIGATOR
References:
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