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Safety And Efficacy Of Topical Platelet Rich Plasma And Thrombin Coagulum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02802995
Recruitment Status : Terminated (Resource issue)
First Posted : June 16, 2016
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Johnny Mahlangu, University of Witwatersrand, South Africa

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

Condition or disease Intervention/treatment Phase
Stasis Ulcer Drug: PRP/thrombin mixture Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety And Efficacy Of Topical Platelet Rich Plasma And Thrombin Coagulum In The Treatment Of Recalcitrant Venous Stasis Ulcers
Study Start Date : May 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment arm
Subjects receiving the study drug which is PRP/thrombin mixture
Drug: PRP/thrombin mixture
Mixture of platelet rich plasma and thrombin applied topically on the wound surface
Other Name: thrombostim

No Intervention: Control arm
Subjects receiving the standard of care for chronic venous wounds



Primary Outcome Measures :
  1. Size of the wound treated with the PRP/thrombin mixture [ Time Frame: 12 weeks ]
    Size of the wound will be measured at the end of the study

  2. Number and type adverse events [ Time Frame: 12 weeks ]
    Adverse events will reported at the start and throughout the treatment period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802995


Locations
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South Africa
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, South Africa, 2193
Sponsors and Collaborators
University of Witwatersrand, South Africa
Investigators
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Principal Investigator: Johnny Mahlangu, MBBCH, MMed Univeristy of the Witwatersrand
Publications of Results:
Other Publications:

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Responsible Party: Johnny Mahlangu, Professor, University of Witwatersrand, South Africa
ClinicalTrials.gov Identifier: NCT02802995    
Other Study ID Numbers: BDU005
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Varicose Ulcer
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Thrombin
Hemostatics
Coagulants