Safety And Efficacy Of Topical Platelet Rich Plasma And Thrombin Coagulum

October 24, 2017 updated by: Johnny Mahlangu, University of Witwatersrand, South Africa

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Charlotte Maxeke Johannesburg Academic Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • thrombostim
No Intervention: Control arm
Subjects receiving the standard of care for chronic venous wounds

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks
Number and type adverse events
Time Frame: 12 weeks
Adverse events will reported at the start and throughout the treatment period
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Witwatersrand, South Africa

Investigators

  • Principal Investigator: Johnny Mahlangu, MBBCH, MMed, Univeristy of the Witwatersrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

June 13, 2016

First Posted (Estimate)

June 16, 2016

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BDU005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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