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Autologous Platelet Rich Plasma (PRP) for the Treatment of Chronic Non-Healing Ulcers

NCT03026855 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-01-20

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of autologous PRP injection in combination with topical application of PRP gel in treating chronic or non-healing ulcers on lower extremity using a rapid, intra-operative, point-of-care technology at the patient's bedside.

Conditions

  • Chronic Ulcer

Interventions

BIOLOGICAL

Autologous PRP Gel and PRP Injection

Autologous PRP prepared using the Res-Q™ 60 PRP system from patient's whole blood, will be injected subcutaneously around the periphery of the wound/ulcer. Based on the wound size and area, autologous platelet gel obtained by spraying simultaneously equal volumes of PRP and activator solution (thrombin with calcium chloride) will be applied topically over the ulcer or wound. Single dose of PRP injections and application of PRP gel will be administered, only on the day of treatment.

Sponsors & Collaborators

  • TotipotentRX Cell Therapy Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Dr. Suhail N Bukhari, MBBS, DNB · Fortis Escorts Heart Institute and Research Centre

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-04-30
Completion
2016-05-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03026855 on ClinicalTrials.gov