Efficacy of Platelet Rich Plasma in Plantar Fasciitis (APOPLANT)

February 26, 2019 updated by: University Hospital, Montpellier

Plantar Fasciitis Treatment: Double Blinded Randomized Control Study of the Efficacy of an Injection of Platelet Rich Plasma (PRP) Versus an Infiltration of Corticosteroids

Plantar fasciitis is a common pathology among podiatry moreover the healing time takes several months.

The main aim of this study is to evaluate the efficacy of a injection of Platelet-Rich Plasma (PRP) versus corticosteroid injection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

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

  • France
      • Montpellier, France, 34090
        • Montpellier University Hosîtal

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

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Plantar fasciitis
  • Average VAS greater than or equal to 5/10
  • Resistance of medical reference treatment

Exclusion Criteria:

  • Other plantar lesion find on RMI
  • Pregnancy

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Biological: Injection of autologous platelet rich plasma
Active Comparator: Arm B
Drug: Injection of cortivazol : Altim®
Corticosteroids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean daily pain measured with a visual analog scale from 0 to 10
Time Frame: 6 months
Comparison of pain intensity, measured with a visual analog scale from 0 to 10
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity during the first steps of the day measured with a visual analog scale from 0 to 10
Time Frame: 6 months
Measured with a visual analog scale from 0 to 10
6 months
Pain intensity on direct compression measured with a visual analog scale from 0 to 10
Time Frame: 6 months
Constant intensity of the compression, measured with a visual analog scale from 0 to 10
6 months
Impairment of walking function
Time Frame: 6 months
Foot function index
6 months

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

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 (Actual)

July 1, 2016

Primary Completion (Actual)

October 18, 2017

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

April 27, 2018

First Submitted That Met QC Criteria

February 26, 2019

First Posted (Actual)

February 27, 2019

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF 8737

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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