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Efficacy of Platelet Rich Plasma in Plantar Fasciitis (APOPLANT)

Primary Purpose

Plantar Fascitis

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Injection of autologous platelet rich plasma

Injection of cortivazol : Altim®

About this trial

This is an interventional supportive care trial for Plantar Fascitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Montpellier University Hosîtal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

Outcomes

Primary Outcome Measures

Mean daily pain measured with a visual analog scale from 0 to 10

Comparison of pain intensity, measured with a visual analog scale from 0 to 10

Secondary Outcome Measures

Pain intensity during the first steps of the day measured with a visual analog scale from 0 to 10

Measured with a visual analog scale from 0 to 10

Pain intensity on direct compression measured with a visual analog scale from 0 to 10

Constant intensity of the compression, measured with a visual analog scale from 0 to 10

Impairment of walking function

Foot function index

Full Information

NCT ID

NCT03857334

First Posted

April 27, 2018

Last Updated

February 26, 2019

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT03857334

Brief Title

Efficacy of Platelet Rich Plasma in Plantar Fasciitis

Acronym

APOPLANT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

July 1, 2016 (Actual)

Primary Completion Date

October 18, 2017 (Actual)

Study Completion Date

December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plantar Fascitis

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Title

Arm B

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

Injection of autologous platelet rich plasma

Intervention Type

Drug

Intervention Name(s)

Injection of cortivazol : Altim®

Intervention Description

Corticosteroids

Primary Outcome Measure Information:

Title

Mean daily pain measured with a visual analog scale from 0 to 10

Description

Comparison of pain intensity, measured with a visual analog scale from 0 to 10

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Pain intensity during the first steps of the day measured with a visual analog scale from 0 to 10

Description

Measured with a visual analog scale from 0 to 10

Time Frame

6 months

Title

Pain intensity on direct compression measured with a visual analog scale from 0 to 10

Description

Constant intensity of the compression, measured with a visual analog scale from 0 to 10

Time Frame

6 months

Title

Impairment of walking function

Description

Foot function index

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Montpellier University Hosîtal

City

Montpellier

ZIP/Postal Code

34090

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34844893

Citation

Breton A, Leplat C, Picot MC, Aouinti S, Taourel P, Laffont I, Julia M, Cyteval C. Prediction of clinical response to corticosteroid or platelet-rich plasma injection in plantar fasciitis with MRI: A prospective, randomized, double-blinded study. Diagn Interv Imaging. 2022 Apr;103(4):217-224. doi: 10.1016/j.diii.2021.10.008. Epub 2021 Nov 26.

Results Reference

derived

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Efficacy of Platelet Rich Plasma in Plantar Fasciitis

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