NCT03857334

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

1.3 years

First QC Date

April 27, 2018

Last Update Submit

February 26, 2019

Conditions

Plantar Fascitis

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (3)

  • Pain intensity during the first steps of the day 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

    6 months

  • Impairment of walking function

    6 months

Study Arms (2)

Arm A

EXPERIMENTAL
Biological: Injection of autologous platelet rich plasma

Arm B

ACTIVE COMPARATOR
Drug: Injection of cortivazol : Altim®

Interventions

Injection of autologous platelet rich plasmaBIOLOGICAL
Arm A
Injection of cortivazol : Altim®DRUG

Corticosteroids

Arm B

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Other plantar lesion find on RMI
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montpellier University Hosîtal

Montpellier, 34090, France

Location

Related Publications (1)

  • 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.

    PMID: 34844893DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2018

First Posted

February 27, 2019

Study Start

July 1, 2016

Primary Completion

October 18, 2017

Study Completion

December 31, 2018

Last Updated

February 27, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)