- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03857334
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
-
-
-
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
16 years to 58 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
|
|
Active Comparator: Arm B
|
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
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.
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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