Plantar FascitisAPOPLANTNCT03857334
Efficacy of Platelet Rich Plasma in Plantar Fasciitis
A study testing Injection of autologous platelet rich plasma and Injection of cortivazol : Altim® in people with Plantar Fascitis, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- Injection of autologous platelet rich plasma and Injection of cortivazol : Altim®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2016to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Plantar fasciitis
- Average VAS greater than or equal to 5/10
- Resistance of medical reference treatment
Who cannot join
- Other plantar lesion find on RMI
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Plantar Fascitis
- Being tested
- Injection of autologous platelet rich plasma, Injection of cortivazol : Altim®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of autologous platelet rich plasmaBiological
Injection of cortivazol : Altim®Drug
Corticosteroids
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Biological: Injection of autologous platelet rich plasma |
| Arm B | Active comparator | Not described Receives: Drug: Injection of cortivazol : Altim® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
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
Measured: 6 months
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
Measured: 6 months
Impairment of walking function
Foot function index
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start1 Jul 2016
- Primary completion18 Oct 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857334
- Sponsor's protocol ID
- UF 8737
- Acronym
- APOPLANT
- Status last verified
- Feb 2019
- First submitted
- 27 Apr 2018
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34844893
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03857334
- Acronym / sponsor ID
- APOPLANT / UF 8737
- Conditions
- Plantar Fascitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 18 Oct 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Biological: Injection of autologous platelet rich plasma |
| Arm B | Active comparator | Drug: Injection of cortivazol : Altim® |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Plantar fasciitis
- Average VAS greater than or equal to 5/10
- Resistance of medical reference treatment
Key exclusion criteria (2 listed)
- Other plantar lesion find on RMI
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of autologous platelet rich plasma | Biological | Arm A |
| Injection of cortivazol : Altim®Corticosteroids | Drug | Arm B |
Primary outcome
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
3 secondary outcomes
Pain intensity during the first steps of the day measured with a visual analog scale from 0 to 10
Time frame: 6 months
Pain intensity on direct compression measured with a visual analog scale from 0 to 10
Time frame: 6 months
Impairment of walking function
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Derived from this study: PubMed 34844893Breton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of autologous platelet rich plasma and Injection of cortivazol : Altim® in people with Plantar Fascitis, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean daily pain measured with a visual analog scale from 0 to 10 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03857334, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.