Fasciitis, PlantarHISTO-APSNCT06697834
Assessment of Pain in Plantar Fasciitis Managed by Histotripsy
A study testing Histotripsy ultrasound session, VAS questionnaire and AOFAS questionnaire in people with Fasciitis, Plantar and Aponeurosis Contusion, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Plantar fasciitis or plantar fasciitis is the most commonly reported cause of pain under the heel. Its prevalence varies from 3.6 to 7% in the general population. It is a painful condition of the foot that corresponds to an inflammation of the plantar fascia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fasciitis, Plantar, Aponeurosis Contusion
- What is being tested?
- Histotripsy ultrasound session, VAS questionnaire and AOFAS questionnaire
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 6 Dec 2023to 6 Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient, male or female, aged 18 years minimum
- Patient with plantar fasciitis evolving for at least 6 months
- Patients with radiology and MRI of the foot less than 3 months old
- Visual analogue pain scale greater than 5 at inclusion
- Patient in whom conventional medical treatment has failed by the combination of radial shock waves, plantar orthoses, and corticosteroid infiltration that has not provided relief.
- Patient affiliated with or beneficiary of a social security scheme.
- Patient who has been informed and has given his/her free, informed and written consent.
Who cannot join
- Minor patient
- Major retraction of the triceps surae on the MAESTRO oblique board test: sequelae of bone trauma to the hindfoot and ankle.
- Inflammatory rheumatological diseases
- Fibromyalgia
- Patients in whom a specific underlying organic pathology (inflammatory, infectious, neoplastic, etc.) has been identified.
- Psychiatric disorders
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- Patient participating in another research study.
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Pregnant, breastfeeding or parturient woman.
- Patient hospitalized without consent.
Trial locations and contacts
1 site in 1 country.
About this study
Plantar fasciitis or plantar fasciitis is the most commonly reported cause of pain under the heel. Its prevalence varies from 3.6 to 7% in the general population. It is a painful condition of the foot that corresponds to an inflammation of the plantar fascia.
At present, histotripsy in the field of orthopedics is very little used. The concept of therapeutic ultrasound intended for the treatment of plantar fasciitis by fascial section was developed in the United States but no study evaluating its effects on pain is available.
Read more
There is no equivalent study on histotripsy in the pathology of chronic plantar fasciitis or fasciitis. In this study, histotripsy will be performed using a conventional serial ultrasound system with this focused energy function.
The research hypothesis is that histotripsy treatment may be an alternative to pain management in patients with plantar fasciitis who have failed conventional treatments.
The main objective of this study is to evaluate the evolution of the pain felt by patients with plantar fasciitis resistant to conventional medical treatment, one month after two ultrasound histotripsy sessions.
- Conditions
- Fasciitis, Plantar, Aponeurosis Contusion
- Being tested
- Histotripsy ultrasound session, VAS questionnaire, AOFAS questionnaire
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Histotripsy ultrasound sessionProcedure or surgery
The study will be performed with the MINDRAY DP-10 ultrasound device equipped with a linear probe and histotripsy functionality.
VAS questionnaireOther
Pain assessment with the EVA questionnaire
AOFAS questionnaireOther
AOFAS questionnaire at visit 1 and visit 4 (75 days after the first visit).
| Study group | Role | What they receive |
|---|---|---|
| Patient with plantar fasciitis | Experimental | Not described Receives: Procedure: Histotripsy ultrasound session; Other: VAS questionnaire; Other: AOFAS questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of change in pain (VAS 0-10)
the percentage of change in pain (VAS 0-10) felt 1 month after two ultrasound histotripsy sessions (visit 4) compared to the baseline value (visit 1).
Measured: 1 month and a half
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start6 Dec 2023
- Primary completion6 May 2024
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fasciitis, PlantarStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697834
- Sponsor's protocol ID
- 2023-A01296-39
- Acronym
- HISTO-APS
- Status last verified
- Jul 2026
- First submitted
- 18 Nov 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pain in Plantar Fasciitis Managed by Histotripsy
- ClinicalTrials.gov ID
- NCT06697834
- Acronym / sponsor ID
- HISTO-APS / 2023-A01296-39
- Conditions
- Fasciitis, Plantar, Aponeurosis Contusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 20 Nov 2024 (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 or plantar fasciitis is the most commonly reported cause of pain under the heel. Its prevalence varies from 3.6 to 7% in the general population. It is a painful condition of the foot that corresponds to an inflammation of the plantar fascia.
At present, histotripsy in the field of orthopedics is very little used. The concept of therapeutic ultrasound intended for the treatment of plantar fasciitis by fascial section was developed in the United States but no study evaluating its effects on pain is available.
There is no equivalent study on histotripsy in the pathology of chronic plantar fasciitis or fasciitis. In this study, histotripsy will be performed using a conventional serial ultrasound system with this focused energy function.
The research hypothesis is that histotripsy treatment may be an alternative to pain management in patients with plantar fasciitis who have failed conventional treatments.
The main objective of this study is to evaluate the evolution of the pain felt by patients with plantar fasciitis resistant to conventional medical treatment, one month after two ultrasound histotripsy sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with plantar fasciitis | Experimental | Procedure: Histotripsy ultrasound session, Other: VAS questionnaire, Other: AOFAS questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient, male or female, aged 18 years minimum
- Patient with plantar fasciitis evolving for at least 6 months
- Patients with radiology and MRI of the foot less than 3 months old
- Visual analogue pain scale greater than 5 at inclusion
- Patient in whom conventional medical treatment has failed by the combination of radial shock waves, plantar orthoses, and corticosteroid infiltration that has not provided relief.
Key exclusion criteria (10 listed)
- Minor patient
- Major retraction of the triceps surae on the MAESTRO oblique board test: sequelae of bone trauma to the hindfoot and ankle.
- Inflammatory rheumatological diseases
- Fibromyalgia
- Patients in whom a specific underlying organic pathology (inflammatory, infectious, neoplastic, etc.) has been identified.
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 |
|---|---|---|
| Histotripsy ultrasound sessionThe study will be performed with the MINDRAY DP-10 ultrasound device equipped with a linear probe and histotripsy functionality. | Procedure or surgery | Patient with plantar fasciitis |
| VAS questionnairePain assessment with the EVA questionnaire | Other | Patient with plantar fasciitis |
| AOFAS questionnaireAOFAS questionnaire at visit 1 and visit 4 (75 days after the first visit). | Other | Patient with plantar fasciitis |
Primary outcome
the percentage of change in pain (VAS 0-10)
Time frame: 1 month and a half
the percentage of change in pain (VAS 0-10) felt 1 month after two ultrasound histotripsy sessions (visit 4) compared to the baseline value (visit 1).
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 16 Jul 2026.
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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 Histotripsy ultrasound session, VAS questionnaire and AOFAS questionnaire in people with Fasciitis, Plantar and Aponeurosis Contusion, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 7 inclusion and 10 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 16 Jul 2026. 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?
the percentage of change in pain (VAS 0-10) (time frame: 1 month and a half). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2026.