Plantar FasciitisREGAPOPNCT07060352
Estimating the Prevalence of GAstrocnemius Muscle REtraction in a Population Suffering From Plantar aPOneurositis and Describing the Effects of Lengthening
A study testing Ankle Dorsiflexion Index (ADI) measurement in people with Plantar Fasciitis, run by Clinique Saint Charles.
Trial summary
The gastrocnemius muscles, which form the upper part of the calf, can suffer from retraction, a common but often under-diagnosed condition, which can be a risk factor for plantar fasciitis. Retraction can be treated medically, by stretching, or surgically, by lengthening the muscles. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Ankle Dorsiflexion Index (ADI) measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 70 or under
- Patient suffering from unilateral plantar fasciitis that has progressed for more than 6 months and is recalcitrant to medical treatment
- Collection of express, oral consent
- Available for follow-up visits
Who cannot join
- Patients with neuropathic pain
- History of fracture of the lower limb, surgery on the lower limb, inflammatory rheumatism of the lower limb, injury to the Achilles tendon
- Patient with another painful orthopedic lesion of the legs/feet
- Patient with surgically treated plantar fasciitis in the year prior to inclusion
- Persons unable to give consent
- Not affiliated to a social security scheme
- Persons under court protection
- Participant in another study with an ongoing exclusion period
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The gastrocnemius muscles, which form the upper part of the calf, can suffer from retraction, a common but often under-diagnosed condition, which can be a risk factor for plantar fasciitis. Retraction can be treated medically, by stretching, or surgically, by lengthening the muscles. Gastrocnemius retraction is difficult to measure, but tests such as the Ankle Dorsiflexion Index (ADI) provide a more accurate assessment.
Knowing the prevalence of this retraction in patients suffering from plantar fasciitis would enable us to improve diagnostic criteria and better target treatments. Surgical lengthening of the gastrocnemius, particularly by tenotomy, is effective in cases of chronic plantar fasciitis, even without apparent muscle retraction.
- Conditions
- Plantar Fasciitis
- Being tested
- Ankle Dorsiflexion Index (ADI) measurement
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle Dorsiflexion Index (ADI) measurementDiagnostic test
Ankle Dorsiflexion Index (ADI) measurement at D0 and W8
| Study group | Role | What they receive |
|---|---|---|
| Ankle Dorsiflexion Index (ADI) measurement | Experimental | Ankle Dorsiflexion Index (ADI) measurement at D0 and W8 Receives: Diagnostic Test: Ankle Dorsiflexion Index (ADI) measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of gastrocnemius muscle retraction in patients with plantar fasciitis
retraction of the gastrocnemius muscles will be defined by an ADI of less than 13° measured by a digital inclinometer
Measured: At Day 0
Secondary outcomes (12)
correlation between ADI measurement and Manchester Oxford Foot Questionnaire (MOXFQ)
The Manchester Oxford Foot Questionnaire (MOXFQ) is used to measure the impact of foot pain on patients' quality of life. It consists of 16 questions. The raw scores of the scales are converted into a metric scale ranging from 0 to 100, where 100 indicates the maximum intensity of suffering or limitation.
Measured: At Day 0
correlation between ADI measurement and pain Visual Analog Scale (VAS)
The VAS consists of a straight line where one extreme represents the total absence of pain and the other extreme, the most intense pain possible. Patients are asked to mark on this line the level of pain they feel at any given moment. Pain intensity is then measured according to the distance between the start of the scale (0) and the point where the patient placed his mark:
- 0 cm (or the start of the scale): No pain
- 10 cm (or the end of the scale): Maximum imaginable pain
Measured: At Day 0
Evolution of Visual Analog Scale (VAS)
The VAS consists of a straight line where one extreme represents the total absence of pain and the other extreme, the most intense pain possible. Patients are asked to mark on this line the level of pain they feel at any given moment. Pain intensity is then measured according to the distance between the start of the scale (0) and the point where the patient placed his mark: - 0 cm (or the start of the scale): No pain - 10 cm (or the end of the scale): Maximum imaginable pain
Measured: between Day 0 and Week 8
Evolution of Visual Analog Scale (VAS)
The VAS consists of a straight line where one extreme represents the total absence of pain and the other extreme, the most intense pain possible. Patients are asked to mark on this line the level of pain they feel at any given moment. Pain intensity is then measured according to the distance between the start of the scale (0) and the point where the patient placed his mark: - 0 cm (or the start of the scale): No pain - 10 cm (or the end of the scale): Maximum imaginable pain
Measured: between Day 0 and Week 16
Evolution of Visual Analog Scale (VAS)
The VAS consists of a straight line where one extreme represents the total absence of pain and the other extreme, the most intense pain possible. Patients are asked to mark on this line the level of pain they feel at any given moment. Pain intensity is then measured according to the distance between the start of the scale (0) and the point where the patient placed his mark: - 0 cm (or the start of the scale): No pain - 10 cm (or the end of the scale): Maximum imaginable pain
Measured: between Day0 and Week 24
Evolution of Manchester Oxford Foot Questionnaire (MOXFQ)
The Manchester Oxford Foot Questionnaire (MOXFQ) is used to measure the impact of foot pain on patients' quality of life. It consists of 16 questions. The raw scores of the scales are converted into a metric scale ranging from 0 to 100, where 100 indicates the maximum intensity of suffering or limitation.
Measured: between Day 0 and Week 8
Evolution of Manchester Oxford Foot Questionnaire (MOXFQ)
The Manchester Oxford Foot Questionnaire (MOXFQ) is used to measure the impact of foot pain on patients' quality of life. It consists of 16 questions. The raw scores of the scales are converted into a metric scale ranging from 0 to 100, where 100 indicates the maximum intensity of suffering or limitation.
Measured: between Day 0 and Week 16
Evolution of Manchester Oxford Foot Questionnaire (MOXFQ)
The Manchester Oxford Foot Questionnaire (MOXFQ) is used to measure the impact of foot pain on patients' quality of life. It consists of 16 questions. The raw scores of the scales are converted into a metric scale ranging from 0 to 100, where 100 indicates the maximum intensity of suffering or limitation.
Measured: between Day 0 and Week 24
Correlation between surgical success and body mass index (BMI)
Surgical success is based on variation of pain (mesured with Visual Analogic Scale)
Measured: At Day 0
Correlation between surgical success and age of patient
Surgical success is based on variation of pain (mesured with Visual Analogic Scale)
Measured: At Day 0
Correlation between surgical success and tobacco consumption
Surgical success is based on variation of pain (mesured with Visual Analogic Scale)
Measured: At Day 0
Correlation between surgical success and location of fasciitis
Surgical success is based on variation of pain (mesured with Visual Analogic Scale) Location of fasciitis: proximal or central
Measured: At Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Saint Charles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060352
- Sponsor's protocol ID
- REGAPOP
- Other IDs
- 2025-A00798-41
- Acronym
- REGAPOP
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimating the Prevalence of GAstrocnemius Muscle REtraction in a Population Suffering From Plantar aPOneurositis and Describing the Effects of Lengthening
- ClinicalTrials.gov ID
- NCT07060352
- Acronym / sponsor ID
- REGAPOP / REGAPOP
- Conditions
- Plantar Fasciitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Clinique Saint CharlesUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 11 Jul 2025 (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.
The gastrocnemius muscles, which form the upper part of the calf, can suffer from retraction, a common but often under-diagnosed condition, which can be a risk factor for plantar fasciitis. Retraction can be treated medically, by stretching, or surgically, by lengthening the muscles. Gastrocnemius retraction is difficult to measure, but tests such as the Ankle Dorsiflexion Index (ADI) provide a more accurate assessment.
Knowing the prevalence of this retraction in patients suffering from plantar fasciitis would enable us to improve diagnostic criteria and better target treatments. Surgical lengthening of the gastrocnemius, particularly by tenotomy, is effective in cases of chronic plantar fasciitis, even without apparent muscle retraction.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ankle Dorsiflexion Index (ADI) measurement | Experimental | Diagnostic Test: Ankle Dorsiflexion Index (ADI) measurementAnkle Dorsiflexion Index (ADI) measurement at D0 and W8 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient aged 70 or under
- Patient suffering from unilateral plantar fasciitis that has progressed for more than 6 months and is recalcitrant to medical treatment
- Collection of express, oral consent
- Available for follow-up visits
Key exclusion criteria (8 listed)
- Patients with neuropathic pain
- History of fracture of the lower limb, surgery on the lower limb, inflammatory rheumatism of the lower limb, injury to the Achilles tendon
- Patient with another painful orthopedic lesion of the legs/feet
- Patient with surgically treated plantar fasciitis in the year prior to inclusion
- Persons unable to give consent
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 |
|---|---|---|
| Ankle Dorsiflexion Index (ADI) measurementAnkle Dorsiflexion Index (ADI) measurement at D0 and W8 | Diagnostic test | Ankle Dorsiflexion Index (ADI) measurement |
Primary outcome
Prevalence of gastrocnemius muscle retraction in patients with plantar fasciitis
Time frame: At Day 0
retraction of the gastrocnemius muscles will be defined by an ADI of less than 13° measured by a digital inclinometer
12 secondary outcomes
correlation between ADI measurement and Manchester Oxford Foot Questionnaire (MOXFQ)
Time frame: At Day 0
correlation between ADI measurement and pain Visual Analog Scale (VAS)
Time frame: At Day 0
Evolution of Visual Analog Scale (VAS)
Time frame: between Day 0 and Week 8
Evolution of Visual Analog Scale (VAS)
Time frame: between Day 0 and Week 16
Evolution of Visual Analog Scale (VAS)
Time frame: between Day0 and Week 24
Evolution of Manchester Oxford Foot Questionnaire (MOXFQ)
Time frame: between Day 0 and Week 8
Evolution of Manchester Oxford Foot Questionnaire (MOXFQ)
Time frame: between Day 0 and Week 16
Evolution of Manchester Oxford Foot Questionnaire (MOXFQ)
Time frame: between Day 0 and Week 24
Correlation between surgical success and body mass index (BMI)
Time frame: At Day 0
Correlation between surgical success and age of patient
Time frame: At Day 0
Correlation between surgical success and tobacco consumption
Time frame: At Day 0
Correlation between surgical success and location of fasciitis
Time frame: At Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle Dorsiflexion Index (ADI) measurement in people with Plantar Fasciitis, run by Clinique Saint Charles.
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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timothée BISSUEL, MD (+334 78 27 07 97, drtimothee.bissuel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of gastrocnemius muscle retraction in patients with plantar fasciitis (time frame: At Day 0). 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 11 Jul 2025.