Plantar FascitisANTILOPENCT05622279
Percutaneous Needle Tenotomy Associated With Platelet-rich Plasma Injection Platelet-rich Plasma in the Treatment of Refractory Plantar Fasciitis: a Pilot Study of the Effect on Pain and Tolerance
A study testing Percutaneous tenotomy + PRP in people with Plantar Fascitis, run by Nantes University Hospital at 1 site in France.
Trial summary
There are various treatments for plantar fasciitis, including physical therapy, orthopedic inserts or steroid infiltrations. However, it is estimated that about 20% of patients do not respond to first-line treatment [Rompe, Sports Med Arthrosc Rev, 2009]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- Percutaneous tenotomy + PRP
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2023to 11 Aug 2025
- 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 with chronic inferior heel pain diagnosed as plantar fasciitis plantar fasciitis evolving for more than 3 months with a pain VAS at activity ≥ 4/10
- Failure of the initial management including physical therapy, adaptation of footwear and local steroid infiltration
- Patient 18 years of age or older
- Patient affiliated to a social security plan
- Patient able to understand the protocol and having signed an informed informed consent
Who cannot join
- Patients on NSAIDs and refusing to discontinue them 1 week and 1 week after the procedure
- Corticosteroid infusion at the same lesion site in the last 3 months
- History of PRP injection at the same lesion site
- Treatment with antiplatelet agents [Acetylsalicylic acid (Aspegic, Kardegic, Duoplavin, Resitune, Asasantine), Clopidogrel (Plavix, Duoplavin), Dipyridamole (Persantine, Cleridium, Asasantine)]
- Coagulation disorders: thrombocytopenia < 150,000 platelets/mm3 - Patients on curative anticoagulants
- Any medical condition that may interfere with pain assessment
Show all 14Show fewer
- Current hematological disease or in remission for less than 5 years (hematological malignancies, myelodysplasia, autoimmune thrombocytopenia), chemotherapy
- Infection at the time of inclusion (bacterial infection and/or presence of fever and/or antibiotic treatment)
- Pregnant or breastfeeding women or those refusing effective contraception
- Patient deprived of liberty or under legal protection (guardianship or curatorship)
- Patients under court protection
- Patients participating in another clinical research protocol involving a drug or medical device
- Patients unable to follow the protocol, as determined by the investigator
- Patient refusing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
There are various treatments for plantar fasciitis, including physical therapy, orthopedic inserts or steroid infiltrations. However, it is estimated that about 20% of patients do not respond to first-line treatment [Rompe, Sports Med Arthrosc Rev, 2009]. It is therefore necessary to be able to integrate new treatments into the management of this condition. The objective of the study is to assess the effect on pain and the safety of the percutaneous ultrasound-guided tenotomy associated with a platelet rich plasma injection to treat refractory plantar fasciitis.
Read the detailed description
- Pre-inclusion visit (consultation for scheduling the procedure) After verification of the inclusion criteria, the investigating rheumatologist will inform the patient of the study and give him/her the information note. The patient will be offered a period of reflection before signing the consent form. As the procedure requires prior precautions, this will allow the patient to become aware of them. The patient will be given a prescription for a walking boot and a pair of walking sticks.
- Inclusion visit (D0)
After verification of all the inclusion and non-inclusion criteria, the following examinations will be performed during the inclusion visit before the procedure:
- Signature of the consent by the patient and the investigator
- Interrogatory including collection of concomitant treatments, evaluation of the walking perimeter, evaluation of sports activities
- Clinical examination of the foot (Heel tenderness index)
- Standard X-ray of the foot (if not performed at screening)
- Plantar ultrasound = echogenicity of the plantar aponeurosis, measurement of thickness in mm, search for hypervascularization by Doppler
- VAS pain during activity
- FAAM self-questionnaire
- Procedure in 3 steps:
- Local anesthesia by tibial block 60 minutes before the tenotomy
- Venous sampling of 10 ml and centrifugation for 5 minutes
- Needle tenotomy and injection of 1 ml of PRP at the end of the procedure
- Prescription of enoxaparin at a preventive dose for 7 days
The tolerance of the procedure will be evaluated immediately after the procedure, using a VAS for pain. This will be collected by a nurse. We will also collect the acceptability of the procedure as well as the immediate complications (vagal discomfort, bleeding at the injection site).
The patient will then be monitored for two hours (4 times) in order to verify the lifting of the sensory block and the pain during it.
At the end of the consultation, the patient will receive a patient logbook to be completed at home in the 7 days following the procedure and at 14 days (collection of pain at the injection site and possible side effects) and a second logbook to be completed 6 weeks after the procedure.
-First protocol follow-up at home: D7 The patient will have filled out a daily pain VAS and notified any side effects related to the procedure and the analgesic intake during the first week.
A telephone contact will be made at this date by an investigating physician, or a mandated person, in order to ensure that the logbook has been filled out correctly and that there are no complications. The call will also remind the patient to return the questionnaire by mail (stamped and addressed envelope provided).
- Second protocol follow-up at home: S6 +/- 3 days
Six weeks after the procedure, the patient will complete the patient booklet given at D0 at home:
- FAAM self-questionnaire
- VAS pain during activity
- Occurrence of complications
- Gait perimeter
- Third protocol follow-up: consultation at M3 +/- 7 days A follow-up consultation is performed 3 months after the procedure. This corresponds to the usual follow-up of the patient.
During the consultation, the following examinations will be performed
- Clinical examination (HTI)
- Ultrasound of the foot
- VAS pain during activity
- Complications
- FAAM self-questionnaire
- Gait perimeter
- Questions about returning to sport
- Fourth protocol follow-up: consultation at M6 +/- 7 days (main objective) During the consultation, the following examinations will be performed
- Clinical examination (HTI)
- Ultrasound of the foot
- VAS pain during activity
- Complications
- FAAM self-questionnaire
- Gait perimeter
- Questions about returning to sport
- Conditions
- Plantar Fascitis
- Being tested
- Percutaneous tenotomy + PRP
- Keywords
- Plantar fasciitis, needle tenotomy, ultrasound, platelet rich plasma
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous tenotomy + PRPProcedure or surgery
The patients will receive a percutaneous ultrasound-guided treatment including a needle tenotomy followed by a PRP injection in the plantar fasciitis.
| Study group | Role | What they receive |
|---|---|---|
| percutaneous tenotomy + PRP | Experimental | There will be a single arm receiving the treatment being evaluated Receives: Procedure: Percutaneous tenotomy + PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the evolution of plantar pain after treatment combining needle tenotomy and PRP injection in refractory plantar fasciitis.
VAS pain at activity
Measured: 6 months
Secondary outcomes (6)
Evaluate the tolerance of the procedure
To evaluate the tolerance of the procedure, a VAS [0 to 10] will be filled in by the patient to evaluate the pain felt during the procedure.
Measured: 6 weeks, 3 months, 6 months
Evaluate the acceptability of the procedure
To assess the acceptability of the procedure, the following question will be asked: Would you be willing to repeat this procedure if necessary?
Measured: 6 weeks, 3 months, 6 months
Evaluate the evolution of the functional discomfort
To evaluate the effect on function, we will use two parameters: the FAAM self-questionnaire and the walking perimeter. The FAAM (Foot and Ankle Ability Measure) self-questionnaire will be completed by the patient before the procedure and then 6 weeks, 3 months and 6 months after the procedure. The score is composed of 21 items evaluating the discomfort in daily activities and 8 in sports activities. The walking perimeter (distance the patient can walk without stopping) will be evaluated at 6 weeks, 3 months and 6 months. It will be assessed by the following scale: Unlimited / More than 1 Km / From 500 to 1000m / From 100 to 500m / Less than 100m / Walking impossible.
Measured: 6 weeks, 3 months, 6 months
Evaluate the return to sports activities
To evaluate the return to sport, the following 3 questions will be asked to the patient: Have you resumed your sport activity? If yes, how long after the infiltration? Was it possible to resume the activity at the same level as before? This will be collected at 3 and 6 months.
Measured: 6 weeks, 3 months, 6 months
Evaluate the evolution of pain when pressing the insertion of the plantar fascia
The HTI (physician-assessed Heel Tenderness Index) score will be assessed before the procedure and after 3 and 6 months. It is a score ranging from 0 to 3 (0 = no pain; 1 = pain; 2 = pain and grimace; 3 = pain, grimace, and foot removal).
Measured: 6 weeks, 3 months, 6 months
Evaluate the evolution of the ultrasound data
Two items will be evaluated before the procedure and after 3 and 6 months:
- Thickness of the superficial plantar fascia at the insertion
- Doppler hypervascularization
Measured: 6 weeks, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start9 Jan 2023
- Primary completion11 Aug 2025
- Study completion11 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Model description
- The VAS pain data will be compared between before the procedure and 6 months after using a Wilcoxon ranks test for paired data.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Regen Lab SA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622279
- Sponsor's protocol ID
- RC22_0153
- Acronym
- ANTILOPE
- Status last verified
- Sep 2025
- First submitted
- 13 Nov 2022
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Needle Tenotomy Associated With Platelet-rich Plasma Injection Platelet-rich Plasma in the Treatment of Refractory Plantar Fasciitis: a Pilot Study of the Effect on Pain and Tolerance
- ClinicalTrials.gov ID
- NCT05622279
- Acronym / sponsor ID
- ANTILOPE / RC22_0153
- Conditions
- Plantar Fascitis
- Keywords
- Plantar fasciitis, needle tenotomy, ultrasound, platelet rich plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Regen Lab SA
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 11 Aug 2025 (actual)
- Study completion
- 11 Aug 2025 (actual)
- First posted
- 18 Nov 2022 (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.
There are various treatments for plantar fasciitis, including physical therapy, orthopedic inserts or steroid infiltrations. However, it is estimated that about 20% of patients do not respond to first-line treatment [Rompe, Sports Med Arthrosc Rev, 2009]. It is therefore necessary to be able to integrate new treatments into the management of this condition. The objective of the study is to assess the effect on pain and the safety of the percutaneous ultrasound-guided tenotomy associated with a platelet rich plasma injection to treat refractory plantar fasciitis.
Detailed description
- Pre-inclusion visit (consultation for scheduling the procedure) After verification of the inclusion criteria, the investigating rheumatologist will inform the patient of the study and give him/her the information note. The patient will be offered a period of reflection before signing the consent form. As the procedure requires prior precautions, this will allow the patient to become aware of them. The patient will be given a prescription for a walking boot and a pair of walking sticks.
- Inclusion visit (D0)
After verification of all the inclusion and non-inclusion criteria, the following examinations will be performed during the inclusion visit before the procedure:
- Signature of the consent by the patient and the investigator
- Interrogatory including collection of concomitant treatments, evaluation of the walking perimeter, evaluation of sports activities
- Clinical examination of the foot (Heel tenderness index)
- Standard X-ray of the foot (if not performed at screening)
- Plantar ultrasound = echogenicity of the plantar aponeurosis, measurement of thickness in mm, search for hypervascularization by Doppler
- VAS pain during activity
- FAAM self-questionnaire
- Procedure in 3 steps:
- Local anesthesia by tibial block 60 minutes before the tenotomy
- Venous sampling of 10 ml and centrifugation for 5 minutes
- Needle tenotomy and injection of 1 ml of PRP at the end of the procedure
- Prescription of enoxaparin at a preventive dose for 7 days
The tolerance of the procedure will be evaluated immediately after the procedure, using a VAS for pain. This will be collected by a nurse. We will also collect the acceptability of the procedure as well as the immediate complications (vagal discomfort, bleeding at the injection site).
The patient will then be monitored for two hours (4 times) in order to verify the lifting of the sensory block and the pain during it.
At the end of the consultation, the patient will receive a patient logbook to be completed at home in the 7 days following the procedure and at 14 days (collection of pain at the injection site and possible side effects) and a second logbook to be completed 6 weeks after the procedure.
-First protocol follow-up at home: D7 The patient will have filled out a daily pain VAS and notified any side effects related to the procedure and the analgesic intake during the first week.
A telephone contact will be made at this date by an investigating physician, or a mandated person, in order to ensure that the logbook has been filled out correctly and that there are no complications. The call will also remind the patient to return the questionnaire by mail (stamped and addressed envelope provided).
- Second protocol follow-up at home: S6 +/- 3 days
Six weeks after the procedure, the patient will complete the patient booklet given at D0 at home:
- FAAM self-questionnaire
- VAS pain during activity
- Occurrence of complications
- Gait perimeter
- Third protocol follow-up: consultation at M3 +/- 7 days A follow-up consultation is performed 3 months after the procedure. This corresponds to the usual follow-up of the patient.
During the consultation, the following examinations will be performed
- Clinical examination (HTI)
- Ultrasound of the foot
- VAS pain during activity
- Complications
- FAAM self-questionnaire
- Gait perimeter
- Questions about returning to sport
- Fourth protocol follow-up: consultation at M6 +/- 7 days (main objective) During the consultation, the following examinations will be performed
- Clinical examination (HTI)
- Ultrasound of the foot
- VAS pain during activity
- Complications
- FAAM self-questionnaire
- Gait perimeter
- Questions about returning to sport
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The VAS pain data will be compared between before the procedure and 6 months after using a Wilcoxon ranks test for paired data.
| Arm | Type | Receives |
|---|---|---|
| percutaneous tenotomy + PRP | Experimental | Procedure: Percutaneous tenotomy + PRPThere will be a single arm receiving the treatment being evaluated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with chronic inferior heel pain diagnosed as plantar fasciitis plantar fasciitis evolving for more than 3 months with a pain VAS at activity ≥ 4/10
- Failure of the initial management including physical therapy, adaptation of footwear and local steroid infiltration
- Patient 18 years of age or older
- Patient affiliated to a social security plan
- Patient able to understand the protocol and having signed an informed informed consent
Key exclusion criteria (14 listed)
- Patients on NSAIDs and refusing to discontinue them 1 week and 1 week after the procedure
- Corticosteroid infusion at the same lesion site in the last 3 months
- History of PRP injection at the same lesion site
- Treatment with antiplatelet agents [Acetylsalicylic acid (Aspegic, Kardegic, Duoplavin, Resitune, Asasantine), Clopidogrel (Plavix, Duoplavin), Dipyridamole (Persantine, Cleridium, Asasantine)]
- Coagulation disorders: thrombocytopenia < 150,000 platelets/mm3 - Patients on curative anticoagulants
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 |
|---|---|---|
| Percutaneous tenotomy + PRPThe patients will receive a percutaneous ultrasound-guided treatment including a needle tenotomy followed by a PRP injection in the plantar fasciitis. | Procedure or surgery | percutaneous tenotomy + PRP |
Primary outcome
To evaluate the evolution of plantar pain after treatment combining needle tenotomy and PRP injection in refractory plantar fasciitis.
Time frame: 6 months
VAS pain at activity
6 secondary outcomes
Evaluate the tolerance of the procedure
Time frame: 6 weeks, 3 months, 6 months
Evaluate the acceptability of the procedure
Time frame: 6 weeks, 3 months, 6 months
Evaluate the evolution of the functional discomfort
Time frame: 6 weeks, 3 months, 6 months
Evaluate the return to sports activities
Time frame: 6 weeks, 3 months, 6 months
Evaluate the evolution of pain when pressing the insertion of the plantar fascia
Time frame: 6 weeks, 3 months, 6 months
Evaluate the evolution of the ultrasound data
Time frame: 6 weeks, 3 months, 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 16 Sep 2025.
- 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 Percutaneous tenotomy + PRP in people with Plantar Fascitis, run by Nantes University Hospital 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 5 inclusion and 14 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 Sep 2025. 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?
To evaluate the evolution of plantar pain after treatment combining needle tenotomy and PRP injection in refractory plantar fasciitis. (time frame: 6 months). 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 Sep 2025.