Plantar Fasciitis of Both FeetINFILTRA-PLANTNCT06671223
Effectiveness of Infiltrations in the Treatment of Plantar Fasciopathy
A study testing Infiltration and Conservative treatment in people with Plantar Fasciitis of Both Feet and Plantar Fasciopathy, run by University of Seville at 1 site in Spain.
Trial summary
This clinical study aims to evaluate the effectiveness of infiltrations in the treatment of plantar fasciopathy, a painful condition that affects the sole of the foot and is common in active people. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Plantar Fasciitis of Both Feet, Plantar Fasciopathy
- What is being tested?
- Infiltration and Conservative treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2025to 1 Dec 2026
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: Participants aged 18 to 50 years. Diagnosis: Confirmed diagnosis of plantar fasciopathy based on clinical evaluation and imaging (if applicable).
- Duration of Symptoms: Symptoms persisting for at least 6 weeks prior to enrollment.
- Pain Level: Reported pain level of at least 4 on the Visual Analog Scale (VAS) at baseline.
- Ability to Comply: Participants must be able to follow study protocols and attend follow-up appointments.
- Informed Consent: Participants must provide written informed consent to participate in the study.
Who cannot join
- Other Foot Pathologies: Presence of other significant foot conditions (e.g., fractures, arthritis, tarsal tunnel syndrome) that could interfere with the study results.
- Pregnancy or Breastfeeding: Pregnant or breastfeeding individuals will be excluded from the study.
- Neurological Disorders: History of significant neurological disorders affecting lower limb function.
- Systemic Conditions: Patients with systemic conditions (e.g., diabetes, autoimmune diseases) that could affect healing or response to treatment.
- Allergy to Corticosteroids: Known allergy or adverse reaction to corticosteroids or local anesthetics.
- Psychiatric Disorders: Individuals with severe psychiatric disorders that may impair their ability to provide informed consent or adhere to the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
ANA MARIA RP DRA. ANA MARIA RAYO PEREZ, PRINCIPAL INVESTIGATOR contact
RAQUEL GDP DRA. RAQUEL GARCIA DE LA PEÑA, PhD in Podiatry Science contact
Spain1 site
Universidad de Sevilla
Seville, 41009
RAQUEL GDP DRA. RAQUEL GARCIA DE LA PEÑA, PhD in Podiatry Science, raquelgp@us.es
About this study
Official title: Effectiveness of Infiltrations in the Treatment of Plantar Fasciopathy: A Randomized Clinical Study.
This clinical study aims to evaluate the effectiveness of infiltrations in the treatment of plantar fasciopathy, a painful condition that affects the sole of the foot and is common in active people. Plantar fasciopathy is caused by inflammation or damage to the plantar fascia, the tissue that connects the heel to the toes. Participants in this study will be randomly assigned to receive one of two treatments: corticosteroid infiltrations or conservative treatment without infiltrations. Infiltrations will be guided by ultrasound to ensure accuracy. The study will evaluate pain reduction and improvement in foot function over a six-month period. The objective of the study is to determine if infiltrations provide a significant improvement compared to other non-invasive treatments. The results will help doctors and patients make informed decisions about the best treatment options for plantar fasciopathy.
Read the detailed description
This clinical study, titled \"Effectiveness of Infiltrations in the Treatment of Plantar Fasciopathy\", will be carried out at the University of Seville and its main objective is to evaluate the impact of corticosteroid infiltrations on pain reduction and functional improvement in patients diagnosed with plantar fasciopathy.
- Being tested
- Infiltration, Conservative treatment
- Keywords
- plantar fasciitis, fasciopaty, corticosteroid, PRP, hyaluronic acid, infiltrations, treatment
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfiltrationDrug
Also called Intervention group
The intervention consists of the administration of infiltrations in the affected plantar fascia of participants with a diagnosis of plantar fasciopathy. A drug such as a corticosteroid, PRP or hyaluronic acid will be used, which will be injected under ultrasound guidance to ensure precision at the site of the injury. This intervention aims to reduce inflammation and pain, thus improving the functionality of the foot. Up to three infiltrations will be performed, depending on the patient\'s response to treatment and medical evaluation. The infiltrations will be compared with a control group that will receive conservative treatment without infiltrations, to evaluate the relative effectiveness of this pharmacological intervention in the management of plantar fasciopathy.
Conservative treatmentOther
Also called Control group
The control group is used to compare the effectiveness of infiltrations with a non-invasive approach in the treatment of plantar fasciopathy. This group will not receive any infiltration and will focus on conservative interventions.
| Study group | Role | What they receive |
|---|---|---|
| Corticoesteroid Infiltrations | Experimental | In this group, participants will receive infiltrations directly into the affected plantar fascia. This intervention aims to reduce the inflammation and pain associated with plantar fasciopathy. Receives: Drug: Infiltration |
| Conservative treatment | Placebo comparator | Participants in this group will receive conservative treatment that does not include infiltrations. This approach is based on non-invasive methods that are commonly used to manage plantar fasciopathy. Receives: Other: Conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Level
Pain level will be assessed using the Visual Analogue Scale 0 to 10 points (VAS), where participants will mark their pain level on a 10 cm line, from \"no pain\" (0) to \"unbearable pain\" (10).
Measured: Evaluations will be carried out at the beginning of the study, and at 3, 6 and 12 weeks after the intervention.
Secondary outcomes (1)
Functional Improvement
Foot functionality will be assessed using the Foot Function Index 0 to 100 points (FFI), which measures the functional capacity of the foot and the impact of pain on daily activities.
Measured: Evaluations at the beginning, and at 3, 6 and 12 weeks post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start1 Jun 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar Fasciitis of Both FeetStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomly assigned to one of two groups: Intervention group: They will receive corticosteroid infiltrations under ultrasound guidance. Control group: They will receive conservative treatment that may include physiotherapy and recommendations for foot care, without infiltrations.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANA MARIA RAYO PEREZ, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671223
- Sponsor's protocol ID
- TFMAGM
- Other IDs
- TFMAGM2024
- Acronym
- INFILTRA-PLANT
- Status last verified
- Oct 2024
- First submitted
- 26 Sep 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Infiltrations in the Treatment of Plantar Fasciopathy: A Randomized Clinical Study.
- ClinicalTrials.gov ID
- NCT06671223
- Acronym / sponsor ID
- INFILTRA-PLANT / TFMAGM
- Keywords
- plantar fasciitis, fasciopaty, corticosteroid, PRP, hyaluronic acid, infiltrations, treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 4 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.
This clinical study aims to evaluate the effectiveness of infiltrations in the treatment of plantar fasciopathy, a painful condition that affects the sole of the foot and is common in active people. Plantar fasciopathy is caused by inflammation or damage to the plantar fascia, the tissue that connects the heel to the toes. Participants in this study will be randomly assigned to receive one of two treatments: corticosteroid infiltrations or conservative treatment without infiltrations. Infiltrations will be guided by ultrasound to ensure accuracy. The study will evaluate pain reduction and improvement in foot function over a six-month period. The objective of the study is to determine if infiltrations provide a significant improvement compared to other non-invasive treatments. The results will help doctors and patients make informed decisions about the best treatment options for plantar fasciopathy.
Detailed description
This clinical study, titled \"Effectiveness of Infiltrations in the Treatment of Plantar Fasciopathy\", will be carried out at the University of Seville and its main objective is to evaluate the impact of corticosteroid infiltrations on pain reduction and functional improvement in patients diagnosed with plantar fasciopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two groups: Intervention group: They will receive corticosteroid infiltrations under ultrasound guidance. Control group: They will receive conservative treatment that may include physiotherapy and recommendations for foot care, without infiltrations.
| Arm | Type | Receives |
|---|---|---|
| Corticoesteroid Infiltrations | Experimental | Drug: InfiltrationIn this group, participants will receive infiltrations directly into the affected plantar fascia. This intervention aims to reduce the inflammation and pain associated with plantar fasciopathy. |
| Conservative treatment | Placebo comparator | Other: Conservative treatmentParticipants in this group will receive conservative treatment that does not include infiltrations. This approach is based on non-invasive methods that are commonly used to manage plantar fasciopathy. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: Participants aged 18 to 50 years. Diagnosis: Confirmed diagnosis of plantar fasciopathy based on clinical evaluation and imaging (if applicable).
- Duration of Symptoms: Symptoms persisting for at least 6 weeks prior to enrollment.
- Pain Level: Reported pain level of at least 4 on the Visual Analog Scale (VAS) at baseline.
- Ability to Comply: Participants must be able to follow study protocols and attend follow-up appointments.
- Informed Consent: Participants must provide written informed consent to participate in the study.
Key exclusion criteria (6 listed)
- Other Foot Pathologies: Presence of other significant foot conditions (e.g., fractures, arthritis, tarsal tunnel syndrome) that could interfere with the study results.
- Pregnancy or Breastfeeding: Pregnant or breastfeeding individuals will be excluded from the study.
- Neurological Disorders: History of significant neurological disorders affecting lower limb function.
- Systemic Conditions: Patients with systemic conditions (e.g., diabetes, autoimmune diseases) that could affect healing or response to treatment.
- Allergy to Corticosteroids: Known allergy or adverse reaction to corticosteroids or local anesthetics.
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 |
|---|---|---|
| InfiltrationAlso: Intervention groupThe intervention consists of the administration of infiltrations in the affected plantar fascia of participants with a diagnosis of plantar fasciopathy. A drug such as a corticosteroid, PRP or hyaluronic acid will be used, which will be injected under ultrasound guidance to ensure precision at the site of the injury. This intervention aims to reduce inflammation and pain, thus improving the functionality of the foot. Up to three infiltrations will be performed, depending on the patient\'s response to treatment and medical evaluation. The infiltrations will be compared with a control group that will receive conservative treatment without infiltrations, to evaluate the relative effectiveness of this pharmacological intervention in the management of plantar fasciopathy. | Drug | Corticoesteroid Infiltrations |
| Conservative treatmentAlso: Control groupThe control group is used to compare the effectiveness of infiltrations with a non-invasive approach in the treatment of plantar fasciopathy. This group will not receive any infiltration and will focus on conservative interventions. | Other | Conservative treatment |
Primary outcome
Change in Pain Level
Time frame: Evaluations will be carried out at the beginning of the study, and at 3, 6 and 12 weeks after the intervention.
Pain level will be assessed using the Visual Analogue Scale 0 to 10 points (VAS), where participants will mark their pain level on a 10 cm line, from \"no pain\" (0) to \"unbearable pain\" (10).
1 secondary outcome
Functional Improvement
Time frame: Evaluations at the beginning, and at 3, 6 and 12 weeks post-intervention.
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 4 Nov 2024.
- 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.
ANA MARIA RP DRA. ANA MARIA RAYO PEREZ, PRINCIPAL INVESTIGATOR contact
RAQUEL GDP DRA. RAQUEL GARCIA DE LA PEÑA, PhD in Podiatry Science contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infiltration and Conservative treatment in people with Plantar Fasciitis of Both Feet and Plantar Fasciopathy, run by University of Seville at 1 site in Spain.
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 6 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 4 Nov 2024. 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 Spain. 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. Some participants in this study may receive a placebo. 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 ANA MARIA RP DRA. ANA MARIA RAYO PEREZ, PRINCIPAL INVESTIGATOR (034-955-841-656 ext. +34, anarayo43@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Level (time frame: Evaluations will be carried out at the beginning of the study, and at 3, 6 and 12 weeks after the intervention.). 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 4 Nov 2024.