ClinicalTrials.gg
Not yet recruitingNCT06671223INFILTRA-PLANTUpdated Nov 4, 2024

Effectiveness of Infiltrations in the Treatment of Plantar Fasciopathy

An interventional study of Infiltration and Conservative treatment in Plantar Fasciitis of Both Feet and Plantar Fasciopathy, sponsored by University of Seville. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-11-04.

Sponsored by University of Seville · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 20 studies in Fasciitis, Plantar with a site in Spain — 5 open to participants now, 5 under way, none of them phase 3. Fasciitis, Plantar · Spain.

Planned enrollment
2nd of 19
200 · median 48
Started
2025
the only one that year
No phase
17 of 20
4 open now
Registered
17th of 20
by date
Lead sponsor
5 of 20
University of Seville

Among the 20 studies in Fasciitis, Plantar with a site in Spain, this one is the 2nd largest by planned enrollment of the 19 interventional ones that give a count, is the only one that started in 2025, is one of 17 with no phase, and was the 17th registered.

Fasciitis, Plantar

223 studies on the registry are indexed under Fasciitis, Plantar; 58 are open to participants now.

This study's planned enrollment of 200 is above the median of 56 across 194 interventional studies indexed under Fasciitis, Plantar.

Browse Fasciitis, Plantar studies →

Open to participants now

5 of the 20 studies in Fasciitis, Plantar with a site in Spain are open now, in 1 country. Each count lists the studies.

All 5 open studies →

Where they have run

Who these studies take

Of the 29 Fasciitis, Plantar studies recruiting now, 5 (17%) set no upper age limit and 21 (72%) stop at 75 or younger; 0 take children under 18; 4 take healthy volunteers.

This study: 18 Years to 50 Years · all sexes · no healthy volunteers.

The full table on the hub →
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02

Study 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. 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.

03

Conditions studied

  • Plantar Fasciitis of Both Feet
  • Plantar Fasciopathy

Browse trials for

Keywords

  • plantar fasciitis
  • fasciopaty
  • corticosteroid
  • PRP
  • hyaluronic acid
  • infiltrations
  • treatment
04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

: Participants must provide written informed consent to participate in the study.

Exclusion criteria

Exclusion Criteria:

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, diseases) that could affect healing or response to treatment.

Allergy to : Known allergy or adverse reaction to corticosteroids or local anesthetics.

Psychiatric Disorders: Individuals with severe psychiatric disorders that may impair their ability to provide or adhere to the study protocol.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Corticoesteroid Infiltrations

    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.

    Drug: Infiltration

  • Placebo comparator
    Conservative treatment

    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.

    Other: Conservative treatment

Interventions

  • DrugInfiltration

    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.

    Also known as: Intervention group

  • OtherConservative treatment

    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.

    Also known as: Control group

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 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.

    Time frame: Evaluations at the beginning, and at 3, 6 and 12 weeks post-intervention.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2025; primary completion for Dec 2025, 6 months later.

Of 104 non-industry interventional studies with no phase under Fasciitis, Plantar, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 21. This study's planned 6 months is below that.

Counting every sponsor, half of 109 studies reached it within 11 months; a quarter within 6 and three quarters within 22.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 26, 2024
First posted
Nov 4, 2024
StartEst.
Jun 1, 2025
Primary completionEst.
Dec 1, 2025
CompletionEst.
Dec 1, 2026
Last update
Nov 4, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06671223
Responsible party
ANA MARIA RAYO PEREZ (Principal Investigator, University of Seville) — Principal investigator
First posted
Nov 4, 2024
Start date
Jun 1, 2025 (estimated)
Primary completion
Dec 1, 2025 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Nov 4, 2024

Study contacts

ANA MARIA RP DRA. ANA MARIA RAYO PEREZ, PRINCIPAL INVESTIGATOR
Contact
anarayo43@gmail.com
034-955-841-656 ext. +34
RAQUEL GDP DRA. RAQUEL GARCIA DE LA PEÑA, PhD in Podiatry Science
Contact

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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