Suspended

fascitisIncobotulinum Toxin vs Corticosteroid for Plantar Fasciitis

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What is being tested

Incobotulinum Toxin A

+ Glucocorticoid

Drug
Who is being recruted

Fasciitis+5

+ Foot Diseases

+ Musculoskeletal Diseases

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: September 2024
See protocol details

Summary

Principal SponsorInstituto Mexicano del Seguro Social
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2024

Actual date on which the first participant was enrolled.

This study aims to find out how two different treatments affect people with plantar fasciitis, a condition that causes heel pain. Researchers are comparing incobotulinum toxin, a type of botulinum toxin, with corticosteroids to see which one helps better with pain relief, improves how the ankle and foot work, and makes daily activities easier for those affected. This is important because finding the best treatment could help people suffering from this painful condition improve their quality of life. Participants in the study will receive either incobotulinum toxin or corticosteroid directly into the affected area of the foot. The study will then monitor changes in pain levels, how well the foot and ankle function, and the ease of performing daily tasks. By comparing these results between the two treatments, the study hopes to identify which one provides more effective relief and improvement in the lives of people with plantar fasciitis.

Official TitleClinical Effects of the Intralesional Application of Incobotulinum Toxin vs Corticosteroid in Patients With Plantar Fascitis
NCT06788158
Principal SponsorInstituto Mexicano del Seguro Social
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

FasciitisFoot DiseasesMusculoskeletal DiseasesNeurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsFasciitis, Plantar

Criteria

5 inclusion criteria required to participate
Age over 18 years.
Any sex.
Diagnosis of plantar fasciitis (pain in the medial plantar calcaneal tubercle which gives rise to the site of plantar fascial insertion into the heel bone and/or pain along the path of its three bands) made by a physician specializing in Physical Medicine and Rehabilitation.
Voluntary acceptance of participation in the study.
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8 exclusion criteria prevent from participating
Diagnosis of ankylosing spondylitis.
Pregnant women.
Previous infiltration treatment with any medication or substance applied to the plantar fascia or gastrocnemius muscles in the last six months.
Anticoagulant treatment.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
will be administered 2 ampoules (200 IU) of Incobotulinum toxin , injectable solution presentation 100 IU ampoule with powder diluted in 1 ml of 0.9% saline solution in a single application at 4 points, in addition to a therapeutic exercise program in the teaching service to later do it at home that will be done daily for 4 months (cryotherapy for 15 minutes on the plantar fascia, active mobilizations of the ankle and foot for 5 minutes, stretching exercises for the triceps surae and plantar fascia for 20 seconds, 3 repetitions, strengthening of intrinsic muscles of the foot).

Group II

Active Comparator
2 ml of dexamethasone will be administered in an 8 mg/2 ml ampoule diluted in 2 ml of lidocaine injectable solution in a 50 ml bottle (20 mg/ml) in a single application at 1 point, in addition to a therapeutic exercise program in the teaching service to later do it at home that will be done daily for 4 months (cryotherapy for 15 minutes on the plantar fascia, active mobilizations of the ankle and foot for 5 minutes, stretching exercises for the triceps surae and plantar fascia for 20 seconds, 3 repetitions, strengthening of intrinsic muscles of the foot).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Hospital General Regional No.1 "Lic. Ignacio García Téllez" IMSS, Calle 41 101, Fénix, 97155 Mérida, Yuc.

Mérida, MexicoOpen Hospital General Regional No.1 "Lic. Ignacio García Téllez" IMSS, Calle 41 101, Fénix, 97155 Mérida, Yuc. in Google Maps
SuspendedOne Study Center