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Terrain Variation for Plantar Fasciitis

N/A
Recruiting
Led By Antony Merendino, DPM
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pain accentuated after long periods of weight bearing activities or after periods of rest
Failure to respond to treatment modalities for 6 months, including plantar fascia and muscle stretching, nonsteroidal anti-inflammatory medication, supportive insoles, and night splints
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 9 weeks
Awards & highlights

Study Summary

This triallooks into how changing terrain can affect foot muscles and how that might affect foot pathologies.

Who is the study for?
This trial is for adults over 18 in Gainesville who either have healthy feet or suffer from plantar fasciitis, experiencing heel pain that hasn't improved with standard treatments like stretching, medication, and supportive insoles for at least 6 months.Check my eligibility
What is being tested?
The study investigates how walking on different terrains affects foot muscle strength. It will compare the foot musculature of healthy individuals against those with plantar fasciitis to see if terrain variation influences foot structure and function.See study design
What are the potential side effects?
Since this trial involves non-invasive observation of walking patterns on varied terrains, there are minimal expected side effects. Participants may experience discomfort related to their existing condition during the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My pain worsens with activity or after resting.
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My foot condition hasn't improved after 6 months of standard treatments.
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My pain decreases after doing light activities.
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I am older than 18 years.
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I experience pain when touched or have had a gradual onset of pain.
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I am older than 18 years.
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I have had heel pain for more than 60 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 9 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 9 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Revised Foot Function Index (FFI-R)
Visual Analog Scale (VAS)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Control CohortExperimental Treatment2 Interventions
Control Cohort: Will utilize the same minimalist shoe and follow the same training schedule as the treatment group, with the modification of training on hardscapes.
Group II: Treatment CohortActive Control2 Interventions
Treatment Cohort: Will utilize a minimalist shoe (Vibram® Fivefingers) and follow the training protocol described below for training on natural terrain.

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,338 Previous Clinical Trials
715,256 Total Patients Enrolled
Antony Merendino, DPMPrincipal InvestigatorUniversity of Florida

Media Library

Control Cohort Clinical Trial Eligibility Overview. Trial Name: NCT05075005 — N/A
Plantar Fibroma Research Study Groups: Treatment Cohort, Control Cohort
Plantar Fibroma Clinical Trial 2023: Control Cohort Highlights & Side Effects. Trial Name: NCT05075005 — N/A
Control Cohort 2023 Treatment Timeline for Medical Study. Trial Name: NCT05075005 — N/A
Plantar Fibroma Patient Testimony for trial: Trial Name: NCT05075005 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it still possible to join this research initiative?

"Yes, per the information presented on clinicaltrials.gov this trial is currently enrolling participants. Initially posted in July 15th 2022 and updated most recently in November 2nd 2022, it seeks 60 patients from a single site."

Answered by AI

Does this research study include participants who are 60 years and older?

"The terms of eligibility for this medical study necessitate that candidates be between the ages 18 and 100. Also, there are one trial recruiting patients under eighteen years old and 24 studies enrolling seniors above 65."

Answered by AI

How many participants are the maximum allowed to join this research effort?

"Affirmative. Documentation on clinicaltrials.gov indicates that this medical research effort, which began recruiting participants on July 15th 2022, is still actively seeking volunteers. The team behind the trial are looking for 60 individuals to participate at a single location."

Answered by AI

Am I eligible to participate in this clinical research program?

"To be admitted to this clinical trial, individuals must suffer from plantar fascial fibromatosis and fit within the age range of 18-100. About 60 patients are required for the study."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Hoping for relief from planter fibroma. I'm hoping to prevent or reduce progression of a plantar fibroma.
PatientReceived 1 prior treatment
~25 spots leftby Jul 2025