Recruiting

Observational Study

Sponsor:

University of Florida

Code:

NCT05075005

Conditions

Plantar Fasciitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Treatment Cohort

Control Cohort

Study Details

Brief summary:

Modern footwear has been implicated as a contributor to foot pathology and changes in the biomechanics of gait. In addition to footwear, the investigators propose that the lack of terrain variation may directly contribute to the development of common foot pathologies, resulting from decreased intrinsic foot muscle function. This study will examine the current understanding of terrain variation on foot musculature strength and its possible correlation with structural and functional changes within the foot.

Conditions

Plantar Fasciitis

Study ID

NCT05075005

Start date

Jul 15, 2022

Status verified date

Sep, 2026

Completion date

Jan 20, 2027

Anticipated

Primary completion date

Jan 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria for Group A:

  • Patients presenting to the University of Florida Orthopaedics and Sports Medicine Institute with pain on the plantar medial or central heel for greater than 60 days with the following features
  • Pain upon palpation, or insidious pain onset
  • Pain accentuated after long periods of weight bearing activities or after periods of rest
  • A reduction in pain following light activities (McPoil et al., 2008)
  • Failure to respond to treatment modalities for 6 months, including plantar fascia and muscle stretching, nonsteroidal anti-inflammatory medication, supportive insoles, and night splints
  • Age >18 years

Inclusion Criteria for Group B:

  • Healthy individuals in the general population of Gainesville and surrounding areas
  • Age >18

Exclusion Criteria for Group A:

  • History of lower leg or foot surgery, hindfoot trauma or fracture of the affected limb within the previous year.
  • Diagnosis of diabetic neuropathy, fibromyalgia, neurological disease, Achilles tendinopathy, metatarsalgia, tarsal tunnel syndrome or heel pad syndrome
  • Body Mass Index (BMI) > 35
  • Currently taking or applying any anti-inflammatory medication or medication to control nerve pathology, prescription or over the counter
  • Third trimester pregnancy

Exclusion Criteria for Group B:

  • Any foot or lower limb pathology resulting in discomfort or gait limitation
  • Diagnosis of diabetic neuropathy, fibromyalgia, neurological disease
  • BMI >35
  • Currently taking or applying any anti-inflammatory medication or medication to control nerve pathology, prescription or over the counter
  • Third trimester pregnancy

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Treatment Cohort

Treatment Cohort: Will utilize a minimalist shoe (Vibram® Fivefingers) and follow the training protocol described below for training on natural terrain.

experimental: Control Cohort

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.

Interventions

Treatment Cohort

Subjects will walk on a specified University of Florida Natural Area Teaching Laboratory's (NATL) nature trail for approximately 30 minutes, three times per week for 8 weeks while wearing the minimalist shoes provided by the study team. Time, distance, and GPS walking route will be recorded utilizing the MapMyRun smartphone application, which is free to download and easy to use. The study team will assist each subject with downloading the application onto their smartphone and provide a brief training on app use at their pre-trial visit. Subjects will be asked to save each training session within the app to report to the study team upon completion of the 8-week training protocol. Subjects will be instructed to walk at a comfortable pace and to stop if they begin experiencing increased pain or discomfort.

Control Cohort

Subjects will walk on hardscapes (e.g. sidewalk, asphalt, track, etc) for approximately 30 minutes, three times per week for 8 weeks while wearing the minimalist shoes provided by the study team. Similarly to the treatment group, subjects will be asked to utilize the MapMyRun smartphone application to record their training sessions. Subjects will be instructed to walk at a comfortable pace and to stop if they begin experiencing increased pain or discomfort.

Primary outcome measure

  • Revised Foot Function Index (FFI-R) [ Time Frame: Up to 9 weeks ]
  • Visual Analog Scale (VAS) [ Time Frame: Up to 9 weeks ]

Central Contacts and Locations

Central contacts

Antony Merendino, DPM

352-273-7198merena@ortho.ufl.edu

Shea Herlihy, MS

352-273-7361herliso@ortho.ufl.edu

Locations

UF Health Orthopaedics and Sports Medicine Institute

Recruiting

Gainesville, Florida, United States, 32611

Contacts

Aimee M Struk, MEd

352-273-7419strukam@ortho.ufl.edu

MaryBeth Horodyski, Ed.D.

352-273-7074horomb@ortho.ufl.edu

More Information

Sponsor

University of Florida

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-09-08.