A Test of Efficacy and Foot Position Alteration in Patients Wearing Good Feet Arch Supports for t… (NCT07103070) | Clinical Trial Compass
CompletedNot Applicable
A Test of Efficacy and Foot Position Alteration in Patients Wearing Good Feet Arch Supports for the Treatment of Pain
United States43 participantsStarted 2022-06-13
Plain-language summary
This study is a single armed prospective case series designed to evaluate the efficacy of treating common structural-related foot ailments (i.e. plantar fasciitis, metatarsalgia, and/or hallux valgus) with a high quality non-custom made arch support. It is believed that these conditions are the result of inadequate or poorly fitted arch supports resulting in a lack of structural correction in the foot while weight bearing. Over-the-counter insoles are believed to counteract the shortcomings in foot structure that result in these painful conditions. In this study, it is proposed that changes in foot morphology can be measured quantitatively using weight bearing CT Scan (Computerized Tomography) and X-rays of the subject with and without the arch supports. Subjects will also answer questions from a validated series of questionnaires pertaining to their foot condition and generalized health and activity level.
The study is a minimal risk study, with all subjects receiving the arch supports being investigated. There is no placebo offered. Initial evaluation of all subjects will include all imaging and measurements. Collection of subjective responses will occur after 4 weeks, 8 weeks, and 12 weeks of treatment.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men or women ≥ 18 and ≤ 65 years of age
* Able and willing to comply with study procedures, and a signed and dated
* Diagnosed with symptomatic hallux valgus and/or plantar fasciitis and/or metatarsalgia
* Has had foot pain for at least 30 days
* Willing and able to utilize insole when walking for 90 days
* BMI ≤ 35
* Able to walk up to 0.5 miles without difficulty in a 24-hour period
Exclusion Criteria:
* Inability or unwillingness to comply with study procedures
* Gross asymmetry in feet, where shoe size differs by 2 or more full sizes between right and left foot
* Subject has had a CT performed within the last 30 days, for any body part.
* Prior partial or total amputation of a foot
* BMI \> 35.
* Unilateral or bilateral foot deformity that would hinder the fitting of an over-the-counter arch support, such as active Charcot foot or Charcot with boney prominence
* Ulcers or open sores on either foot
* Currently wearing custom shoes or insoles.
* Currently ambulating with a cane, crutches, walker.
* Currently using any type of foot or ankle brace, and/or having used a brace in the last 30 days.
* Pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient Reported Outcome Measurement Information System (PROMIS)-Pain Intensity Score
Timeframe: 12 weeks
2
Patient Reported Outcome Measurement Information System (PROMIS)-Pain Interference Score