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A Test of Efficacy and Foot Position Alteration in Patients Wearing Good Feet Arch Supports for the Treatment of Pain

NCT07103070 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2025-08-08

No results posted yet for this study

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.

Conditions

  • Plantar Fasciitis of Both Feet
  • Metatarsalgia
  • Morton Neuroma
  • Hallux Valgus Deformity
  • Low Back Pain
  • Knee Pain
  • Ankle Pain

Interventions

DEVICE

Arch supports

Set of 3 arch supports supplied by Good Feet

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Adam S Landsman, DPM, PhD · Massachusetts General Hospital

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-13
Primary Completion
2023-12-31
Completion
2024-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07103070 on ClinicalTrials.gov