Electromagnetic Transduction Therapy on Osteoarthritis in the Foot and Ankle

NCT06696118 | Active Not Recruiting FDA Device

• 1 other identifier: 24-002661
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if Electromagnetic Transduction Therapy (EMTT) is a viable treatment option in patients with osteoarthritis of the foot and/or ankle.

Conditions

Osteoarthritis Ankle; Osteoarthritis Foot

Keywords

Electromagnetic Transduction Therapy

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale (VAS) for Pain

  The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain.

  Baseline, 3 weeks, 3 months, 6 months

• Foot and Ankle Ability Measure (FAAM)

  The Foot and Ankle Ability Measure (FAAM) ADL is a 21-item self-report questionnaire measuring Activities of Daily Living. Each item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' to 'unable to do'. Item score totals, which range from 0 to 84 are reported in percentage scores. Higher scores represent higher levels of function, with 100% representing no dysfunction.

  Baseline, 3 weeks, 3 months, 6 months

Study Arms (1)

Mid-foot osteoarthritis

EXPERIMENTAL

Device: Electromagnetic Transduction Therapy (EMTT)

Interventions

Electromagnetic Transduction Therapy (EMTT) DEVICE

Subjects will be treated with Electromagnetic Transduction Therapy (EMTT) using the Curamedix MAGNETOLITH device. Treatments will be administered twice per week, for four weeks. Each treatment will have the following settings: level 8, 8Hz, and 10,000 pulses andwill take about 15 to 20 minutes. Treatments will be spaced 2-3 days apart.

Mid-foot osteoarthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women with osteoarthritis of the foot and/or ankle confirmed via radiographs.

You may not qualify if:

• Pacemaker, active cancer, shrapnel, metal in eye, implantable devices that are not compatible with MRIs, concurrent foot or ankle condition or injury, prior foot or ankle surgery for osteoarthritis, steroid, platelet rich plasma, or hyaluronic acid injection within 2 months of the treatment.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Study Officials

• Elizabeth Bondi

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: March 13, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 13, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)