- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06696118
Electromagnetic Transduction Therapy on Osteoarthritis in the Foot and Ankle
May 26, 2026 updated by: Elizabeth Bondi, Mayo Clinic
Electromagnetic Transduction Therapy (EMTT) on Mid-foot Osteoarthritis: A Pilot Study
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
• Men and women with osteoarthritis of the foot and/or ankle confirmed via radiographs.
Exclusion Criteria:
• 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mid-foot osteoarthritis
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS) for Pain
Time Frame: Baseline, 3 weeks, 3 months, 6 months
|
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)
Time Frame: Baseline, 3 weeks, 3 months, 6 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elizabeth Bondi, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 13, 2025
Primary Completion (Actual)
March 1, 2026
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
November 18, 2024
First Submitted That Met QC Criteria
November 18, 2024
First Posted (Actual)
November 20, 2024
Study Record Updates
Last Update Posted (Actual)
May 28, 2026
Last Update Submitted That Met QC Criteria
May 26, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-002661
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.