Shortwave Diathermy In-home Treatment for Indianapolis VA-only Patients Diagnosed With Peripheral… (NCT07336381) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Shortwave Diathermy In-home Treatment for Indianapolis VA-only Patients Diagnosed With Peripheral Artery Disease and Peripheral Neuropathy
United States10 participantsStarted 2026-07-01
Plain-language summary
This research project is designed to see if treatment with the Replexa+ shortwave diathermy device daily for 3 months will improve blood flow in the lower legs and feet of patients diagnosed with peripheral artery disease and peripheral neuropathy.
Who can participate
Age range
18 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
. Diagnosis of peripheral artery disease (PAD).
. Participants must exhibit PAD severity, defined by the following manifestation and corresponding Rutherford classifications:
. Diagnosis of peripheral neuropathy, as evidenced by review of medical records.
. Competent to give consent.
. Age 18 years or older.
Exclusion criteria
. Impaired skin integrity in the location(s) to be treated.
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
Compare baseline and post-treatment lower extremity arterial dopplers to determine change in lower extremity arterial perfusion.
. Diagnosis of active bleeding tendencies, hemorrhage, or thrombosis.
. 2+ pitting edema in either lower extremity.
. Active infection defined as elevated white blood cell count \>11,500/µL or fever \>101.5 degrees Fahrenheit or currently taking antibiotic medication(s) for an active infection.
. Existence of metal hardware in the area(s) to be treated: Any patient with implanted electronic or metal device such as a pacemaker, bladder stimulator, spinal cord stimulator or electrodes for a myoelectric prosthesis, IUD, surgical staples or implanted metallic leads.
. Pregnant individuals.
. Presence of renal disease (creatinine \> 2.5 mg/dl and estimated glomerular filtration rate (eGFR) \<30 mL/min) or patients on chronic hemodialysis.