Shortwave Diathermy In-home Treatment for Indianapolis VA-only Patients Diagnosed With Peripheral Artery Disease and Peripheral Neuropathy
Starting soon · Not applicable
Conditions studied: Peripheral Arterial Disease, Peripheral Neuropathy
In brief
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.
Key facts
- Study ID
- NCT07336381
- Run by
- Indiana University
- People needed
- 10
- Starts
- 2026-07-01
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-05-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of peripheral artery disease (PAD).
- Participants must exhibit PAD severity, defined by the following manifestation and corresponding Rutherford classifications:
- Claudication of the index limb (Rutherford Category 2 or 3- documented as pain with walking) in conjunction with one or more of the following:
- ankle brachial index (ABI) greater than or equal to 0.6 mmHg, as measured no more than 6 months prior to screening
- resting toe brachial index (TBI) greater than or equal to 0.4, as measured no more than 6 months prior to screening
- Note: In cases where ankle and toe systolic pressures are unavailable due to calcification and/or toe amputation, collection of angiographic data is acceptable to determine locations of blockages or reduced perfusion.
- Diagnosis of peripheral neuropathy, as evidenced by review of medical records.
- Competent to give consent.
- Age 18 years or older.
You may not qualify if…
- Impaired skin integrity in the location(s) to be treated.
- Current wounds or ulcerations.
- 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.
- History of skeletal tuberculosis.
- Patients, in the investigator's opinion, whose index limb condition is rapidly deteriorating and may require major amputation within 30 days of screening.
- Conditions that impair cognitive function.
- Severe concomitant disease(s), or any additional condition(s) which the investigator feels constitute(s) criteria for exclusion of a particular subject.
Where it is running
- Richard L. Roudebush Veterans Affairs Medical Center — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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