RecruitingNot ApplicableNCT07336381

Replexa+ Shortwave Diathermy Device for Patients Diagnosed With Peripheral Artery Disease and Peripheral Neuropathy

An Exploratory Clinical Study Using the Replexa+ Device in Veterans With Lower Extremity Peripheral Artery Disease Experiencing Peripheral Neuropathy

Sponsor

Indiana University

Enrollment

10 participants

Start Date

Dec 5, 2025

Study Type

INTERVENTIONAL

Conditions

Peripheral Arterial Disease Peripheral Neuropathy

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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.

Exclusion Criteria12

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.