Shortwave Diathermy In-home Treatment for Indianapolis VA-only Patients Diagnosed With Peripheral Artery Disease and Peripheral Neuropathy

This is a single-site, non-randomized, open label, exploratory clinical trial to evaluate the effects of the Replexa+ shortwave diathermy treatment in patients diagnosed with peripheral artery disease (PAD) and peripheral neuropathy. This pilot study will examine changes in lower extremity perfusion in a total of ten (10) Veteran patients at the Roudebush VA Medical Center in Indianapolis, Indiana, USA.

The proposed research will study the effects of the Replexa+ device, a Class II, non-invasive device that is cleared to market by the FDA (510k# K162240) and available to prescribing physicians at Veterans Affairs (VA) medical facilities. The Replexa+ device generates a form of electromagnetic energy (shortwave diathermy) to provide therapeutic heat to affected areas, deeper than infrared lights and heating pads. This type of therapeutic heat treatment has been widely used in clinical settings. The Replexa+ system consists of a generating unit (device) connected by a cable to a treatment applicator that is placed against the treated areas over normal clothing. The device operates at 27.12 megahertz (MHz), providing deep heating therapeutic effects to the body tissues.

Patients enrolled in this study will follow the manufacturer's instructions for use of the Replexa+ device and treatment. Treatment will comprise of two 30-minute sessions per day, approximately 8-12 hours apart, for 3 months, at prescribing physician-specified locations of the body.

At the post-treatment visit, the study doctor will assess the success or failure of treatment by comparing baseline measurement testing to post-treatment testing. Treatment failure will be defined as any measurable decrease in limb perfusion as evidenced by lower extremity arterial doppler testing.

Inclusion criteria

• 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 criteria

• 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.