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

Inclusion Criteria:

1. Diagnosis of peripheral artery disease (PAD).

2. Participants must exhibit PAD severity, defined by the following manifestation andcorresponding Rutherford classifications: Claudication of the index limb (Rutherford Category 2 or 3- documented as pain withwalking) in conjunction with one or more of the following:

• ankle brachial index (ABI) greater than or equal to 0.6 mmHg, as measured nomore than 6 months prior to screening

• resting toe brachial index (TBI) greater than or equal to 0.4, as measured nomore than 6 months prior to screening Note: In cases where ankle and toe systolic pressures are unavailable due tocalcification and/or toe amputation, collection of angiographic data is acceptableto determine locations of blockages or reduced perfusion.

3. Diagnosis of peripheral neuropathy, as evidenced by review of medical records.

4. Competent to give consent.

5. Age 18 years or older.

Exclusion Criteria:

1. Impaired skin integrity in the location(s) to be treated.

2. Current wounds or ulcerations.

3. Diagnosis of active bleeding tendencies, hemorrhage, or thrombosis.

4. 2+ pitting edema in either lower extremity.

5. 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 activeinfection.

6. Existence of metal hardware in the area(s) to be treated: Any patient with implantedelectronic or metal device such as a pacemaker, bladder stimulator, spinal cordstimulator or electrodes for a myoelectric prosthesis, IUD, surgical staples orimplanted metallic leads.

7. Pregnant individuals.

8. Presence of renal disease (creatinine > 2.5 mg/dl and estimated glomerularfiltration rate (eGFR) <30 mL/min) or patients on chronic hemodialysis.

9. History of skeletal tuberculosis.

10. Patients, in the investigator's opinion, whose index limb condition is rapidlydeteriorating and may require major amputation within 30 days of screening.

11. Conditions that impair cognitive function.

12. Severe concomitant disease(s), or any additional condition(s) which the investigatorfeels constitute(s) criteria for exclusion of a particular subject.