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

Exclusion Criteria12

• Impaired skin integrity in the location(s) to be treated.
• Current wounds or ulcerations.
• Diagnosis of active bleeding tendencies, hemorrhage, or thrombosis.
• + 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.