NCT07336381

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Peripheral Arterial Disease
• Peripheral Neuropathy

Interventions

Type	Name	Description
DEVICE	Replexa shortwave diathermy	Treatment with home use of the Replexa+ shortwave diathermy device twice daily for 3 months.

Timeline

• Start date: 2025-12-05
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-01-13
• Last updated: 2026-01-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study