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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Arterial Disease; Peripheral Neuropathy
• Intervention / Treatment: Device: Replexa shortwave diathermy

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristen Evans, RN, CCRC; Phone Number: 317-988-9548; Email: kristen.evans1@va.gov

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Richard L. Roudebush Veterans Affairs Medical Center
      • Contact: Kristen Evans, RN, CCRC; Phone Number: 317-988-9548; Email: kristen.evans1@va.gov
      • Principal Investigator: Michael P. Murphy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosis of peripheral artery disease (PAD).

2. 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.

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 active infection.
6. 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.
7. Pregnant individuals.
8. Presence of renal disease (creatinine > 2.5 mg/dl and estimated glomerular filtration 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 rapidly deteriorating 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 investigator feels constitute(s) criteria for exclusion of a particular subject.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; In-home shortwave diathermy treatment.	Device: Replexa shortwave diathermy; Treatment with home use of the Replexa+ shortwave diathermy device twice daily for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare baseline and post-treatment lower extremity arterial dopplers to determine change in lower extremity arterial perfusion.	Patients will be treated twice daily for three months with the Replexa+ device. Lower extremity arterial dopplers (LEADs) will be assessed at baseline and post-treatment to determine improvement in lower extremity perfusion.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify the presence and role of inflammatory biomarkers in PAD.	Patients will undergo peripheral blood collection at baseline and post-treatment time points to compare levels of high sensitivity C-reactive protein (hsCRP).	3 months

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: ProMedTek, Inc.
• Investigators: Principal Investigator: Michael P. Murphy, MD, VA Medical Center, Indiana University

Publications and helpful links

Helpful Links

• ProMedTek, Inc. website
• FDA 510(k) Premarket Notification

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 11, 2026
• First Submitted That Met QC Criteria: January 11, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: PAD; peripheral neuropathy; peripheral artery disease; lower extremity artery disease; lower extremity neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neuromuscular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Nervous System Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: 29224

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes