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

NCT07336381 | Recruiting DMC FDA Device

• 1 other identifier: 29224
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Neuropathy; Peripheral Arterial Disease

Keywords

peripheral artery disease; peripheral neuropathy; lower extremity artery disease; lower extremity neuropathy; PAD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Identify the presence and role of inflammatory biomarkers in PAD.

  3 months

Study Arms (1)

Intervention

EXPERIMENTAL

In-home shortwave diathermy treatment.

Device: Replexa shortwave diathermy

Interventions

Replexa shortwave diathermy DEVICE

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• ProMedTek, Inc.: collaborator

Study Sites (1)

Richard L. Roudebush Veterans Affairs Medical Center

Indianapolis, Indiana, 46202, United States

RECRUITING

Related Links

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

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Michael P. Murphy, MD

  VA Medical Center, Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristen Evans, RN, CCRC

CONTACT

317-988-9548; kristen.evans1@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 13, 2026
• Study Start: December 5, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)