Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07336381

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

Led by Indiana University · Updated on 2026-01-15

10

Participants Needed

1

Research Sites

55 weeks

Total Duration

On this page

Sponsors

I

Indiana University

Lead Sponsor

P

ProMedTek, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of peripheral artery disease (PAD).
  • Claudication of the index limb (Rutherford Category 2 or 3) with documented pain when walking.
  • Ankle brachial index (ABI) greater than or equal to 0.6 mmHg measured within 6 months prior to screening or resting toe brachial index (TBI) greater than or equal to 0.4 measured within 6 months prior to screening.
  • If ankle and toe systolic pressures are unavailable due to calcification or toe amputation, angiographic data is acceptable to determine blockages or reduced perfusion.
  • Diagnosis of peripheral neuropathy confirmed by medical record review.
  • Able to give consent.
  • Age 18 years or older.
Not Eligible

You will not qualify if you...

  • Impaired skin integrity in the treatment location(s).
  • Current wounds or ulcerations.
  • Diagnosis of active bleeding tendencies, hemorrhage, or thrombosis.
  • 2+ pitting edema in either lower extremity.
  • Active infection defined as elevated white blood cell count >11,500/µL or fever >101.5°F or currently taking antibiotics for infection.
  • Presence of implanted electronic or metal devices such as pacemaker, bladder stimulator, spinal cord stimulator, electrodes for myoelectric prosthesis, IUD, surgical staples, or metallic leads in the treatment area.
  • Pregnancy.
  • Renal disease with creatinine >2.5 mg/dl or eGFR <30 mL/min, or receiving chronic hemodialysis.
  • History of skeletal tuberculosis.
  • Rapidly deteriorating limb condition that may require major amputation within 30 days.
  • Conditions impairing cognitive function.
  • Severe additional diseases or conditions that the investigator considers exclusion criteria.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Richard L. Roudebush Veterans Affairs Medical Center

Indianapolis, Indiana, United States, 46202

Actively Recruiting

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Research Team

K

Kristen Evans, RN, CCRC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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