Replexa+ Shortwave Diathermy for Peripheral Artery Disease

(Replexa Trial)

Overseen By Kristen Evans, RN, CCRC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must not be taking: Antibiotics

Disqualifiers: Active infection, Renal disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Michael P. Murphy, MD

Principal Investigator

VA Medical Center, Indiana University

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with peripheral artery disease.

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

Exclusion Criteria

Severe concomitant disease(s), or any additional condition(s) which the investigator feels constitute(s) criteria for exclusion of a particular subject

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive in-home shortwave diathermy treatment with the Replexa+ device twice daily for 3 months

12 weeks

Daily in-home sessions

Post-treatment assessment

The study doctor assesses treatment success or failure by comparing baseline and post-treatment lower extremity arterial doppler tests

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Replexa+ Shortwave Diathermy Device

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

In-home shortwave diathermy treatment.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

ProMedTek, Inc.

Collaborator