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 trial aims to determine if daily use of the Replexa+ shortwave diathermy device for three months can improve blood flow in the legs and feet of individuals with peripheral artery disease (PAD) and peripheral neuropathy. Participants will use this device at home to assess its effectiveness in managing their condition. Individuals diagnosed with PAD who experience leg pain when walking might be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance treatment options for PAD and peripheral neuropathy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Replexa+ shortwave diathermy device is safe for treating peripheral artery disease?

Studies have shown that the Replexa+ Shortwave Diathermy Device is generally well-tolerated. The FDA has cleared the device, confirming it meets safety standards for its intended use. This clearance indicates testing for safety in other conditions. Although specific side effects are not detailed, FDA clearance is reassuring.

For those considering joining a trial with this device, it is important to know that it provides deep heat therapy. This treatment is usually safe but may cause mild skin irritation or discomfort for some individuals. Discuss any concerns with healthcare professionals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for Peripheral Artery Disease (PAD) that often involve medications or invasive procedures like angioplasty, Replexa+ Shortwave Diathermy offers a non-invasive alternative that can be administered at home. This device uses shortwave diathermy, a technique that delivers deep heat to tissues, which may enhance blood flow and alleviate symptoms without the need for surgery. Researchers are excited about this treatment because it provides a convenient and potentially safer option, reducing the need for frequent hospital visits and minimizing the risks associated with more invasive procedures.

What evidence suggests that the Replexa+ shortwave diathermy device is effective for peripheral artery disease?

Research shows that shortwave diathermy, such as the Replexa+ device, can increase blood flow in the legs. One study found that patients experienced improved arterial blood flow after using shortwave diathermy compared to a placebo treatment. The Replexa+ device uses heat to enhance circulation, which can alleviate pain and reduce muscle spasms. The FDA has approved it for certain conditions, indicating its potential effectiveness. This trial will evaluate the Replexa+ device for individuals with peripheral artery disease and peripheral neuropathy, aiming to improve blood flow with this treatment. ^{1 2 5 6 7}

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?

This trial is for adults over 18 with peripheral artery disease and neuropathy, experiencing leg pain while walking. They must have specific blood flow measurements or angiographic data showing reduced perfusion, no severe diseases that could exclude them, no metal implants in the treatment area, not be pregnant, and able to consent.

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

Trial Overview

The study tests if using the Replexa+ shortwave diathermy device daily for three months can improve blood flow in lower legs and feet of patients with peripheral artery disease and neuropathy.

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

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07336381

Replexa+ Shortwave Diathermy Device for Patients ...

This research project is designed to see if treatment with the Replexa+ shortwave diathermy device daily for 3 months will improve blood flow in ...

2.

withpower.com

withpower.com/trial/phase-peripheral-arterial-disease-11-2025-8988c

Replexa+ Shortwave Diathermy for Peripheral Artery Disease

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 ...

3.

drugtrialsformoney.com

drugtrialsformoney.com/replexa-shortwave-diathermy-device-for-patients-diagnosed-with-peripheral-artery-disease-and-peripheral-neuropathy/

Replexa+ Shortwave Diathermy Device for Patients ...

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

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28460711/

Application of shortwave diathermy to lower limb increases ...

Results: Arterial blood flow increased after SWD diathermy (vs. Sham), but not after MWD diathermy. SWD promoted skin heating at the end of ...

5.

promedtek.com

promedtek.com/technology/

Technology - ProMedTekProMedTek

Replexa+ is a thermal shortwave diathermy device that the FDA has cleared to treat selected medical conditions such relieving pain, reducing muscle spasm.

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf16/K162240.pdf

Revised 510(k) Summary_Nov 15 - accessdata.fda.gov

“The ProMedTek Model C1400 Shortwave Diathermy device delivers energy in the radio band of. 27.12 MHz to provide deep heating therapeutic ...

7.

promedtek.com

promedtek.com/wp-content/uploads/2024/05/Replexa-510k-Clearance-Letter.pdf

Replexa-510k-Clearance-Letter.pdf

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and ...