Replexa+ shortwave diathermy for people with peripheral artery disease and peripheral neuropathy

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

This pilot will test whether daily Replexa+ shortwave diathermy for 3 months can improve blood flow in the lower legs and feet of veterans with peripheral artery disease and peripheral neuropathy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Indiana University (Academic / other)
• Locations: 1 site (Indianapolis, Indiana)
• Trial ID: NCT07336381 on ClinicalTrials.gov

What this trial studies

This single-site, non-randomized, open-label pilot will enroll ten Veteran patients at the Roudebush VA Medical Center in Indianapolis to measure changes in lower-extremity perfusion after treatment. The intervention uses the FDA-cleared Replexa+ device, which delivers shortwave diathermy (27.12 MHz) as deep therapeutic heat applied over normal clothing. Participants will follow the manufacturer’s instructions for two 30-minute sessions per day, approximately 8–12 hours apart, for three months at physician-specified treatment locations. Perfusion and clinical measures will be collected before and after the treatment period to explore whether the device increases blood flow in affected legs and feet.

Who should consider this trial

Good fit: Ideal candidates are adults with a documented diagnosis of peripheral artery disease (claudication, Rutherford category 2–3 with ABI ≥0.6 or TBI ≥0.4) and documented peripheral neuropathy who can give consent and comply with twice-daily treatments.

Not a fit: Patients who fall outside the enrollment thresholds (for example ABI or TBI below the stated cutoffs), who have impaired skin integrity or other exclusion conditions that prevent device use, or who cannot follow the twice-daily regimen are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the treatment could improve blood flow in the lower legs and feet, which may reduce walking pain and help with tissue health in affected patients.

How similar studies have performed: Shortwave diathermy and other deep-heat therapies have long been used clinically for tissue heating, but high-quality evidence specifically showing improved limb perfusion in PAD is limited, making this an exploratory application.

Eligibility criteria

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.

Where this trial is running

Indianapolis, Indiana

• Richard L. Roudebush Veterans Affairs Medical Center — Indianapolis, Indiana, United States (Recruiting)

Study contacts

• Principal investigator: Michael P. Murphy, MD — VA Medical Center, Indiana University
• Study coordinator: Kristen Evans, RN, CCRC

Conditions Peripheral Arterial Disease; Peripheral Neuropathy; peripheral artery disease; peripheral neuropathy; lower extremity artery disease; lower extremity neuropathy; PAD