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Clinical Trial NCT07336381 (Replexa) for Peripheral Arterial Disease, Peripheral Neuropathy is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Replexa+ Shortwave Diathermy Device for Patients Diagnosed With Peripheral Artery Disease and Peripheral Neuropathy 10

Recruiting
Clinical Trial NCT07336381 (Replexa) is an interventional study for Peripheral Arterial Disease, Peripheral Neuropathy that is recruiting. It started on December 5, 2025 with plans to enroll 10 participants. Led by Indiana University, it is expected to complete by December 31, 2026. The latest data from ClinicalTrials.gov was last updated on January 15, 2026.
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.
Detailed Description
This is a single-site, non-randomized, open label, exploratory clinical trial to evaluate the effects of the Replexa+ shortwave diathermy treatment in patients diagnosed with peripheral artery disease (PAD) and peripheral neuropathy. This pilot study will examine changes in lower extremity perfusion in a total of ten (10) Veteran patients at the Roudebush VA Medical Center in Indianapolis, Indiana, USA.

The proposed...

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Official Title

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

Conditions
Peripheral Arterial DiseasePeripheral Neuropathy
Other Study IDs
  • Replexa
  • 29224
NCT ID Number
NCT07336381
Start Date (Actual)
2025-12-05
Last Update Posted
2026-01-15
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
10
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
peripheral artery disease
peripheral neuropathy
lower extremity artery disease
lower extremity neuropathy
PAD
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalIntervention
In-home shortwave diathermy treatment.
Replexa shortwave diathermy
Treatment with home use of the Replexa+ shortwave diathermy device twice daily for 3 months.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Identify the presence and role of inflammatory biomarkers in PAD.
Patients will undergo peripheral blood collection at baseline and post-treatment time points to compare levels of high sensitivity C-reactive protein (hsCRP).
3 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  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.

  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.
Indiana University logoIndiana University
ProMedTek, Inc. logoProMedTek, Inc.
Study Responsible Party
Michael Murphy, Principal Investigator, MD, Indiana University
Study Central Contact
Contact: Kristen Evans, RN, CCRC, 317-988-9548, [email protected]
1 Study Locations in 1 Countries

Indiana

Richard L. Roudebush Veterans Affairs Medical Center, Indianapolis, Indiana, 46202, United States
Kristen Evans, RN, CCRC, Contact, 317-988-9548, [email protected]
Michael P. Murphy, MD, Principal Investigator
Recruiting