Peripheral Arterial DiseaseReplexa+NCT07336381
Shortwave Diathermy In-home Treatment for Indianapolis VA-only Patients Diagnosed With Peripheral Artery Disease and Peripheral Neuropathy
A study testing Replexa shortwave diathermy in people with Peripheral Arterial Disease and Peripheral Neuropathy, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Peripheral Neuropathy
- What is being tested?
- Replexa shortwave diathermy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2026to 24 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of peripheral artery disease (PAD).
- 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.
Show all 9Show fewer
- Diagnosis of peripheral neuropathy, as evidenced by review of medical records.
- Competent to give consent.
- Age 18 years or older.
Who cannot join
- Impaired skin integrity in the location(s) to be treated.
- 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 degrees Fahrenheit or currently taking antibiotic medication(s) for an active infection.
- 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.
Show all 12Show fewer
- Pregnant individuals.
- Presence of renal disease (creatinine > 2.5 mg/dl and estimated glomerular filtration rate (eGFR) <30 mL/min) or patients on chronic hemodialysis.
- History of skeletal tuberculosis.
- Patients, in the investigator's opinion, whose index limb condition is rapidly deteriorating and may require major amputation within 30 days of screening.
- Conditions that impair cognitive function.
- Severe concomitant disease(s), or any additional condition(s) which the investigator feels constitute(s) criteria for exclusion of a particular subject.
Trial locations and contacts
1 site in 1 country.
United States1 site
Richard L. Roudebush Veterans Affairs Medical Center
Indianapolis, Indiana, 46202
About this study
Official title: An Exploratory Clinical Study Using the Replexa+ Device in Veterans With Lower Extremity Peripheral Artery Disease Experiencing Peripheral Neuropathy
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.
Read the 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 research will study the effects of the Replexa+ device, a Class II, non-invasive device that is cleared to market by the FDA (510k# K162240) and available to prescribing physicians at Veterans Affairs (VA) medical facilities. The Replexa+ device generates a form of electromagnetic energy (shortwave diathermy) to provide therapeutic heat to affected areas, deeper than infrared lights and heating pads. This type of therapeutic heat treatment has been widely used in clinical settings. The Replexa+ system consists of a generating unit (device) connected by a cable to a treatment applicator that is placed against the treated areas over normal clothing. The device operates at 27.12 megahertz (MHz), providing deep heating therapeutic effects to the body tissues.
Patients enrolled in this study will follow the manufacturer's instructions for use of the Replexa+ device and treatment. Treatment will comprise of two 30-minute sessions per day, approximately 8-12 hours apart, for 3 months, at prescribing physician-specified locations of the body.
At the post-treatment visit, the study doctor will assess the success or failure of treatment by comparing baseline measurement testing to post-treatment testing. Treatment failure will be defined as any measurable decrease in limb perfusion as evidenced by lower extremity arterial doppler testing.
- Conditions
- Peripheral Arterial Disease, Peripheral Neuropathy
- Being tested
- Replexa shortwave diathermy
- Keywords
- peripheral artery disease, peripheral neuropathy, lower extremity artery disease, lower extremity neuropathy, PAD
- Medical subject headings
- Peripheral Arterial Disease, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Replexa shortwave diathermyDevice
Treatment with home use of the Replexa+ shortwave diathermy device twice daily for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | In-home shortwave diathermy treatment. Receives: Device: Replexa shortwave diathermy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start24 Sep 2026
- Primary completion24 Sep 2026
- Study completion24 Sep 2026
Why it stopped: Funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- ProMedTek, Inc.
- Responsible party
- Principal investigator, Michael Murphy, Indiana University
- Investigators
- Michael P. Murphy, MD, Principal investigator, VA Medical Center, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336381
- Sponsor's protocol ID
- 29224
- Acronym
- Replexa+
- Status last verified
- Oct 2026
- First submitted
- 11 Jan 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study Using the Replexa+ Device in Veterans With Lower Extremity Peripheral Artery Disease Experiencing Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07336381
- Acronym / sponsor ID
- Replexa+ / 29224
- Conditions
- Peripheral Arterial Disease, Peripheral Neuropathy
- Keywords
- peripheral artery disease, peripheral neuropathy, lower extremity artery disease, lower extremity neuropathy, PAD
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- ProMedTek, Inc.
- Study start
- 24 Sep 2026 (actual)
- Primary completion
- 24 Sep 2026 (actual)
- Study completion
- 24 Sep 2026 (actual)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 research will study the effects of the Replexa+ device, a Class II, non-invasive device that is cleared to market by the FDA (510k# K162240) and available to prescribing physicians at Veterans Affairs (VA) medical facilities. The Replexa+ device generates a form of electromagnetic energy (shortwave diathermy) to provide therapeutic heat to affected areas, deeper than infrared lights and heating pads. This type of therapeutic heat treatment has been widely used in clinical settings. The Replexa+ system consists of a generating unit (device) connected by a cable to a treatment applicator that is placed against the treated areas over normal clothing. The device operates at 27.12 megahertz (MHz), providing deep heating therapeutic effects to the body tissues.
Patients enrolled in this study will follow the manufacturer's instructions for use of the Replexa+ device and treatment. Treatment will comprise of two 30-minute sessions per day, approximately 8-12 hours apart, for 3 months, at prescribing physician-specified locations of the body.
At the post-treatment visit, the study doctor will assess the success or failure of treatment by comparing baseline measurement testing to post-treatment testing. Treatment failure will be defined as any measurable decrease in limb perfusion as evidenced by lower extremity arterial doppler testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Replexa shortwave diathermyIn-home shortwave diathermy treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of peripheral artery disease (PAD).
- 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:
- 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.
Key exclusion criteria (12 listed)
- Impaired skin integrity in the location(s) to be treated.
- 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 degrees Fahrenheit or currently taking antibiotic medication(s) for an active infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Replexa shortwave diathermyTreatment with home use of the Replexa+ shortwave diathermy device twice daily for 3 months. | Device | Intervention |
Primary outcome
Compare baseline and post-treatment lower extremity arterial dopplers to determine change in lower extremity arterial perfusion.
Time frame: 3 months
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.
1 secondary outcome
Identify the presence and role of inflammatory biomarkers in PAD.
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- ProMedTek, Inc. websiteLink provided by the sponsor.
- FDA 510(k) Premarket NotificationLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Peripheral Arterial Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael P. Murphy, MD principal investigator
VA Medical Center, Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Replexa shortwave diathermy in people with Peripheral Arterial Disease and Peripheral Neuropathy, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare baseline and post-treatment lower extremity arterial dopplers to determine change in lower extremity arterial perfusion. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.