Shortwave Diathermy In-home Treatment for Indianapolis VA-only Patients Diagnosed With Peripheral Artery Disease and Peripheral Neuropathy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University

About 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.

Eligibility criteria

Qualifiers

Diagnosis of peripheral artery disease (PAD).

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

Diagnosis of peripheral neuropathy, as evidenced by review of medical records.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Replexa shortwave diathermy

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators

Indiana University

Lead sponsor

ProMedTek, Inc.

Collaborator