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
Sponsors and collaborators
Indiana University
Lead sponsor
ProMedTek, Inc.
Collaborator