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.
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.
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.
Single group
Replexa shortwave diathermy
DeviceTreatment with home use of the Replexa+ shortwave diathermy device twice daily for 3 months.
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.
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).
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Indiana University
Lead sponsor
ProMedTek, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
