Indiana University
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.
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 physician…
Inclusion Criteria: 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 c…
Treatment with home use of the Replexa+ shortwave diathermy device twice daily for 3 months.
Arctuva estimate
Verify or correct the compensation shown for this listing.