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.
• 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.
• Diagnosis of peripheral neuropathy, as evidenced by review of medical records.
• Competent to give consent.
• Age 18 years or older.