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

A vizsgálat adatai

Ki végzi

Indiana University

Azonosító

NCT07336381

A regiszteradat frissítve

2026. október 29.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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.

Bevonási feltételek: 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.

Kizáró feltételek: Existence of metal hardware in the area(s) to be treated: Any patient with implanted electronic or metal device such as a pacemaker, bladder stimulator, spinal cord stimulator or electrodes for a myoelectric prosthesis, IUD, surgical staples or implanted metallic leads; Severe concomitant disease(s), or any additional condition(s) which the investigator feels constitute(s) criteria for exclusion of a particular subject; Diagnosis of active bleeding tendencies, hemorrhage, or thrombosis; History of skeletal tuberculosis; Patients, in the investigator's opinion, whose index limb condition is rapidly deteriorating and may require major amputation within 30 days of screening; Conditions that impair cognitive function; Active infection defined as elevated white blood cell count >11,500/µL or fever >101.5 degrees Fahrenheit or currently taking antibiotic medication(s) for an active infection; Presence of renal disease (creatinine > 2.5 mg/dl and estimated glomerular filtration rate (eGFR) <30 mL/min) or patients on chronic hemodialysis; Impaired skin integrity in the location(s) to be treated; Current wounds or ulcerations; 2+ pitting edema in either lower extremity; Pregnant individuals.

ClinicalTrials.gov NCT07336381