[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618804":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":49,"collaborators":52,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":20,"enrollmentInfo":66,"targetDuration":20,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":82,"whyStopped":20,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Indiana University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","In-home shortwave diathermy treatment.",[13],"Device: Replexa shortwave diathermy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Replexa shortwave diathermy","Treatment with home use of the Replexa+ shortwave diathermy device twice daily for 3 months.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Michael P. Murphy, MD","VA Medical Center, Indiana University","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Kristen Evans, RN, CCRC","CONTACT","317-988-9548","kristen.evans1@va.gov",[33],{"facility":34,"status":20,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Richard L. Roudebush Veterans Affairs Medical Center","Indianapolis","Indiana","46202","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-86.15804,39.76838,{"lat":44,"lon":43},[47,48],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":25,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Michael Murphy","MD",[53],{"name":54,"class":55},"ProMedTek, Inc.","UNKNOWN","100618804","shortwave-diathermy-in-home-treatment-for-indianapolis-va-only-patients-diagnosed-with-peripheral-artery-disease-and-peripheral-neuropathy-100618804",false,"NCT07336381","Shortwave Diathermy In-home Treatment for Indianapolis VA-only Patients Diagnosed With Peripheral Artery Disease and Peripheral Neuropathy","An Exploratory Clinical Study Using the Replexa+ Device in Veterans With Lower Extremity Peripheral Artery Disease Experiencing Peripheral Neuropathy","Replexa+","Inclusion Criteria:\n\n1. Diagnosis of peripheral artery disease (PAD).\n2. Participants must exhibit PAD severity, defined by the following manifestation and corresponding Rutherford classifications:\n\n   Claudication of the index limb (Rutherford Category 2 or 3- documented as pain with walking) in conjunction with one or more of the following:\n   * ankle brachial index (ABI) greater than or equal to 0.6 mmHg, as measured no more than 6 months prior to screening\n   * resting toe brachial index (TBI) greater than or equal to 0.4, as measured no more than 6 months prior to screening\n\n   Note: In cases where ankle and toe systolic pressures are unavailable due to calcification and\u002For toe amputation, collection of angiographic data is acceptable to determine locations of blockages or reduced perfusion.\n3. Diagnosis of peripheral neuropathy, as evidenced by review of medical records.\n4. Competent to give consent.\n5. Age 18 years or older.\n\nExclusion Criteria:\n\n1. Impaired skin integrity in the location(s) to be treated.\n2. Current wounds or ulcerations.\n3. Diagnosis of active bleeding tendencies, hemorrhage, or thrombosis.\n4. 2+ pitting edema in either lower extremity.\n5. Active infection defined as elevated white blood cell count \\>11,500\u002FµL or fever \\>101.5 degrees Fahrenheit or currently taking antibiotic medication(s) for an active infection.\n6. 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.\n7. Pregnant individuals.\n8. Presence of renal disease (creatinine \\> 2.5 mg\u002Fdl and estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin) or patients on chronic hemodialysis.\n9. History of skeletal tuberculosis.\n10. Patients, in the investigator's opinion, whose index limb condition is rapidly deteriorating and may require major amputation within 30 days of screening.\n11. Conditions that impair cognitive function.\n12. Severe concomitant disease(s), or any additional condition(s) which the investigator feels constitute(s) criteria for exclusion of a particular subject.","ALL","18 Years",{"count":67,"type":68},10,"ESTIMATED","INTERVENTIONAL",[71],"NA","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.",[74,75],"Peripheral Arterial Disease","Peripheral Neuropathy",[77,78,79,80,81],"peripheral artery disease","peripheral neuropathy","lower extremity artery disease","lower extremity neuropathy","PAD","NOT_YET_RECRUITING","2026-05-27",{"date":85,"type":86},"2026-05-29","ACTUAL",{"date":88,"type":68},"2026-07-01",{"date":90,"type":68},"2027-12-31",{"name":5,"class":6},1]