[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100288984":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":25,"locations":34,"responsibleParty":48,"collaborators":50,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":25,"acronym":25,"eligibilityCriteria":60,"healthyVolunteers":57,"sex":61,"minAge":62,"maxAge":25,"enrollmentInfo":63,"targetDuration":25,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":76,"whyStopped":25,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Drexel University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Low Frequency, Low Intensity Ultrasound","EXPERIMENTAL","Low Frequency, Low Intensity therapeutic ultrasound applied weekly for up to 16 weeks.",[13],"Device: Low Frequency, Low Intensity Ultrasound",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Ultrasound","SHAM_COMPARATOR","Sham ultrasound applied weekly for up to 16 weeks.",[19],"Device: Sham Applicator",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Therapeutic ultrasound (20 kHz, \\\u003C100 mW\u002Fcm2 spatial peak-temporal peak)",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Sham Applicator","Sham ultrasound applicator",[15],[31],{"name":32,"affiliation":5,"role":33},"Peter A Lewin, PhD","PRINCIPAL_INVESTIGATOR",[35],{"facility":36,"status":25,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":25},"Temple University School of Podiatric Medicine","Philadelphia","Pennsylvania","19107","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-75.16362,39.95238,{"lat":46,"lon":45},{"type":49,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[51,53],{"name":52,"class":6},"University of Pennsylvania",{"name":54,"class":6},"Temple University","100288984","enhanced-ultrasound-treatment-of-chronic-wounds-with-monitoring-of-healing-and-quality-of-life-outcomes-100288984",false,"NCT03041844","Enhanced Ultrasound Treatment of Chronic Wounds With Monitoring of Healing and Quality of Life Outcomes","Inclusion Criteria:\n\n* Have a venous ulcer (VU) or diabetic ulcer (DU) that has been documented for at least 8 weeks without complete re-epithelialization and is larger than 0.75 cm2 in size.\n* VUs must be present on the lower extremities non-weight-bearing areas.\n* DUs must be present on the ankle or foot and be secondary to complications from diabetes.\n* Patients with DUs must have a documented history of diabetes mellitus of at least six months.\n\nExclusion Criteria:\n\n* VUs secondary to any connective tissue disorder or blood dyscrasias.\n* Severe vascular insufficiency (ankle-brachial index lower than 0.75 or toe-brachial index below 0.5).\n* Active, untreated infection\n* Acute deep venous thrombosis\n* Cutaneous malignancy present on the involved extremity\n* Active (or past 6 months) cancer treatment\n* Presence of both a diabetic ulcer and a venous ulcer on the same extremity\n* Known allergy to Tegaderm (a polyurethane dressing)\n* Pregnant women\n* Individuals younger than 18 years of age regardless of emancipation status\n* Prisoners\n* Individuals unable to speak English, Spanish, or Mandarin\n* Adults unable to consent","ALL","18 Years",{"count":64,"type":65},72,"ACTUAL","INTERVENTIONAL",[68],"NA","The purpose of this study is to evaluate the effect of low frequency, low intensity ultrasound treatment on wound healing and health-related quality of life with a randomized clinical trial of patients with venous ulcers or diabetic ulcers.",[71,72],"Diabetic Foot Ulcer","Venous Ulcer",[74,75],"therapeutic ultrasound","quality of life","UNKNOWN","2022-04-05",{"date":79,"type":65},"2022-04-06",{"date":81,"type":25},"2017-01",{"date":83,"type":84},"2023-03","ESTIMATED",{"name":5,"class":6},1]