[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100340717":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":66,"collaborators":26,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":26,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":26,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Laser Treatment","EXPERIMENTAL","Summus Laser treatment with infrared light",[13],"Device: Summus Laser",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham treatment","SHAM_COMPARATOR","Sham Summus Laser treatment with no infrared light",[19],"Device: Summus Laser Sham",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Summus Laser","infrared laser treatment",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Summus Laser Sham","non-infrared light",[15],[32],{"name":33,"affiliation":34,"role":35},"Joseph Molnar, MD","WFUHS","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Renea D Jennings, RN","CONTACT","336-716-6709","rjenning@wakehealth.edu",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Caleb Suggs","336-713-4339","csuggs@wakehealth.edu",[47],{"facility":5,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Winston-Salem","North Carolina","27157","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-80.24422,36.09986,{"lat":58,"lon":57},[61,62,63,64],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":65,"role":35,"phone":26,"phoneExt":26,"email":26},"Lucian Vlad, MD",{"type":67,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100340717","randomized-controlled-trial-for-treatment-of-pain-and-assessment-of-wound-healing-in-chronic-venous-leg-ulcers-using-near-infrared-laser-therapy-100340717",false,"NCT03716167","Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers Using Near Infrared Laser Therapy","Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers","Inclusion Criteria:\n\n* 18 yo or older\n* Venous insufficiency documented on basis of Venous Insufficiency US or on basis of skin changes c\u002Fw stasis\n* Ulcer location in area of stasis present on lower limb\n* Ulcer surface greater or equal to 5 cm2 but no larger than 140 cm2 after the initial debridement\n* Ankle brachial index (ABI) \\> 0.8\n* Ulcer duration longer than 4 weeks\n* Pain scale assessment per visual analog scale at, or above, 2 at initial visit for the study\n\nExclusion Criteria:\n\n* Pregnant, nursing or child bearing potential\n* Venous ablation past 6 weeks and duration of study\n* Autoimmune disorder\n* Immune suppressive meds, Including steroids\n* Any other co-playing comorbidities into wound etiology (neuropathy with pressure reinjury or uncontrolled diabetes with Hb A1c \\> 9)\n* Use of bioengineered products 30 days before and during the duration of study\n* 15\\\u003CBMI \\\u003C50\n* Use of oral or IV administered antibiotics within one week prior to randomization\n* Having tattoos in the region of skin above or adjacent to the ulcer where laser light might be applied.",true,"ALL","18 Years",{"count":79,"type":80},20,"ESTIMATED","INTERVENTIONAL",[83],"NA","The laser emits an infrared light that heats the skin and underlying tissues with the purpose of temporary relief of minor muscle and joint pain, as well as stiffness associated with arthritis. The laser also causes a temporary increase in blood flow. The purpose of this study is to evaluate whether laser therapy can provide pain relief and speed the healing of venous leg ulcers.",[86],"Venous Leg Ulcer",[88,89,90],"laser","ulcer","wound","2025-08-26",{"date":93,"type":94},"2025-08-28","ACTUAL",{"date":96,"type":94},"2018-07-27",{"date":98,"type":80},"2026-10",{"name":5,"class":6},1]