[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602421":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":38,"centralContacts":42,"locations":52,"responsibleParty":74,"collaborators":47,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":47,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":47,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":103,"overallStatus":110,"whyStopped":47,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"University of Nove de Julho","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Photobiomodulation plus Compression Therapy","EXPERIMENTAL","Participants in this arm will receive photobiomodulation therapy using a low-level laser device with 4 emitters operating at 660 nm and 808 nm wavelengths. Each emitter delivers 6 Joules of energy at 100 mW power. Treatment sessions are conducted twice weekly (Monday and Wednesday) for 16 weeks, totaling 32 sessions. In addition, standard compression therapy will be applied as per clinical guidelines for venous leg ulcers.",[13],"Device: Photobiomodulation plus Compression Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Compression Therapy plus Sham Photobiomodulation","SHAM_COMPARATOR","Participants in this arm will receive sham photobiomodulation therapy using the same laser device but without active laser emission (placebo). Treatment sessions are also conducted twice weekly for 16 weeks, totaling 32 sessions. They will also receive standard compression therapy as per clinical guidelines for venous leg ulcers.",[19],"Device: Compression Therapy plus Sham Photobiomodulation",[21,30],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","This intervention uses a low-level laser device with 8 emitters, including 4 red emitters at 660 nm and 4 infrared emitters at 808 nm. Each emitter delivers 6 Joules of energy at 100 mW power, with a total power output of 800 mW. Treatment is administered twice weekly over 16 weeks, totaling 32 sessions per participant. The device is used in combination with standard compression therapy for venous leg ulcer management.",[9],[26,27,28,29],"Low-Level Laser Therapy","Photobiomodulation","LLLT","Photobiomodulation Therapy with Low-Level Laser",{"type":22,"name":15,"description":31,"armGroupLabels":32,"otherNames":33},"This intervention uses a sham photobiomodulation therapy with the same laser device used in the active group but without emission of therapeutic laser light (inactive device). The device appears identical and the treatment sessions are conducted twice weekly over 16 weeks, totaling 32 sessions per participant. Participants also receive standard compression therapy for venous leg ulcer management. This sham procedure is designed to mimic the active treatment without delivering any laser energy, serving as a placebo control.",[15],[34,35,36,37],"Placebo Photobiomodulation","Laser Simulation","Placebo Laser Treatment","Inactive Laser Therapy",[39],{"name":40,"affiliation":5,"role":41},"Anna C Ratto Tempestini Horliana, PhD","STUDY_DIRECTOR",[43,49],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},"Rayana G Moreira, MD","CONTACT","+5514981051703",null,"rayanamoreira@hotmail.com",{"name":40,"role":45,"phone":50,"phoneExt":47,"email":51},"+5511948002288","annacrth@gmail.com",[53],{"facility":54,"status":47,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Estratégia da Saúde da Família Monte Azul - \"Antonio Benedetti\".","Lençóis Paulista","São Paulo","18682768","Brazil","BR",{"type":61,"coordinates":62},"Point",[63,64],-48.80028,-22.59861,{"lat":64,"lon":63},[67,72],{"name":68,"role":45,"phone":69,"phoneExt":70,"email":71},"Ivana O Segura Constanço","+551432644042","+5514998212434","ivanaottoboni@hotmail.com",{"name":44,"role":73,"phone":47,"phoneExt":47,"email":47},"PRINCIPAL_INVESTIGATOR",{"type":73,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":47,"oldOrganization":47},"Anna Carolina Ratto Tempestini Horliana","Professor","100602421","effect-of-photobiomodulation-on-healing-of-venous-leg-ulcers-100602421",false,"NCT07123285","Effect of Photobiomodulation on Healing of Venous Leg Ulcers","Effect of Photobiomodulation on the Healing of Venous Ulcers in the Lower Limbs","Inclusion Criteria:\n\n* Patients of both sexes;\n* Individuals with venous ulcers in the lower limbs for at least three weeks that have not healed;\n* Age between 18 and 85 years;\n* Residents of Lençóis Paulista or nearby regions.\n\nExclusion Criteria:\n\n* Patients with ulcers of non-venous etiology;\n* Pregnant women;\n* Presence of severe arterial disease in the lower limbs.","ALL","18 Years","85 Years",{"count":88,"type":89},96,"ESTIMATED","INTERVENTIONAL",[92],"NA","This randomized, controlled, double-blind clinical trial will evaluate the efficacy of photobiomodulation (PBM) combined with compression therapy in the healing of venous ulcers (VUs) in the lower limbs. A total of 96 participants will be allocated into two groups: Experimental Group (PBM + compression) and Control Group (sham PBM + compression). Treatments will be administered twice weekly for 16 weeks (32 sessions). The primary outcome will be complete wound healing. Secondary outcomes include changes in ulcer area and volume, pain (VAS), quality of life (SF-36), clinical severity (VCSS), wound quality (Bates-Jensen Scale), infrared thermography, and treatment costs. Data will be analyzed using ANOVA or Kruskal-Wallis, chi-square or Fisher's exact test, and Kaplan-Meier survival analysis, with a significance level of p \\\u003C 0.05.",[95,96,97,98,99,100,101,102],"Venous Disease","Venous Insufficiency (Chronic)(Peripheral)","Venous Insufficiency of Leg","Venous Leg Ulcer (VLU)","Venous Leg Ulcer","Venous Hypertension Ulcers","Varicose Ulcers","Varicose Ulcer of Lower Limb",[104,105,106,107,108,109],"venous ulcers","varicose ulcers","photobiomodulation","lasers","phototherapy","venous leg ulcer","NOT_YET_RECRUITING","2026-04-27",{"date":113,"type":114},"2026-04-29","ACTUAL",{"date":116,"type":89},"2026-05",{"date":118,"type":89},"2027-07",{"name":5,"class":6},1]