[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602421":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":45,"centralContacts":49,"locations":58,"responsibleParty":78,"collaborators":44,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":44,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":44,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":103,"overallStatus":109,"whyStopped":44,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"University of Nove de Julho","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Photobiomodulation","EXPERIMENTAL","The e-Light IRL cluster device (DMC Equipamentos, Brazil; ANVISA No. 80030810174) contains eight emitters: four at 660 nm and four at 808 nm. Each emitter has an output power of 100 mW and delivers 6 J over 60 seconds. Total output power is 800 mW. The applicator will be positioned perpendicular to the wound bed and applied by direct contact through disposable transparent PVC film. Appropriate protective eyewear will be used.",[13,14],"Device: Photobiomodulation Therapy","Procedure: Compression Therapy",{"label":16,"type":17,"description":18,"interventionNames":19},"Sham Photobiomodulation","SHAM_COMPARATOR","The same device positioning and application duration will be used, but the device will remain switched off and will not emit therapeutic light. Participants will wear an eye covering, and a recorded sound similar to the operating device will be reproduced to maintain blinding.",[20,14],"Device: Sham Photobiomodulation",[22,31,39],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DEVICE","Photobiomodulation Therapy","The e-Light IRL cluster device (DMC Equipamentos, Brazil; ANVISA No. 80030810174) contains eight emitters: four at 660 nm and four at 808 nm. Each emitter has an output power of 100 mW and delivers 6 J over 60 seconds. Total output power is 800 mW. The applicator will be positioned perpendicular to the wound bed and applied by direct contact through disposable transparent PVC film. Appropriate protective eyewear will be used. Participants will receive active photobiomodulation twice weekly on Mondays and Thursdays for 16 weeks, totaling 32 sessions.",[9],[28,9,29,30],"Low-Level Laser Therapy","LLLT","Photobiomodulation Therapy with Low-Level Laser",{"type":23,"name":16,"description":32,"armGroupLabels":33,"otherNames":34},"This intervention uses sham photobiomodulation therapy with the same laser device as in the active group, but without emitting 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 the management of venous leg ulcers. This sham procedure is designed to mimic the active treatment without delivering any laser energy, serving as a placebo control.",[16],[35,36,37,38],"Placebo Photobiomodulation","Laser Simulation","Placebo Laser Treatment","Inactive Laser Therapy",{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"PROCEDURE","Compression Therapy","All study participants received standardized wound care and compression therapy using 30-mmHg compression stockings.",[9,16],null,[46],{"name":47,"affiliation":5,"role":48},"Anna C Ratto Tempestini Horliana, PhD","STUDY_DIRECTOR",[50,55],{"name":51,"role":52,"phone":53,"phoneExt":44,"email":54},"Rayana G Moreira, MD","CONTACT","+5514981051703","rayanamoreira@hotmail.com",{"name":47,"role":52,"phone":56,"phoneExt":44,"email":57},"+5511948002288","annacrth@gmail.com",[59],{"facility":60,"status":44,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Estratégia Saúde da Família Vereador Carlos Alberto Baptistela - Maria Cristina","Lençóis Paulista","São Paulo","18681-160","Brazil","BR",{"type":67,"coordinates":68},"Point",[69,70],-48.80028,-22.59861,{"lat":70,"lon":69},[73,76],{"name":74,"role":52,"phone":75,"phoneExt":44,"email":54},"Rayana O G. Moreira, MD","+55 14 98105-1703",{"name":51,"role":77,"phone":44,"phoneExt":44,"email":44},"PRINCIPAL_INVESTIGATOR",{"type":77,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"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 Lower-Limb Venous Ulcers: A Randomized, Double-Blind, Controlled Clinical Trial","Inclusion Criteria\n\n* Participants of either sex.\n* Age 19 to 85 years.\n* Lower-limb venous ulcer present for at least 6 weeks and not healed.\n* Ulcer without infection at enrollment.\n\nOperational confirmation before enrollment:\n\n* Venous etiology confirmed by Doppler ultrasonography demonstrating venous reflux.\n* Ankle-Brachial Index ≥0.8 to exclude concomitant arterial disease.\n* Written informed consent.\n\nExclusion Criteria\n\n* Ulcer of non-venous etiology.\n* Pregnancy.\n* Severe lower-limb arterial disease.\n* Current use or initiation of another venous-ulcer treatment different from the study treatment.\n\nProtocol Discontinuation Criteria\n\n* Wound worsening with onset of infection.\n* Any complication during the procedure requiring discontinuation for participant safety.","ALL","19 Years","85 Years",{"count":92,"type":93},102,"ESTIMATED","INTERVENTIONAL",[96],"NA","Venous leg ulcers are a significant public health problem because of their prolonged duration, high recurrence rates, and economic, social, and quality-of-life effects. Compression therapy is the standard treatment; however, healing may remain slow. Photobiomodulation is being investigated as an adjunctive treatment to promote tissue repair and wound healing.\n\nThis prospective, randomized, controlled, double-blind clinical trial will evaluate the efficacy of photobiomodulation combined with compression therapy in the healing of lower-limb venous leg ulcers. A total of 102 participants will be randomly allocated in a 1:1 ratio to an Experimental Group (n=51), receiving active photobiomodulation plus compression therapy, or a Control Group (n=51), receiving sham photobiomodulation plus compression therapy. Treatment will be administered twice weekly on Mondays and Thursdays for 16 weeks, totaling 32 sessions.\n\nThe primary outcome will be the percentage reduction in wound volume over 16 weeks, estimated from wound area and depth. Secondary outcomes will include percentage reduction in wound area, change in wound depth, complete wound healing, adverse events, wound quality assessed using the Bates-Jensen Wound Assessment Tool, pain intensity and rescue analgesic use, health-related quality of life assessed using the SF-36, clinical severity assessed using the Venous Clinical Severity Score, and direct treatment costs. Wound area will be measured using the ImitoWound® application.",[99,100,101,102],"Venous Leg Ulcer (VLU)","Venous Hypertension Ulcers","Chronic Venous Insufficiency","Chronic Venous Disease",[104,105,28,41,106,107,108],"venous ulcers","photobiomodulation","Venous Ulcer","Venous Leg Ulcer","Wound Healing","NOT_YET_RECRUITING","2026-07-28",{"date":112,"type":113},"2026-07-30","ACTUAL",{"date":115,"type":93},"2026-08",{"date":117,"type":93},"2027-07",{"name":5,"class":6},1]