Leprosy
Conditions
Interventions
This study is a randomized, controlled, within-person clinical trial. A total of 40 participants with confirmed Hansen&apos
s disease and two comparable chronic wounds will be enrolled, totaling 80 wounds. For each participant, one wound will be randomly allocated to the intervention group, comprising 40 wounds treated wit
Sponsors
Universidade Federal de Uberlândia
Universidade Federal de Uberlândia
Eligibility
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Age between 18 and 85 years; confirmed diagnosis of Hansen's disease; presence of at least two comparable chronic wounds with an area greater than or equal to 1 cm²; suspected peripheral nerve injury or presence of neuropathic symptoms; ability to understand the study information and provide written informed consent; availability to attend treatment sessions and follow-up assessments
Exclusion criteria
Exclusion criteria: Phototherapy within the 60 days preceding study enrollment; confirmed diagnosis of active systemic infection; cutaneous neoplasm in the treatment area; pregnancy or breastfeeding; known photosensitivity; clinical or cognitive conditions that preclude longitudinal follow-up, adherence to the study protocol, or adequate understanding of the study procedures; decompensated psychiatric disorders; severe decompensated comorbidities, including glycated hemoglobin levels greater than 9% and advanced renal or hepatic insufficiency; other clinical conditions that may compromise the assessment of study outcomes, as determined by the clinical care team and documented in the medical record
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A reduction in the area of chronic wounds treated with photobiomodulation therapy is expected compared with wounds receiving standard wound care alone. The primary outcome will be assessed by the percentage change in wound area measured using computerized digital planimetry with ImageJ® software, based on standardized photographs obtained before the start of the intervention and after the 90-day follow-up period | — |
Secondary
| Measure | Time frame |
|---|---|
| Neuropathic pain intensity, assessed using a standardized assessment instrument during the clinical follow-up period; quality of life, assessed using the European Health Interview Survey Quality of Life Eight Item Index before the start of the intervention and at the end of the 90-day follow-up period; health literacy, assessed using the Health Literacy Questionnaire or, when its use is not feasible, the Short Assessment of Health Literacy for Portuguese-speaking Adults, administered at baseline and at the end of the follow-up period; histopathological changes at the wound edge, assessed through biopsy specimens collected before the start of the intervention and after 90 days of follow-up; wound recurrence during the clinical follow-up period, defined as wound reopening after complete healing during the follow-up period | — |
Countries
BR
Contacts
Public ContactVanessa Freitas
Universidade Federal de Uberlândia
Outcome results
None listed