Varicose Ulcer
Conditions
Interventions
This is a three-arm, randomized controlled trial, double blind. The sample consisted of 150 subjects, equally distributed among the control group, the methylene blue photodynamic therapy group, and th
Sponsors
Universidade São Francisco
Prefeitura da Estância de Atibaia
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adults over 18 years of age with complex wounds of the following etiologies: lower limb lesions in diabetics, lesions due to peripheral vascular insufficiency; Complex wounds defined as wounds that did not show significant improvement in healing after 4 weeks of conventional treatment; Research subjects available for follow-up during the 3-year study period; Those who consent to a biopsy of the lesion and agree to blinding; Those who sign the Informed Consent Form
Exclusion criteria
Exclusion criteria: Subjects with wounds that have a malignant etiology or suspected malignancy; Subjects with uncontrolled chronic diseases that may affect wound healing, e.g., uncontrolled diabetes, severe vascular disease, severe anemia, malnutrition; Subjects with clinical contraindication to lower limb biopsy, carriers of arterial compromise, identified in the Ankle-Brachial Index. Values ??below 0.9 or above 1.3 may indicate arterial problems; Subjects who received photobiomodulation treatment or similar adjuvant therapies in the last 4 weeks prior to inclusion in the study; Patients with a history of allergy or known sensitivity to the components of the treatment dressings, photosensitizer, or anesthetic used in this study; Subjects who have coagulation problems or who use anticoagulants and cannot discontinue them for the biopsy. Pregnant or lactating patients; Patients unable to understand or meet the requirements of the study; Expressing a desire, at any time during the study, to abandon treatment; No effective response or clinical worsening after three months of treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that the biofilm and infection will be controlled by clinical markers and inflammatory biomarkers such as Interleukin 1 beta, chemokines, and metalloproteinases;Wound healing is expected to be achieved, as assessed by applying the Bates-Jensen Wound Assessment tool every 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvements in quality of life are expected to be assessed based on the criteria of the Cardiff Wound Impact Schedule (CWIS) instrument.;Pain control is expected to be assessed using the McGill Pain Questionnaire Short Form (McGill Reduced). | — |
Countries
BR
Contacts
Public ContactIrene Prado
Prefeitura da Estância de Atibaia
Outcome results
None listed