Leg Ulcer Wound Healing
Conditions
Interventions
This is a prospective, randomized, controlled, assessor-blinded clinical trial with two parallel arms, involving 40 patients with chronic ulcers, allocated into two groups (n = 20 per group). Group 1
Sponsors
Instituto de Ensino Superior de Indaiatuba LTDA
Orthoregen - Ensino e Pesquisa Em Medicina Regenerativa do Aparelho Locomotor LTDA
Eligibility
Age
No minimum to 80 Years
Inclusion criteria
Inclusion criteria: Chronic wound etiology; age up to 80 years; minimum wound area of 10 square centimeters
Exclusion criteria
Exclusion criteria: Underlying conditions that may impair wound healing; patients with malignant neoplasm within the last five years; smokers; systemic lupus erythematosus; patients with three consecutive absences or six alternating absences, and those who do not agree to participate in the study of their own free will; uncontrolled systemic arterial hypertension; acquired immunodeficiency syndrome; anemia; stroke or acute myocardial infarction within the last three months; renal insufficiency (creatinine greater than two milligrams per deciliter); liver disease (aspartate aminotransferase greater than two times the upper limit of normal, international normalized ratio greater than 1,5); major surgery or major trauma within the last two months; pregnant women; intellectual disability; participation in other studies within the last thirty days. Patients undergoing other wound-healing therapies will not be included and will remain on their treatment of choice
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy of the treatment in promoting chronic ulcer healing is expected to be evaluated by measuring lesion area using the wound contour mapping method as described by Huber et al. (2019), based on the observation of the percentage reduction in ulcer area at baseline, 3 months, and 6 months, considering a positive outcome as a reduction of at least 50 percent of the initial area or complete wound healing. | — |
Secondary
| Measure | Time frame |
|---|---|
| The time to complete ulcer closure is expected to be evaluated by clinical follow-up with monthly macroscopic assessment of the lesion, based on the observation of the number of weeks until complete healing, considering as parameter the total time until complete wound closure or up to the maximum period of 6 months;Quality of life in patients undergoing treatment is expected to be evaluated by applying the SF-36 questionnaire at baseline, 3 months, and 6 months, based on the observation of increased scores across the evaluated domains, considering a positive outcome as improvement in scores compared with baseline values;Pain intensity associated with chronic ulcers is expected to be evaluated by applying the Visual Analog Scale (VAS) at baseline, 3 months, and 6 months, based on the observation of reduced pain scores, considering a positive outcome as a decrease of at least 2 points on the scale;Tissue perfusion in the affected area is expected to be evaluated by monthly thermographic assessment of the affected limb, based on the observation of temperature variations in the lesion region, considering a positive outcome as an increase in local temperature indicative of improved tissue perfusion;The difference in efficacy between treatment with platelets rich plasma alone and platelets rich plasma combined with bone marrow aspirate is expected to be evaluated by comparing ulcer area reduction and healing time throughout follow-up, based on the observation of percentage differences between groups, considering a positive outcome as superiority of one treatment over the other. | — |
Countries
BR
Contacts
Public ContactJosé Fabio Lana
Orthoregen - Ensino e Pesquisa Em Medicina Regenerativa do Aparelho Locomotor LTDA
Outcome results
None listed