Ulcer. Leg Ulcer. Foot Ulcer. Diabetes Mellitus
Conditions
Interventions
This study is designed as a randomized, controlled, parallel-group clinical trial with a 1:1 allocation ratio, conducted to evaluate the efficacy of photodynamic therapy in promoting the healing of ne
Sponsors
Fundação do ABC
Fundação do ABC
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: individuals of both sexes; participants aged over 18 years; diagnosis of diabetes mellitus; presence of diabetic neuropathy; presence of lower limb ulceration; blood glucose less than 140 mg/dL; absence of venous hypertension; absence of peripheral arterial obstructive disease
Exclusion criteria
Exclusion criteria: presence of clinical signs of peripheral vascular insufficiency; requirement for prior revascularization before treatment; pregnant women; breastfeeding women; individuals with photosensitivity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of photodynamic therapy in promoting the healing of neuropathic lower limb ulcers in individuals with diabetes mellitus, as determined by the percentage reduction in lesion area over a six month follow up period. The outcome will be assessed through biweekly planimetric measurement of the ulcer area using a graduated transparent film for lesion demarcation, combined with standardized photographic documentation employing a fixed metric scale. The ulcer area will be calculated in square centimeters (cm²) and monitored longitudinally throughout the intervention period. The percentage reduction in ulcer area will be calculated using the formula initial area minus final area divided by the initial area multiplied by one hundred. Absolute area values, percentage change over time, and between-group comparisons at the end of the six month follow up will be analyzed. This outcome constitutes the primary endpoint for estimating the effect of the intervention and assessing its therapeutic efficacy | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the time required to achieve complete ulcer healing in the control and experimental groups. This outcome will be assessed through biweekly clinical evaluations, including direct inspection of the lesion and standardized photographic documentation. Complete healing will be defined as full re-epithelialization of the ulcer, with no evidence of exudate or devitalized tissue. The number of days to complete healing and the proportion of participants achieving total wound closure within the six-month follow-up period will be analyzed | — |
Countries
BR
Contacts
Public ContactAndré Martins de Oliveira
Fundação do ABC
Outcome results
None listed