Wounds and Injuries
Conditions
Interventions
This is an open-label, two-arm, randomized clinical trial with a blinded outcome, aiming to compare the treatment outcomes of people with foot ulcers related to Diabetes Mellitus (DM) in two parallel
Sponsors
Centro de Ciências da Saúde - Universidade Federal de Santa Catarina
FAPESC - Fundação de Amparo à Pesquisa e Inovação do Estado de Santa Catarina
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Be over 18 years of age; regardless of gender; have a medical diagnosis of Diabetes Mellitus with a foot ulcer or lesion resulting from foot amputation related to Diabetes Mellitus; not be undergoing treatment with Autologous Leukocyte Platelet Fibrin Matrix; be available to attend the health service once a week
Exclusion criteria
Exclusion criteria: Pregnancy; lesions suspected of being malignant; significant anemia; wound with active bleeding; continuous use of anticoagulant medication; Ankle Brachial Index values ??indicating severe ischemia; active infection; antibiotic use in the last month; chronic kidney disease; blood borne diseases; ulcers larger than 49 cm2; individuals with any type of reported allergy to the products of the therapies used in treatment (dressings/wound dressings)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure the size of the lesion (in square centimeters - cm² and cubic volume - cm³). Primary outcome, continuous quantitative variable, obtained by measuring the lesion every 4 weeks using a millimeter ruler. The area is calculated using the formula: greatest length of the lesion multiplied by the greatest width. The volume is calculated using the formula: greatest length of the lesion multiplied by the greatest width multiplied by the greatest depth. According to the Bates-Jensen Wound Assessment Tool (BWAT), it may receive a score of: 1 point for lesions smaller than 4 cm²; 2 points for sizes between 4 and 16 cm²; 3 points for sizes between 16.1 and 36 cm²; 4 points for sizes between 36.1 and 80 cm²; and 5 points for lesions larger than 80 cm². Continuous variables with an asymmetrical distribution will be presented as median and interquartile range, using the Mann-Whitney test (or Kruskal-Wallis test, when appropriate) for comparison between groups. A decrease in lesion size and a decrease in the score received for this outcome are expected. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the type of necrotic tissue in the lesion. This is a secondary outcome, a nominal categorical variable, clinically assessed (measured) by inspection, characterized by the presence of non-viable tissue in the wound bed. According to the Bates-Jensen Wound Assessment Tool (BWAT), it may receive a score based on its characterization: 1 point for absence; 2 points for the presence of non-viable white/gray tissue or non-adherent yellowish slough; 3 points for slightly adherent yellowish slough; 4 points for adherent yellowish slough; and 5 points for a black, hard, fully adherent eschar. Nominal categorical variables will be described by absolute and relative frequencies (proportions), and compared using the chi-square or Fisher's exact test. Absence is expected over the follow-up period and/or a decrease in the score received for this outcome.;Measuring the amount of necrotic tissue in the lesion. Secondary outcome, nominal categorical variable, clinically assessed (measured) by inspection, characterized by the proportion of the lesion area with non-viable tissue in its bed. According to the Bates-Jensen Wound Assessment Tool (BWAT), it may receive a score value, according to its characterization: 1 point for 0% of the wound covered; 2 points for less than 25% of the wound covered; 3 points when between 25% and 50% of the wound covered; 4 points when between 51% and 75% of the wound covered; and 5 points when between 75% and 100% of the wound covered. Nominal categorical variables will be described by absolute and relative frequencies (proportions), being compared by the chi-square or Fisher's exact test. It is expected to observe absence (0%) over the follow-up period and/or a decrease in the score received for this outcome.;Assess granulation tissue in the wound. Secondary outcome, nominal categorical variable, clinically assessed by inspection, characterized by the presence of granulation tissue in the wound bed. According to the Bates-Jensen Wound A | — |
Countries
BR
Contacts
Public ContactMilena Pereira
Universidade Federal de Santa Catarina
Outcome results
None listed