Diabetic foot
Conditions
Interventions
This is a controlled clinical study with 3 arms. For this study, 50 patients will be recruited, who will be allocated into the groups according to prior randomization. The sample size calculation was
Group 2:
E02.186.500
Sponsors
Hospital Universitário do Oeste do Paraná
Hospital Universitário do Oeste do Paraná
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Individuals aged 18 years or older (men and women); who have 1 or more infected ulcers on the foot, present for at least 2 months and a maximum of 24 months, ulcer size from 1 to 100 cm2; who have an ankle-brachial pressure index greater than or equal to 0.80
Exclusion criteria
Exclusion criteria: Patients with known hypersensitivities or allergies to the dressing materials used in the study; patients undergoing recent or active cancer treatment; patients with severe malnutrition; patients with ulcers diagnosed as malignant; patients with systemic infection treated with continuous antibiotics (local and/or systemic antibiotics) for more than 5 consecutive days and in the last 5 days prior to treatment; patients who have used corticosteroids (local or systemic) in the 5 days prior to treatment; uncontrolled diabetes with glycated hemoglobin: Hb A1c greater than or equal to 10; chronic diseases that impair wound healing: autoimmune disorder in an acute flare-up phase, chronic kidney disease, and peripheral vascular insufficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total bacterial load of the ulcers will be assessed using tissue culture and microbiological quantification of microorganisms through the blood agar culture technique. The microbial load will be measured in colony-forming units (CFU) per gram of tissue, based on the number of colonies counted, the weight of the analyzed tissue sample, and the sample dilution. This result will be compared at three time points: before treatment, after 15 days, and after 30 days, allowing for the calculation of mean differences between the evaluated periods and treatment groups | — |
Secondary
| Measure | Time frame |
|---|---|
| For the outcome "ulcer area," measurement will be performed using two methods: a digital method with the ImageJ software (Java-based Image Processing Program) and a manual method using a disposable measuring tape. Measurements will be taken in two directions (length × width) to determine the percentage of ulcer closure. The disposable measuring tape will be used directly on the skin for manual measurements. The percentage of closure (ulcer contraction index – UCI) will be calculated using the following formula: UCI = (initial area - final area) / initial area, where: UCI = 1 indicates complete re-epithelialization; UCI = 0 indicates no signs of re-epithelialization; UCI > 0 indicates a reduction in ulcer area; and UCI < 0 indicates an increase in ulcer area. For statistical analysis, measurements will be performed at three time points: before treatment, 15 days, and 30 days after the start of treatment. As an alternative method for calculating ulcer area, at these same time points, the ulcers will also be photographed from a distance of 10 cm using a smartphone equipped with a digital area measurement application (ImageJ);For the outcome of ulcer severity classification score, the numerical score (initial-final) from the SIMBAD scale for classifying the severity of foot ulcers in diabetic patients, developed by the IWGF, will be compared. The Diabetic Foot Ulcer Classification System (SINBAD) encompasses six evaluation domains for the lesions, with each domain scored from zero to one. Thus, the closer the final score is to six, the lower the probability of ulcer healing. This scale will be applied before and after the treatments performed in the three study groups;For the outcome of infection severity classification score (initial-final), the guideline from the Infectious Diseases Society of America (IDSA) and the International Working Group on the Diabetic Foot (IWGDF) for classifying the severity of infections in foot ulcers of diabetic patients will be applied. T | — |
Countries
Brazil
Contacts
Public ContactDanielli Piatti
Hospital Universitário do Oeste do Paraná
Outcome results
None listed