Diabetic Foot
Conditions
Interventions
This is a two-arm, non-blind, randomized controlled clinical trial. A total of 50 people who meet the eligibility criteria will be probabilistically allocated to one or the other intervention group us
Sponsors
Universidade Federal Fluminense
Hospital Universitário Antônio Pedro
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Be over 18 years of age, regardless of gender; have a chronic wound larger than 2 cm² and smaller than 100 cm²; have a wound that has been present for more than 12 weeks; have a wound without signs of infection (PEDIS 1 or NERDS/STONES negative); and be available to attend the outpatient clinic weekly.
Exclusion criteria
Exclusion criteria: Pregnant and breastfeeding women; Undergoing immunosuppressive and/or antimicrobial therapies; Suspected or confirmed oncological disease associated with the wound; Suspected or confirmed wound infection; People with visual and/or hearing impairments or who do not have full autonomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| An increase in the rate of wound healing is expected over the follow-up period, verified by measuring the area of ??the ulcers in square centimeters, based on the finding of a 100% reduction in the initial area associated with complete epithelialization of the lesion.;A reduction in wound area is expected throughout the follow-up period, verified by measurement in square centimeters, based on a percentage reduction greater than 50% between the pre- and post-intervention periods. | — |
Secondary
| Measure | Time frame |
|---|---|
| A reduction in the microbial load in the lesions is expected over the follow-up period, verified by quantifying colony-forming units, based on the observation of a decrease in the microbial load between the evaluated periods.;Patient satisfaction with the therapy used is expected to increase over the follow-up period, as verified by a Likert-type scale, based on responses classified as "excellent" or "good".;An improvement in the quality of life of participants is expected throughout the follow-up period, verified through an ordinal Likert-type scale, based on responses classified as "excellent" or "good".;A reduction in the average total monthly cost related to treatment is expected over the follow-up period, verified through measurement in reais (Brazilian currency), based on a comparison between the average cost of the intervention group and the control group. | — |
Countries
BR
Contacts
Public ContactBeatriz de Oliveira
Universidade Federal Fluminense
Outcome results
None listed