Diabetic Foot
Conditions
Interventions
The 30 research subjects will be divided into one of the two groups (intervention or control) according to randomization and will receive one of the treatments described below.
Treatment group interve
Drug
Sponsors
Faculdade Metropolitana da Grande Fortaleza
Universidade Federal do Ceará
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Previous diagnosis of type 2 diabetes mellitus; Presence of perforated plantar ulcer with an area smaller than 24 cm². In cases of patients with more than one ulcer, the largest diameter will be chosen as the reference ulcer for the evaluation measures; Male or female research subjects aged 18 or over and 65 or under; Able to understand the nature and purpose of the study, including risks and adverse effects and with the intention of cooperating with the researcher and acting in accordance with the requirements of the entire trial.
Exclusion criteria
Exclusion criteria: Those patients who obtain a positive response to any of the following criteria will be excluded from the study will exclude the research subject from the study: Research subject who has known hypersensitivity or related compounds; history of serious adverse reactions; Presence of peripheral obstructive arterial disease; Drug addiction, including alcohol; Infection in the ulcer diagnosed at the time of recruitment or during the development of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to identify the wound healing rate (CT), verified by measuring the percentage of variation of the wound area in relation to the baseline measured at the first consultation. This area will be presented in cm2 and the measurement of the speed of healing / epithelization of the ulcer will be observed until the end of the 90-day period or until complete healing occurs before that period. Statistical analysis will be performed to verify if there was a statistically significant difference between the healing area of both groups, with a 95% confidence level agreed here, and a p ? 0.05 value to consider statistical significance between the two groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to identify as a secondary outcome the proportion of patients who evolved with the complete healing of the ulcer before the end of the follow-up period, verified by the number of days necessary for the total closure of the lesion.;It is expected to assess the pain referred by the patient himself at each follow-up visit, by applying a visual analog scale (VAS) for pain, consisting of faces and numbers ranging from zero to ten, where zero indicates the absence of pain and ten denotes the worst possible pain; verified in Visit 05, Visit 09 and Visit 13, in relation to the baseline value measured in Visit 01 | — |
Countries
Brazil
Contacts
Public ContactLuciana ;Manuela Menezes;Coelho
Faculdade Metropolitana da Grande Fortaleza;Faculdade Metropolitana da Grande Fortaleza
Outcome results
None listed