Diabetes Mellitus and Diabetic Foot
Conditions
Interventions
Protocol HRG (Hospital Regional de Gama) 60 patients divided into two groups. Control group: 30 patients treated with dressings of alginate or silver foam with change every 5 days and
Experimental gro
Device
E02.774
Sponsors
Faculdade do Gama
Universidade de Brasilia
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients aged between 18 years and 75 years; with history of diabetes mellitus type I or II; to present a single type A1 or A2 diabetic foot ulcer (University of Texas classification, with indication of outpatient treatment, without infection and without indication of surgical debridement, with a history of diabetic foot ulcer of more than 6 weeks duration and less of 12 months, have no allergy to latex, intellectually fit, have a cell phone with the ability to take photographs and have the application WhatsApp
Exclusion criteria
Exclusion criteria: Diabetes mellitus uncontrolled with glycated Hb> 10 g / dl; irregular use of medication for the disease or even without regular medical follow-up; evidence of osteomyelitis or gangrene at either end; have lesions with excessive exudate; be an active smoker, regular user of alcoholic beverages and / or illicit drugs; another chronic disease that at the discretion of the investigator compromises the participation in the study; pregnant or lactating women or women of child-bearing age without adequate contraception; participation in another clinical study in less than 1 year (unless justified by the researcher)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the time required to heal and the response of each wavelength applied in the diabetic foot ulcer with the combined use of biomembrane derived from the natural latex (Hevea brasiliensis) associated to the light emitting equipment of leds and the standard treatment with dressings containing calcium alginate or SUS silver foam | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of wounds that reach closure at the end of 90 days of treatment; percentage reduction of the wound area (cm2) in the treatment groups at the end of 90 days of treatment compared to the baseline; comparison of fibroblast cell proliferation at each dosage of the wavelength ranges from 450 to 636; Comparison of the percentage reduction of wound area for varied wavelength protocol to red protocol (636 nm) - previously studied by the research group (since 2013); evolution of comparative quality of life among the treatments proposed; evaluation of signs and symptoms of adverse events of the proposed treatments; Validation of the image processing protocol developed in comparison to the ImageJTM standard with the data collected; to obtain a mathematical representation of the healing process by means of modeling techniques with the data collected; evaluate the electrical impedance of healed skin by reading the galvanic resistance of the skin (GRS) | — |
Countries
Brazil
Contacts
Public ContactSuelia Rosa
Universidade de Brasilia
Outcome results
None listed