Diabetes Mellitus and Diabetic Foot
Conditions
Interventions
Investigational Group I (5 patients): daily home treatment of up to 45 days with the investigative device on the wounds, being phototherapy for 35 min and contact with natural biomembrane latex for 24
Device
E02.774
Sponsors
Faculdade do Gama
Universidade de Brasilia
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients intellectually fit, with diabetes mellitus and affected by foot ulcers of neuropathic origin. With or without clinical signs of infection and after completing and signing a consent form
Exclusion criteria
Exclusion criteria: Pregnant women; under 18 years or over 75 years of age; with history of alcohol or drug abuse; with symptoms and diagnoses of osteomyelitis, local tissue necrosis; with cognitive, neurological, or latex hypersensitivity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of ulcer recovery through the measurement of initial and final area of the ulcer (square centimeters). An average healing process index of 76.9% was observed in Group I, in the Group II control group, mean value was 51.4%, and in the Group III group, with a mean healing process index of 80 % | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the quality of life and impact of the wound in the daily life of the patient through the parameters of limitation by physical aspects and limitation by emotional aspects. Functional capacity loss (67.7%), social impairment (66.6%), overall limitation (60%) and pain (53.4%) Pain evaluation according to McGill's descriptors: throbbing (40%); heat / burn (26.7%); painful and heavy (33%) | — |
Countries
Brazil
Contacts
Public ContactSuelia Rosa
Faculdade do Gama
Outcome results
None listed