Diabetes Mellitus
Conditions
Interventions
This is a single-group, open-label clinical trial. The intervention in the present study took place in 247 participants (before and after), through the use of therapeutic footwear with modification of
MT3.575.583.601
Sponsors
Universidade Federal de São Paulo - Escola paulista de Enfermagem
Universidade Federal de São Paulo - Escola paulista de Enfermagem
Eligibility
Inclusion criteria
Inclusion criteria: Individuals with Type 2 Diabetes Mellitus; individuals registered in the municipal public network of São João da Boa Vista-São Paulo; with more than five years of diagnosis; individuals with a previous diagnosis of Peripheral Diabetic Neuropathy; both sexes; age group over 30 years old; individuals who agree to participate in the research and present cognitive conditions (alert individuals, mental capacity to comply with the study requirements voluntarily)
Exclusion criteria
Exclusion criteria: Individuals with cognitive impairment; individuals who stop wearing therapeutic shoes after the intervention begins; pregnancy; active systemic cancer; cervical and lumbar spine diseases; stroke; cerebral palsy; rheumatoid arthritis; lower limb prosthesis; general lower limb surgery; lower limb osteoarthritis; gait instability; charcot disease; plantar hyperkeratosis; neuro-ischemic diabetic foot
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study outcome variable will be composed of the use of therapeutic footwear, where the modification of existing footwear into footwear with an intended therapeutic effect will be carried out, aiming at pressure relief, through the use of the personalized insole according to the need of each individual with risk of developing ulceration 1, 2 and 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected | — |
Countries
Brazil
Contacts
Public ContactJuliana Santos
Universidade Federal de São Paulo
Outcome results
None listed