Evaluation of Therapeutic Footwear on the foot of people with Diabetes Mellitus
- Conditions
- Diabetes Mellitusdiabetic polyneuropathyC23.550.291.500
- Registration Number
- RBR-3z667w2
- Lead Sponsor
- niversidade Federal de São Paulo - Escola paulista de Enfermagem
- Brief Summary
Introduction: Diabetic peripheral neuropathy is a highly prevalent chronic condition that substantially affects people with Diabetes Mellitus. It is characterized by a diffuse, symmetrical, distal and progressive lesion of the sensory-motor and autonomic fibers, caused by chronic hyperglycemia, which causes a gradual loss of the protective sensation of the feet, increasing the risk of plantar changes, trauma, osteoarticular deformities, biomechanical and balance alterations. Appropriate interventions to prevent complications such as ulcers and amputations have been proposed, among them the use of personalized insole. Objectives: To identify dermatological, bone, sensory and biomechanical changes, and to evaluate the effect of personalized insole on plantar pressure, balance and foot health in Diabetic peripheral neuropathy people due to Type 2 Diabetes Mellitus. Method: Research carried out after ethical approval, cross-sectional and quasi-experimental in people diagnosed with type 2 Diabetes Mellitus and diabetic peripheral neuropathy enrolled in the public primary care network of a city in the east of São Paulo. For the cross-sectional study, signs of biomechanical, dermatological, sensory, bone and balance alterations were evaluated using the Berg Balance Scale instrument. Plantar pressure was identified by baropodometry with the BaroScan® platform. The quasi-experimental study, of the before and after type, was conducted with 45 people who presented changes in plantar pressure identified among the individuals treated at Basic Health Units. The intervention variable corresponded to the use of individualized and personalized insoles, made from the results obtained with baropodometry. The outcome variables were verified three months after the implementation of the intervention, namely: assessment of foot health, balance and plantar pressure. The data obtained were analyzed according to descriptive and inferential statistics, through measures of summary and central tendency, confidence interval, chi-square test, Student's t test, Fisher's exact test and Mann Whitney, adopting as a level of significance 5%. Results: In the cross-sectional study, 200 people were identified; changes in plantar pressure, absence of plantar protective sensation (p=0.029), of the Achilles reflex (p=0.016), decreased vibratory sensitivity (p=0.048) and absent (p=0.009), presence of calluses on the right foot ( p=0.006) and left (p=0.001), hallux valgus in the right foot (p=0.002) and left foot (p=0.002). In baropodometry, the dynamic assessment the mean on the right foot was 6.08 (±2) kgf/cm2 and 6.7 (±1.62) kgf/cm2 on the left foot, the center of static pressure on the right foot was lower ( 10.55±3.82) than in the left foot (11.97±3.90), indicating plantar hyperpressure. The risk of falling was high, ranging from 8 to 56 points, with a mean of 40.96(±10.77) on the Berg Balance Scale. In the quasi-experimental study, after using the customized insole for a period of three months, it was possible to observe a statistically significant reduction in dynamic plantar pressure in the left and right foot (p<0.001) and in static plantar pressure in the right foot (p=0.008 ) of the individuals investigated. There was a significant increase in the average scores of the Foot Status Health Questionnare, in all domains, indicating a significant improvement in the general health of the feet (p<0.001). Conclusion: Dermatological, bone and sensory changes in the feet are related to changes in plantar pressure that can lead to loss of balance and complications in people with diabetic peripheral neuropathy. The use of an insole made from the analysis of areas of plantar hyperpressure reduced plantar pressure and improved the general health of the feet of a group of people with diabetic peripheral neuropathy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruitment completed
- Sex
- Not specified
- Target Recruitment
- Not specified
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)
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
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary outcomes are not expected