None listed
Conditions
Brief summary
53 patients from a public health center in Porto Alegre/RS, with diabetes and neuropathy, were enrolled in a clinical trial and followed up for two years. Subjects were randomly allocated in either intervention or control group. Therapeutic education was provided in group sessions, and a protective footwear supplied according to individual prescriptions. Statistical analysis using Mann-Whitney non-parametrical test was performed to determine differences in incidence and relapses of ulceration between groups. An analysis of life table and Kaplan-Meier method were used to measure survival time without any ulcers.
Interventions
Therapeutic education and protective footwear. Education class was given by the examiner on 4 group sessions of one hour, once a week for a total of 4 weeks. Special games were used as a teaching tool. During the individual follow up examination (three-months intervals reevaluations), instruction for foot care were reinforced. The protective footwear was supplied according to individual prescriptions to be worn daily for, at least, 6 hours. Two pairs were supplied during the 2 years follow up.
Sponsors
LIGIA DE LOIOLA CISNEROS
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
People with diabetic insensitive foot in risk to ulceration
Exclusion criteria
Neuropathy from other causes, diabetic patients without medical assistance
Outcome results
None listed