Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000693224
Ethics application status
Approved
Date submitted
31/07/2009
Date registered
12/08/2009
Date last updated
12/08/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of a neuropathic ulcers prevention program for people with Diabetes
Scientific title
Evaluation of a neuropathic ulcers prevention program for patients with Diabetes - a randomized controled trial, two years follow up
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic neuropathy 243419 0
Condition category
Condition code
Neurological 239728 239728 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 237053 0
Prevention
Comparator / control treatment
Non sistematic therapeutic education: Brief and general patient instructions for the care of foot were provided during the individual follow up examinations (three-months intervals reevaluations).
Control group
Active

Outcomes
Primary outcome [1] 240485 0
neuropathic ulcers: number of incidence and relapses of ulceration (detected during foot examination and interview of the patient in the three-months intervals reevaluations)
Timepoint [1] 240485 0
at the end of 2 years follow up
Secondary outcome [1] 257032 0
survival time without any ulcers (no incidence and relapses of ulceration detected during foot examination and interview of the patient in the three-months intervals reevaluations)
Timepoint [1] 257032 0
at the end of 2 years follow up (three-months intervals reevaluations)

Eligibility
Key inclusion criteria
People with diabetic insensitive foot in risk to ulceration
Minimum age
50 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neuropathy from other causes, diabetic patients without medical assistance

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruitment at a general diabetes clinic, evaluation, random allocation between intervention or control group. The examiner was unaware when the decision of allocation was done. Allocation envolved an off-site person of the research team who used a randomized table created by a computer software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 1929 0
Brazil
State/province [1] 1929 0
Country [2] 1930 0
Brazil
State/province [2] 1930 0
Rio Grande do Sul/ Porto Alegre

Funding & Sponsors
Funding source category [1] 237425 0
University
Name [1] 237425 0
UNIVERSIDADE FEDERAL DE MINAS GERAIS
Country [1] 237425 0
Brazil
Primary sponsor type
University
Name
LIGIA DE LOIOLA CISNEROS
Address
Departamento de Fisioterapia EEFFTO
Av. Antonio Carlos, 6627 - Pampulha - Belo Horizonte - MG
Postcode 31270-901
Country
Brazil
Secondary sponsor category [1] 236919 0
University
Name [1] 236919 0
Pro Reitoria de Pos Graduacao - UFMG
Address [1] 236919 0
Av. Antonio Carlos, 6627 - Pampulha - Belo Horizonte - MG
Postcode 31270-901
Country [1] 236919 0
Brazil
Other collaborator category [1] 802 0
University
Name [1] 802 0
Universidade Federal de Minas Gerais - Faculdade de Educacao - Prof Luiz Alberto Oliveira Gon?alves
Address [1] 802 0
Av. Antonio Carlos, 6627 - Pampulha - Belo Horizonte - MG
Postcode 31270-901
Country [1] 802 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239556 0
Secretaria Municipal de Saude de Porto Alegre/RS
Ethics committee address [1] 239556 0
Av. Joao Pessoa, 325 - Porto Alegre/RS Postcode 90040-000
Ethics committee country [1] 239556 0
Brazil
Date submitted for ethics approval [1] 239556 0
17/09/2000
Approval date [1] 239556 0
25/10/2000
Ethics approval number [1] 239556 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29994 0
Address 29994 0
Country 29994 0
Phone 29994 0
Fax 29994 0
Email 29994 0
Contact person for public queries
Name 13241 0
Ligia de Loiola Cisneros
Address 13241 0
Rua Artur Itabirano 239/601 Pampulha Belo Horizonte Minas Gerais
Postcode 31275-020
Country 13241 0
Brazil
Phone 13241 0
55 (31) 34031611
Fax 13241 0
Email 13241 0
[email protected]
Contact person for scientific queries
Name 4169 0
Ligia de Loiola Cisneros
Address 4169 0
Av Antonio Carlos 6627 - Pampulha
EEFFTO - Depto de Fisioterapia
Postcode 31270-901
Country 4169 0
Brazil
Phone 4169 0
55 (31) 34094783
Fax 4169 0
55 (31) 34094783
Email 4169 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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