Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000370303
Ethics application status
Approved
Date submitted
16/07/2008
Date registered
31/07/2008
Date last updated
31/07/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Plantar Pressure Distribution Patterns during Gait in Diabetic Neuropathy Patients with a History of Foot Ulcer
Scientific title
Plantar pressure distribution patterns during gait in diabetic neuropathy patients with a history of foot ulcer compared to normal subjects
Secondary ID [1] 648 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetic neuropathy 3421 0
Condition category
Condition code
Metabolic and Endocrine 3618 3618 0 0
Diabetes
Neurological 3636 3636 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The subjects involved on this research have their gait analyzed in a Laboratory of Biomechanics and they preform a natural gait wearing sensored insoles which register the plantar pressure distribution during walking in a 10mt flat walkway. The subjects will undergo 1 session in which they will walk the 10 metre walkway twice. There is not a repeated session. the data collection has last in average 30 minutes. During this time, the apparatus are calibrated, positioned on the subjects, there is a time to allow each subject to get used to the equipement and also to the laboratory and finally, time to perform the trials. the subjects perform the gait wearing the Pedar insoles from the fabricant NOVEL (Germany). As there is no intervention, the subjects are called just once to participate of this study.
Intervention code [1] 3151 0
Behaviour
Comparator / control treatment
Normal subjects with no neurological either muskolesqueletal disease are part of the control group and have their gait compared with the studied group.
Control group
Active

Outcomes
Primary outcome [1] 4477 0
plantar pressure distribution measured by sensored insoles
Timepoint [1] 4477 0
The outcome is measured just once by the time of the first visit to the laboratory of Biomechanics
Primary outcome [2] 4510 0
peak pressure at five areas under the foot: rear foot, midfoot, lateral and medial forefoot and hallux. The outcome will be measured by sensored insoles, Pedar system, Novel.
Timepoint [2] 4510 0
one analysis of the plantar pressure in subjects which have a history of plantar ulcer already healed on the last 2 years.
Primary outcome [3] 4511 0
plantar pressure integral at five areas under the foot: rear foot, midfoot, lateral and medial forefoot and hallux. The outcome will be measured by sensored insoles, Pedar system, Novel.
Timepoint [3] 4511 0
one analysis of the plantar pressure in subjects which have a history of plantar ulcer already healed on the last 2 years.
Secondary outcome [1] 7667 0
plantar sensitivity at five areas under the foot: rear foot, midfoot, lateral and medial forefoot and hallux. It will be measured with the monofilaments Sorry-Bauru.
Timepoint [1] 7667 0
one analysis in subjects which have a history of plantar ulcer already healed on the last 2 years.

Eligibility
Key inclusion criteria
The inclusion criteria for both neuropathic groups were: Diabetes Type 1 or 2 with more than five years since onset, and a score higher than six on the Michigan Neuropathy Screening Instrument questionnaire (MNSI-q) for symptoms related to the diabetic neuropathy (Feldman et al., 1994). Additionally, subjects were required to have a minimum of two areas where they did not recognize or feel the touch of a 10-g monofilament during tactile perception testing (Frykberg et al., 1998). For inclusion in the neuropathic group with previous ulceration on the plantar surface, the patients were required to present a history of a foot ulceration within the last year that at the time of the evaluation was healed.
Minimum age
39 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects were excluded if they were over 65 years of age; presented hallux amputation or partial amputation of the foot, except toes; major foot shape alterations by visual inspection, orthopedic disorders of the lower limbs; pain during the data acquisition; used any assistive devices for walking (walking sticks/canes); presented traumatic ulceration that could be immediately recognized by the subject; Charcot arthropathy had been confirmed by radiography, or had foot ulcers at the moment of the evaluation.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/06/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 1043 0
Brazil
State/province [1] 1043 0
SP
Country [2] 1044 0
Brazil
State/province [2] 1044 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 3607 0
University
Name [1] 3607 0
University of Sao Paulo
Country [1] 3607 0
Brazil
Primary sponsor type
Charities/Societies/Foundations
Name
FAPESP - Fundacao de amparo a Pesquisa do Estado de Sao Paulo
Address
R. Pio XI, 1500 - Alto da Lapa - CEP 05468-901 - São Paulo/SP - Brasil
Country
Brazil
Secondary sponsor category [1] 3285 0
None
Name [1] 3285 0
Address [1] 3285 0
Country [1] 3285 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5654 0
CAPPesq - Comite de Etica em pesquisa do Hospital das Clinicas de Sao Paulo
Ethics committee address [1] 5654 0
Av. Dr. Eneas de Carvalho Aguiar, 255 - Cerqueira Cesar - 05403-000 / Sao Paulo - Brasil
Ethics committee country [1] 5654 0
Brazil
Date submitted for ethics approval [1] 5654 0
Approval date [1] 5654 0
19/05/2004
Ethics approval number [1] 5654 0
HC45768-3

Summary
Brief summary
This study is based on the assumption that the presence of foot ulcers in the clinical history of a diabetic subject is a sign of worsening neuropathy, because developing ulceration has been considered the probable result of progressive neurological, vascular and autonomic damage that denote the advancement of the disease over time. For this reason, the purpose of this study was to investigate and compare the influence of the progression of diabetic neuropathy and a previous history of foot ulcers on plantar pressure variables during gait. We hypothesized that, even with healed ulcers, diabetic neuropathy patients with history of ulceration would still show an altered distribution pattern of plantar pressure during gait when compared to patients who had not yet developed ulceration.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28761 0
Address 28761 0
Country 28761 0
Phone 28761 0
Fax 28761 0
Email 28761 0
Contact person for public queries
Name 11918 0
Tatiana Bacarin
Address 11918 0
Universidade de São Paulo, R. Cipotânia, 51, Cidade Universitária – São Paulo – SP, Brazil, 05360-160
Country 11918 0
Brazil
Phone 11918 0
(55 11) 3091-8426
Fax 11918 0
Email 11918 0
[email protected]
Contact person for scientific queries
Name 2846 0
Isabel de Camargo Neves Sacco
Address 2846 0
Universidade de São Paulo, R. Cipotânia, 51, Cidade Universitária – São Paulo – SP, Brazil, 05360-160
Country 2846 0
Brazil
Phone 2846 0
(55 11) 3091-8426
Fax 2846 0
(55 11) 3091-7462.
Email 2846 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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