Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000761066
Ethics application status
Approved
Date submitted
7/09/2010
Date registered
14/09/2010
Date last updated
14/09/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Obesity and worsening of chronic venous disease and joint mobility
Scientific title
An investigation of the possible relationship between obesity and decreased mobility of the talocrural joint and chronic venous disease as assessed using goniometry and the CEAP classification of venous disease.
Secondary ID [1] 252647 0
no have secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic venous disease 258143 0
Obesity 258169 0
Condition category
Condition code
Cardiovascular 258320 258320 0 0
Diseases of the vasculature and circulation including the lymphatic system
Diet and Nutrition 258351 258351 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is investigate a possible relationship between obesity and decreased mobility of the talocrural joint and chronic venous disease. Will be evaluated 100 patient's transversal and quanti tative. The recruitment and assessments are the order arrival at hospital. Patients will be classified according to CEAP (Clinical, etiology, anatomy, pathophysiology), where: C0 are patients without venous insufficiency (no varices); C1 telangiectasia (microvarices) C2 with varicose veins, varicose veins and edema with C3, C4 with trophic changes, ulcers healed with C5 and C6 with open sore. Evaluation will be conducted by CEAP with clinic examination and goniometry talocrural for the degree of mobility of the limb. The approximate duration of tests per patient will 30 minutes, clinical examination for CEAP classification with duration of 15 minutes and goniometry approximately 15 minutes in a single session .
Intervention code [1] 257156 0
Diagnosis / Prognosis
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259173 0
Relationship between obesity Body Index Mass >30 (BMI) and decreased mobility of the talocrural joint associated chronic venous disease evaluated by goniometry
Timepoint [1] 259173 0
Transversal study
Secondary outcome [1] 265520 0
No have key secondary outcome
Timepoint [1] 265520 0
No have timepoint

Eligibility
Key inclusion criteria
obese patients with body mass index (BMI) > 30.
Minimum age
21 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with infectious conditions that hamper the assessment.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 2855 0
Brazil
State/province [1] 2855 0
Parana

Funding & Sponsors
Funding source category [1] 257612 0
Self funded/Unfunded
Name [1] 257612 0
Country [1] 257612 0
Primary sponsor type
Individual
Name
Cleusa Ema Quilici Belczak
Address
Av. Tiradentes, 1081
Maringa, Parana, Brazil
CEP 87013-260
Country
Brazil
Secondary sponsor category [1] 256834 0
None
Name [1] 256834 0
Address [1] 256834 0
Country [1] 256834 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259631 0
Centro Universitario de Maringa-CESUMAR-Brazil
Ethics committee address [1] 259631 0
AV Guedner, 1610-Maringa Parana-Brazil
Zipe code: 87050-390
Ethics committee country [1] 259631 0
Date submitted for ethics approval [1] 259631 0
Approval date [1] 259631 0
02/07/2009
Ethics approval number [1] 259631 0
240-2009

Summary
Brief summary
The aim of this study is investigate a possible relationship between obesity and decreased mobility of the talocrural joint and chronic venous disease. Will be evaluated in order of arrival at hospital, 100 patients transversal and quantitative. Patients will be classified according to CEAP, where: C0 are patients without venous insufficiency (no varices); C1 telangiectasia (microvarices) C2 with varicose veins, varicose veins and edema with C3, C4 with trophic changes, ulcers healed with C5 and C6 with open sore. Evaluation will be conducted by goniometry talocrural for the degree of mobility of the limb. For statistical analysis Normality Test Kolmogorov-Smirnov, Kruskal-Wallis test, Dunn's Multiple Comparison Test, analysis of variance, an alpha error of 5%. The hypothesis of the study is the relation of obesity with decreased joint mobility of the talocrural joint.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31615 0
Address 31615 0
Country 31615 0
Phone 31615 0
Fax 31615 0
Email 31615 0
Contact person for public queries
Name 14862 0
Jose Maria Pereira de Godoy
Address 14862 0
Av Constituicao 1306-Sao Jose do Rio Preto-Sao Paulo-Brazil
Zipe code: 15025-120
Country 14862 0
Brazil
Phone 14862 0
55 17 81556660
Fax 14862 0
Email 14862 0
[email protected]
Contact person for scientific queries
Name 5790 0
Cleusa Ema Quilici Belczak
Address 5790 0
Av. Tiradentes, 1081

Maringa, Parana, Brazil
CEP 87013-260
Country 5790 0
Brazil
Phone 5790 0
55 44 99176777
Fax 5790 0
Email 5790 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
No additional documents have been identified.