Trial registered on ANZCTR


Trial ID
ACTRN12610000792022
Ethics application status
Approved
Date submitted
16/09/2010
Date registered
24/09/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prevalence of Concurrent Deep Vein Thrombosis in Patients with Lower Limb Cellultis
Scientific title
Prevalence of Concurrent Deep Vein Thrombosis in Patients with Lower Limb Cellultis
Secondary ID [1] 252712 0
None
Universal Trial Number (UTN)
U1111-1111-0324
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cellulitis of the lower limb 251938 0
Deep vein thrombosis 251939 0
Condition category
Condition code
Infection 252121 252121 0 0
Other infectious diseases
Blood 252122 252122 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients with lower limb cellulitis will be investigated for concurrent deep venous thrombosis. This will be through application of the Wells score, which is a clinical assessment tool for assessing the probability of deep vein thrombosis, a D-dimer blood test and if neccessary an ultrasound scan of the deep venous system. This will occur once at recruitment.
Intervention code [1] 241357 0
Diagnosis / Prognosis
Comparator / control treatment
nil.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253002 0
Prevalence of concurrent deep venous thrombosis in patients with cellulitis of the lower limb
Timepoint [1] 253002 0
At time of diagnosis
Secondary outcome [1] 257774 0
Predictive value of the Wells score in this population. The Wells score is a clinical assessment tool for assessing the probability of deep vein thrombosis.
Timepoint [1] 257774 0
At time of diagnosis

Eligibility
Key inclusion criteria
Patients admitted to Christchurch Hospital with lower limb cellulitis
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
nil

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)
All patients admitted with lower limb cellulitis will be approached by a member of the clinical team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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)
Efficacy

Recruitment
Anticipated date of first participant enrolment
1/07/2010
Actual date of first participant enrolment
Anticipated date last participant enrolled
Actual date last participant enrolled
Anticipated date of last data collection
Actual date of last data collection
Target sample size
200
Actual sample size
Recruitment status
Completed
Recruitment outside Australia
Country [1] 2161 0
New Zealand
State/province [1] 2161 0
Canterbury

Funding & Sponsors
Funding source category [1] 243818 0
Hospital
Name [1] 243818 0
Canterbury District Health Board
Address [1] 243818 0
Christchurch Hospital
Riccarton Ave
Private Bag 4710
Christchurch
8011
Country [1] 243818 0
New Zealand
Primary sponsor type
Hospital
Name
Canterbury District Health Board
Address
Christchurch Hospital
Riccarton Ave
Private Bag 4710
Christchurch
8011
Country
New Zealand
Secondary sponsor category [1] 237167 0
None
Name [1] 237167 0
Address [1] 237167 0
Country [1] 237167 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243947 0
Upper South Regional Ethics Committee (NZ)
Ethics committee address [1] 243947 0
C/- Ministry of Health
4th floor
250 Oxford Terrace
PO Box 3877
Christchurch
8011
Ethics committee country [1] 243947 0
New Zealand
Date submitted for ethics approval [1] 243947 0
01/10/2009
Approval date [1] 243947 0
Ethics approval number [1] 243947 0
N/A

Summary
Brief summary
Both lower limb cellulitis and deep vein thrombosis are common conditions that share some clinical features. This often leads to the investigation of possible deep vein thrombosis in patients with cellulitis. The result of a retrospective audit suggested that the rate of deep vein thrombosis in patients is low. This study would assess in a prospective way, the rate of deep venous thrombosis in patients with cellulitis. It would also assess the specificity of the currently used assessment criteria for possible deep vein thrombosis in patients with cellulitis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30341 0
Address 30341 0
Country 30341 0
Phone 30341 0
Fax 30341 0
Email 30341 0
Contact person for public queries
Name 13588 0
Michael Maze
Address 13588 0
Dept. Infectious Diseases
Christchurch Hospital
Riccarton Ave
Private Bag 4710
Christchurch
8011
Country 13588 0
New Zealand
Phone 13588 0
+64 3 3640640
Fax 13588 0
Email 13588 0
Michael.Maze@cdhb.govt.nz
Contact person for scientific queries
Name 4516 0
Michael Maze
Address 4516 0
Dept. Infectious Diseases
Christchurch Hospital
Riccarton Ave
Private Bag 4710
Christchurch
8011
Country 4516 0
New Zealand
Phone 4516 0
+64 3 3640951
Fax 4516 0
+64 3 3640952
Email 4516 0
Michael.Maze@cdhb.govt.nz