Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000419369
Ethics application status
Approved
Date submitted
1/08/2008
Date registered
25/08/2008
Date last updated
25/08/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Arginine and wound healing in patients with critical limb ischaemia recovering from a bypass graft
Scientific title
The effectiveness of an Arginine-enriched diet in patients with critical limb ischaemia. Does it improve post-surgical outcomes?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower-limb ischaemia 3422 0
Condition category
Condition code
Surgery 3576 3576 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Standard hospital diet plus two tetrapaks of a commercially available Arginie-enriched oral nutrition supplement (9g Arginine/day). The intervention will commence on entry to the study and will cease 30 days after the time of the bypass graft
Intervention code [1] 3152 0
Treatment: Other
Comparator / control treatment
Standard hospital diet plus two tetrapaks of a commercially available oral nutrition supplement which is matched in terms of nutritional composition to the intervention except for the Arginine (with the comparator treatment providing <1g arginine/day). The comparator treatment will commence on entry to the study and will cease 30 days after the time of the bypass graft.
Control group
Active

Outcomes
Primary outcome [1] 4479 0
Time to wound healing; measured using a semi-quantitative wound assessment questionnaire developed by an experienced vascular clinical nurse
Timepoint [1] 4479 0
Day 0 (surgery) to day it is determined that wound is healed. Wound assessment will be conducted on a weekly basis throughout this period.
Primary outcome [2] 4480 0
Length of stay
Timepoint [2] 4480 0
Day 0 (surgery) to hospital discharge
Secondary outcome [1] 7570 0
Quality of life measured by the AQoL (Assessment of Quality of Life) tool
Timepoint [1] 7570 0
Baseline (entrance to the study), 30 days, 3 months, and 6 months post-surgery
Secondary outcome [2] 7571 0
Change in nutritional health as determined by change in weight, Body Mass Index (BMI), corrected arm muscle area (CAMA) and nutritional intake
Timepoint [2] 7571 0
Baseline and at 3 day intervals until discharge from hospital

Eligibility
Key inclusion criteria
All patients with chronic critical lower-limb ischaemia admitted to the Vascular unit at the Repatriation General Hospital for a bypass graft procedure.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients receiving palliative care and ICU (intensive care unit) patients. Patients who are nil by mouth or who require enteral feeding or parenteral nutrition. Patients who are unable to fulfill the requirements of the study due to impaired cognition

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Research personnel will provide each potential participant with a patient information sheet outlining the study requirements. Patients willing to participate will sign an informed consent document, have all baseline measures performed and then be randomised. Treatment allocation will be sealed in foil lined envelopes by a person external ot the study. The allocation of participants to the trial will be maintained by the Pharmacy dept at the Repatriation General Hospital.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computerised number generator will be used to generate the randomisation sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3608 0
University
Name [1] 3608 0
Flinders University Faculty of Health Sciences
Country [1] 3608 0
Australia
Primary sponsor type
University
Name
Flinders University Faculty of Health Sciences
Address
GPO Box 2100, Adelaide, SA
Country
Australia
Secondary sponsor category [1] 3250 0
None
Name [1] 3250 0
Address [1] 3250 0
Country [1] 3250 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5655 0
Repatriation General Hospital HREC
Ethics committee address [1] 5655 0
Repatriation General Hospital Daws Road Daw Park SA 5041
Ethics committee country [1] 5655 0
Australia
Date submitted for ethics approval [1] 5655 0
Approval date [1] 5655 0
22/07/2008
Ethics approval number [1] 5655 0
26/08

Summary
Brief summary
Patients with critical lower-limb ischaemia admitted to RGH for a bypass graft will be invited to participate in a study investigating the effect of a diet that is enriched with arginine on the time taken for the surgical wound to heal. Participants will be allocated at random to receive either a standard hospital diet with 2 Arginine-enriched supplements or a standard hospital diet with 2 standard nutritional supplements, that are equal in energy, protein, vitamins and minerals. In addition to the time taken for the wound to heal, participants will also have their nutritional health measured via body weight, dietary intake and arm muscle stores. Quality of life will also be measured.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28762 0
Address 28762 0
Country 28762 0
Phone 28762 0
Fax 28762 0
Email 28762 0
Contact person for public queries
Name 11919 0
Dr Michelle Miller
Address 11919 0
Department Nutrition and Dietetics
Flinders University
Block G4
FMC Flats
Flinders Drive
Bedford Park SA 5042
Country 11919 0
Australia
Phone 11919 0
(08) 8204-5328
Fax 11919 0
(08) 8204-6406
Email 11919 0
[email protected]
Contact person for scientific queries
Name 2847 0
Dr Michelle Miller
Address 2847 0
Department Nutrition and Dietetics
Flinders University
Block G4
FMC Flats
Flinders Drive
Bedford Park SA 5042
Country 2847 0
Australia
Phone 2847 0
(08) 8204-5328
Fax 2847 0
(08) 8204-6406
Email 2847 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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