Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000156381
Ethics application status
Approved
Date submitted
27/03/2008
Date registered
2/04/2008
Date last updated
2/04/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Arginine and wound healing in patients recovering from a lower limb amputation
Scientific title
The effectiveness of an Arginine-enriched diet in patients with a lower-limb amputation. Does it reduce healing time and faciliate earlier prosthetic fitting?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower-limb amputations 2798 0
Condition category
Condition code
Surgery 2934 2934 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 on the day that prosthetic casting occurs.
Intervention code [1] 2539 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
Control group
Active

Outcomes
Primary outcome [1] 3815 0
Time to wound healing.
Timepoint [1] 3815 0
Day 0 (surgery) to day it is determined that wound is healed
Primary outcome [2] 3816 0
Time to prosthetic casting and fitting
Timepoint [2] 3816 0
Day 0 (surgery) to day of casting and fitting
Primary outcome [3] 3817 0
Length of stay
Timepoint [3] 3817 0
Day 0 (surgery) to hospital discharge
Secondary outcome [1] 6432 0
Quality of life measured by the AQoL
Timepoint [1] 6432 0
Baseline (entrance to the study) and discharge
Secondary outcome [2] 6433 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] 6433 0
Baseline and at 3 day intervals until discharge from hospital

Eligibility
Key inclusion criteria
All patients admitted to the Vascular unit at the Repatriation General Hospital for a trans-tibial or trans-femoral amputation.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have not had a rigid removable dressing fitted within 24 hours of surgery. Patients receiving palliative care and ICU 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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2008
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] 3228 0
Charities/Societies/Foundations
Name [1] 3228 0
Foundation Daw Park
Country [1] 3228 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Block G4
Flinders Medical Centre (FMC) Flats
Flinders Drive
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 2890 0
Hospital
Name [1] 2890 0
Repatriation General Hospital
Address [1] 2890 0
Daws Road
Daw Park SA 5041
Country [1] 2890 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5213 0
Repatriation General Hospital HREC
Ethics committee address [1] 5213 0
Repatriation General Hospital
Daws Road
Daw Park SA 5041
Ethics committee country [1] 5213 0
Australia
Date submitted for ethics approval [1] 5213 0
Approval date [1] 5213 0
20/03/2008
Ethics approval number [1] 5213 0
11/08

Summary
Brief summary
Patients admitted to RGH for a lower-limb amputation 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 amputation wound to heal, and the time taken to have a prosthetic limb fitted. 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 28355 0
Address 28355 0
Country 28355 0
Phone 28355 0
Fax 28355 0
Email 28355 0
Contact person for public queries
Name 11512 0
Jolene Thomas
Address 11512 0
Department Nutrition and Dietetics
Flinders University
Block G4
FMC Flats
Flinders Drive
Bedford Park SA 5042
Country 11512 0
Australia
Phone 11512 0
+61 8 82044715
Fax 11512 0
+61 8 82046406
Email 11512 0
jm.thomas@flinders.edu.au
Contact person for scientific queries
Name 2440 0
Jolene Thomas
Address 2440 0
Department Nutrition and Dietetics
Flinders University
Block G4
FMC Flats
Flinders Drive
Bedford Park SA 5042
Country 2440 0
Australia
Phone 2440 0
+61 8 82044715
Fax 2440 0
+61 8 82046406
Email 2440 0
jm.thomas@flinders.edu.au

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
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Documents added automatically
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