Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000142730
Ethics application status
Approved
Date submitted
5/02/2013
Date registered
6/02/2013
Date last updated
18/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Arginine supplementation need to be part of routine clinical education for Diabetes Educators in the management of foot ulcers
Scientific title
L-Arginine supplemented diet in Type 2 Diabetes (T2DM) adult clients attending community health services in Townsville: does it improve healing in diabetic foot ulcers?
Secondary ID [1] 281849 0
Nil Known
Universal Trial Number (UTN)
Nil Known
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 288210 0
Diabetic Foot Ulcers 288211 0
Condition category
Condition code
Diet and Nutrition 288577 288577 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 288655 288655 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 (intervention group) will be provided with 4.5 gms of L-Arginine powder per day for 12 weeks orally. The powder can be mixed with water
Intervention code [1] 286408 0
Treatment: Other
Comparator / control treatment
Arm 2 (Comparator group) will be given placebo 4.5 gms per day for 12 weeks orally. The placebo will be identical in appearance to L-Arginine without the active ingredient
Control group
Placebo

Outcomes
Primary outcome [1] 288794 0
Foot ulcer healing rate measurement using UTWCS (University of Texas Wound Classification System) tool
Timepoint [1] 288794 0
At the start (week 1), every occasion of podiatric care and at 12 weeks as part of the study and the clients existing treatment
Secondary outcome [1] 301003 0
Foot Health status questionnaire
Timepoint [1] 301003 0
At the start (week 1) and 12 weeks
Secondary outcome [2] 301004 0
SF-26 questionnaire for QOL (Quality of Life)
Timepoint [2] 301004 0
To be assessed at week 1 and week 12
Secondary outcome [3] 301005 0
Nutrition status using food frequency questionnaire
Timepoint [3] 301005 0
Week 1, 6 and 12
Secondary outcome [4] 301006 0
Blood glucose monitoring for diabetes management
Timepoint [4] 301006 0
Week 1, and every second week for blood glucose and
Week 1 and 12 for HbA1c

Eligibility
Key inclusion criteria
Free living clients over the age of 18 yrs, attending the Townsville Community Health Services
Clients with Type 2 Diabetes
Clients with diabetic foot ulcers
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clients under the age of 18 Pregnant women Clients with food allergies and intolerances Clients who are on Renal Dialysis Clients who have had a fracture, within 3 months of the start of the trial Clients who have been diagnosed with cirrhosis of the liver had burns to 10% or more of his/her body, within 6 months of the start of the trial. Clients who have suffered a heart attack, within 3 months of the start of the trial. Clients who have been scheduled for surgery within two weeks of the start of the trial or during the trial Clients who have low blood pressure. Women who are pregnant and/or breast feeding

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All clients who fit the selection criteria will be invited to participate, and if willing will be provided information on the study and participant consent will be obtained and then enrolled for the study.
Once enrolled in the study they will be randomly allocated to one of the 2 groups, based on a random number table by a clinical nurse/admin who is not involved in the study.
As it is a double blind placebo controlled RCT both clinicians and participants will not be aware of the allocation or the group into which they have been grouped
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Based on a random number table in numerical order of enrollment
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SPSS software will be used

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/12/2018
Actual
Date of last participant enrolment
Anticipated
28/02/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 6246 0
4817 - Kirwan

Funding & Sponsors
Funding source category [1] 286681 0
Charities/Societies/Foundations
Name [1] 286681 0
Australian Diabetes Educators Association
Country [1] 286681 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Diabetes Educators Association
Address
Post: PO Box 163
Woden ACT 2606
Country
Australia
Secondary sponsor category [1] 285455 0
Hospital
Name [1] 285455 0
Queensland Health
Address [1] 285455 0
Townsville Hospital and Health Services
Townsville Community Health Services
138, Thuringowa Drive
Kirwan
QLD 4817
Country [1] 285455 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288749 0
Townsville Hospital Human Research and Ethics Committee
Ethics committee address [1] 288749 0
100, Angus Smith Drive
Douglas
Townsville
QLD 4814
Ethics committee country [1] 288749 0
Australia
Date submitted for ethics approval [1] 288749 0
18/02/2013
Approval date [1] 288749 0
04/03/2013
Ethics approval number [1] 288749 0

Summary
Brief summary
Diabetes is a multi-factorial disease, with a multi-disciplinary approach being advocated for diabetes treatment and the prevention of its complications. In Australia, diabetes is the most common cause of lower limb amputation after trauma. Diabetic foot ulcers are responsible for a substantial medical and financial burden on the Australian healthcare system with costs conservatively estimated to be as high as $45,000 per patient. Improved nutritional status and nutrition supplementation accelerate wound healing while inadequate nutrition prolongs wound healing. During wound healing non-essential amino acids, such as L-Arginine, becomes essential as it enhances a number of pathways involved in wound healing, protein metabolism, such as structural protein synthesis and collagen. Aim: To determine whether supplementation with L-Arginine will improve the healing of diabetic foot ulcers in a routine community based client education and management program conducted by medical and allied health professionals. Methods: This study is being designed as a double blinded RCT (treatment group: n=37+7, 4.5g L-arginine; control group n=19+7 placebo) for 12 weeks. Power calculations indicate 70 patients are required to provide adequate statistical power including anticipated attrition rate. The study will be conducted in a routine community based client education and management setting which includes health professionals (medical, podiatry, dietetic, diabetes educators) as part of a multi-disciplinary approach and holistic care for the client
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37378 0
Mrs Achamma Joseph
Address 37378 0
Senior Dietitian Diabetes and Indigenous Health
Townsville Community Health Services
138, Thuringowa Drive
Kirwan
Townsville
QLD 4817
Country 37378 0
Australia
Phone 37378 0
0061437330442
Fax 37378 0
Email 37378 0
[email protected]
Contact person for public queries
Name 37379 0
Mrs Achamma Joseph
Address 37379 0
Senior Dietitian Diabetes and Indigenous Health
Townsville Community Health Services
138, Thuringowa Drive
Kirwan
Townsville
QLD 4817
Country 37379 0
Australia
Phone 37379 0
0061437330442
Fax 37379 0
Email 37379 0
[email protected]
Contact person for scientific queries
Name 37380 0
Mrs Achamma Joseph
Address 37380 0
Senior Dietitian Diabetes and Indigenous Health
Townsville Community Health Services
138, Thuringowa Drive
Kirwan
Townsville
QLD 4817
Country 37380 0
Australia
Phone 37380 0
0061437330442
Fax 37380 0
Email 37380 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.