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Trial registered on ANZCTR


Registration number
ACTRN12612000036819
Ethics application status
Approved
Date submitted
9/01/2012
Date registered
9/01/2012
Date last updated
9/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Nutritional Supplementation on the Healing of Diabetic Foot Ulcers
Scientific title
A randomised-controlled trial of oral arginine supplementation on the healing of foot ulcers in patients with type 2 diabetes
Secondary ID [1] 279681 0
Nil
Universal Trial Number (UTN)
U1111-1126-9210
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic foot ulcers 285507 0
Condition category
Condition code
Skin 285698 285698 0 0
Other skin conditions
Metabolic and Endocrine 285705 285705 0 0
Diabetes
Alternative and Complementary Medicine 285706 285706 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will consume daily two sachets of a commercial arginine powder (Arginaid [Registered Trademark]; Nestle Medical Nutrition) giving a final dose (from the two sachets combined) of 9 grams of arginine, 310 mg of vitamin C, and 180 IU (81 mg) of vitamin E in total for a 4-week week period on top of their normal diet.

At baseline, and at weeks 2 and 4 corresponding to outpatient clinic visits, patients will have measurements of the foot ulcer size and depth taken as well as their overall health status to assess the rate of healing over 6 weeks. Non-nutrition foot ulcer care will be kept constant during the study period according to standard clinic protocols.
Intervention code [1] 283971 0
Treatment: Other
Comparator / control treatment
The control group will consume their normal diet. Both groups will receive standard dietetic intervention independent to which group they are allocated in accordance to normal nutritional assessment and interventions that occur as a routine part of a patient's attendance at the outpatient service.
Control group
Active

Outcomes
Primary outcome [1] 286227 0
Healing rate of the foot ulcer is the primary outcome measure of the study. Wounds will be measured using the IWGDF PEDIS system. The system classifies foot ulcers according to five categories: perfusion, extent/size, depth/tissue loss, infection and sensation and changes in these parameters over time will allow a quantitative measure of wound healing.
Timepoint [1] 286227 0
Baseline, week 2 and 4
Secondary outcome [1] 295414 0
Quality of Life (QoL) will be assessed using the Short Form-36 (SF-36) questionnaire
Timepoint [1] 295414 0
Baseline and week 4
Secondary outcome [2] 295415 0
Nutrition assessment by subjective global assessment (SGA)
Timepoint [2] 295415 0
Baseline
Secondary outcome [3] 295416 0
Information about dietary intake will be obtained using the multiple-pass 24-hour food recall method.
Timepoint [3] 295416 0
Baseline, week 2 and 4

Eligibility
Key inclusion criteria
Study eligibility will include a confirmed diagnosis of Type 2 diabetes mellitus and a foot ulcer with an International Working Group of the Diabetic Foot (IWGDF) PEDIS classifications (as listed below) of at least 4 weeks duration.
1. Perfusion: Grades 1-3
2. Depth: Grades 1-3
3. Infection: Grades 1-3
4. Sensation: Grades 1 and 2
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a Grade 4 infection rating according to the IWGDF PEDIS classification system will be excluded as systemic signs will usually require hospital admission. Patients with phenylketonuria, sepsis, chronic renal failure, malignancy, and chronic inflammatory bowel disease, will be excluded for health and safety reasons. Individuals receiving hydroxyurea or greater than 10 mg prednisolone or 1.5 mg dexamethasone per day will also be excluded as these drugs can impact on the rate of healing of diabetic foot ulcers. Individuals using insulin to manage their diabetes will also be excluded.

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)
Patients will be recruited through the High Risk Foot Service Clinic at Northern Health and randomised to either the control group or intervention group. All patients eligible to participate in the study will have the procedures, risks and inconveniences explained to them and will be asked to provide informed consent either in writing or verbal (for patients unable to write).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised into the intervention or control group by order of enrolment which will occur by block randomisation. The order of the block allocation sequence will be determined before the beginning of the study by sorting a list of random numbers generated by a computer program, assigned to each of the randomisation blocks in numerical order and using sequences as the allocation order of the study. The randomisation procedure will be performed by a member of the research team located off-site and not directly involved in participant recruitment. As each patient is enrolled, they will advise the research team of the treatment allocation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284465 0
Self funded/Unfunded
Name [1] 284465 0
Address [1] 284465 0
Country [1] 284465 0
Primary sponsor type
Hospital
Name
Northern Hospital
Address
185 Cooper St
Epping VIC 3076
Country
Australia
Secondary sponsor category [1] 283391 0
University
Name [1] 283391 0
Deakin University
Address [1] 283391 0
School of Exercise and Nutrition Science
Burwood Hwy
Burwood VIC 3125
Country [1] 283391 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286445 0
Northern Health Human Research Ethics Committee
Ethics committee address [1] 286445 0
185 Cooper St
Epping VIC 3076
Ethics committee country [1] 286445 0
Australia
Date submitted for ethics approval [1] 286445 0
10/11/2011
Approval date [1] 286445 0
21/12/2011
Ethics approval number [1] 286445 0
P23/11

Summary
Brief summary
Diabetic foot ulcers are a common consequence of diabetes, which occur as a result of the vascular and neurological complications associated with the disease, as well as opportunistic infections and inadequate wound healing. The most recent prevalence estimates suggest that between 4 and 10% of individuals with diabetes have foot ulcers.

Recent clinical research has focussed on the dietary conditionally essential amino acid arginine and its role in wound healing. Published research has shown that it offers a benefit in the healing of pressure ulcers (also known as bed sores). Little in the way of human studies using clinically relevant models examining the effect of arginine supplementation on diabetic foot ulcers have been conducted. If the same rate of diabetic foot ulcer healing can be achieved with arginine supplementation as seen with pressure ulcers, then this would have important management implications in treating this condition.

This project aims to assess by means of a randomised-controlled trial, the healing rate of diabetic foot ulcers in patients with diabetes attending a hospital outpatient clinic who are consuming an arginine-containing nutritional supplement versus patients who are only receiving standard nutritional care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33598 0
Address 33598 0
Country 33598 0
Phone 33598 0
Fax 33598 0
Email 33598 0
Contact person for public queries
Name 16845 0
A/Prof. Tim Crowe
Address 16845 0
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country 16845 0
Australia
Phone 16845 0
+61 3 9251 7266
Fax 16845 0
Email 16845 0
tim.crowe@deakin.edu.au
Contact person for scientific queries
Name 7773 0
A/Prof. Tim Crowe
Address 7773 0
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country 7773 0
Australia
Phone 7773 0
+61 3 9251 7266
Fax 7773 0
Email 7773 0
tim.crowe@deakin.edu.au

No information has been provided regarding IPD availability
Summary results
No Results