ANZCTR - Registration

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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

2/09/2024

Date data sharing statement initially provided

2/09/2024

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]

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

Condition category

Condition code

Skin

Other skin conditions

Metabolic and Endocrine

Diabetes

Alternative and Complementary Medicine

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]

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]

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]

Baseline, week 2 and 4

Secondary outcome [1]

Quality of Life (QoL) will be assessed using the Short Form-36 (SF-36) questionnaire

Timepoint [1]

Baseline and week 4

Secondary outcome [2]

Nutrition assessment by subjective global assessment (SGA)

Timepoint [2]

Baseline

Secondary outcome [3]

Information about dietary intake will be obtained using the multiple-pass 24-hour food recall method.

Timepoint [3]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

30/03/2012

Actual

24/08/2024

Date of last participant enrolment

Anticipated

Actual

24/08/2024

Date of last data collection

Anticipated

Actual

24/08/2024

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Hospital

Name

Northern Hospital

Address

185 Cooper St
Epping VIC 3076

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Deakin University

Address [1]

School of Exercise and Nutrition Science
Burwood Hwy
Burwood VIC 3125

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Health Human Research Ethics Committee

Ethics committee address [1]

185 Cooper St
Epping VIC 3076

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/11/2011

Approval date [1]

21/12/2011

Ethics approval number [1]

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

Dr Tim Crowe

Address

School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood VIC 3125

Country

Australia

Phone

+61 3 9251 7266

Fax

tim.crowe@deakin.edu.au

Contact person for public queries

Name

A/Prof. Tim Crowe

Address

School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood VIC 3125

Country

Australia

Phone

+61 3 9251 7266

Fax

tim.crowe@deakin.edu.au

Contact person for scientific queries

Name

A/Prof. Tim Crowe

Address

School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood VIC 3125

Country

Australia

Phone

+61 3 9251 7266

Fax

tim.crowe@deakin.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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

Source	Title	Year of Publication	DOI
Embase	Nutritional interventions for treating foot ulcers in people with diabetes.	2020	https://dx.doi.org/10.1002/14651858.CD011378.pub2

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically