ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615001215516

Ethics application status

Approved

Date submitted

1/11/2015

Date registered

6/11/2015

Date last updated

3/09/2019

Date data sharing statement initially provided

3/09/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Clinical and Economic Impact of Telemedicine in Management of Diabetes Foot Ulcer in Rural/Remote areas of North Queensland: A Pilot Study

Scientific title

Clinical and Economic Impact of Telemedicine in Management of Diabetes Foot Ulcer in Rural/Remote areas of North Queensland: A Pilot Study

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Diabetic Foot Ulcer

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Skin

Other skin conditions

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Fifty diabetic foot ulcer subjects residing in rural areas will receive 20-minute standard of wound care (sharp debridement and normal saline dressing). It will be administered by a local nurse fortnightly for 3 months in liaison with podiatrist and endocrinologist at The Townsville Hospital linked via dedicated T1 line on the Queensland Health telemedicine to advice on ulcer healing and opinion on treatment of wound infection respectively. Wound ulcer healing will be monitored electronically using a specialized 3-D camera.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Fifty diabetic foot ulcer subjects residing in rural areas will travel to The Townsville Hospital (tertiary centre) to receive 20-minute standard of wound care (sharp debridement and normal saline dressing). It will be administered by podiatrist/endocrinologist fortnightly for 3 months. Wound ulcer healing will be monitored electronically using a specialized 3-D camera.

Control group

Active

Outcomes

Primary outcome [1]

Partial or complete closure of foot ulcer will be assessed using specialized 3-D camera.

Timepoint [1]

Healing rate: Week 1 will be compared with week 12

Secondary outcome [1]

Proportion of participants who achieve a significant (20%) reduction of serum levels of interleukin 6 (IL-6)

Timepoint [1]

The IL-6 will be compared at week 1 and week 12

Eligibility

Key inclusion criteria

Patients meeting the following inclusion criteria will be eligible to enter the study:

1. Diabetic foot ulcer of full-thickness skin defect requiring more than 14 days of healing.
2. Lives >50 km from The Townsville Hospital.
3. Exclusion of other etiologies of foot ulcer.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients meeting any of the following criteria will not be included in the study:

1. Clinically significant lower-extremity ischemia (as defined by an ankle/brachial index of <0.65).
2. Planned surgical intervention for the diabetic foot ulcer.
3. Significant medical conditions that would impair wound healing will also be excluded from the study. These conditions include hepatic, respiratory or cardiac failures, aplastic anemia, scleroderma and malignancy, treatment with immunosuppressive agents or steroids.
4. Ulcer of a non-diabetic pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis-related ulcers, calciphylaxis or dystrophic calcinosis cutis).
5. Active malignancy other than basal cell carcinoma as well as subjects with cancerous or pre-cancerous lesions in the ulcer area.
6. Inability to comply with study protocol.

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)

All subjects who fit the selection criteria will be invited to participate and if willing will be provided with information on the study and participant consent will be obtained and then randomized. Patients in each stratum will be assigned numbers using a central stratified randomization scheme.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomization list will be prepared by an independent statistician by the method of computer-generated random numbers for each treatment. Patients in each stratum will be assigned numbers using a central stratified randomization scheme designed to provide 1:1 of patients in the 2 groups. Patients will be randomized to usual or telemedicine group. An interim analysis will be performed after recruiting 50% of the proposed study participants.

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

Clinical and biochemical data of the subjects will be represented as absolute numbers and percentages while chi-square test will be performed to test for association between two categorical factors. For continuous data that are not normally distributed Mann-Whitney U test will be performed using SPSS version 22.0 (Chicago, IL, USA). Results will be considered statistically significant at a p value less than 0.05.

Cost-effectiveness will be expressed as an Incremental Cost-Effectiveness Ratio (ICER), which will be calculated as incremental costs divided by incremental effects. The results will be presented in cost-effectiveness planes and cost-effectiveness acceptability curves (CEACs). Furthermore, prospective cost-savings from use of telemedicine in rural areas will be analysed using a one-way sensitivity analysis to test the robustness of findings in net savings. Savings in this model will be attributed to: (a) avoiding travel by the patients and escorts to a tertiary centre; and (b) avoiding overnight accommodation for patients and escorts in Townsville. Savings from avoiding travel by patients to a tertiary centre will be calculated by multiplying return travel cost for two people (the patient and one escort) by the number of consultations as determined and fully reimbursed by the Queensland Health Patient Subsidy Scheme (PTSS).

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/01/2016

Actual

1/02/2016

Date of last participant enrolment

Anticipated

27/04/2022

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

The Townsville Hospital - Douglas

Recruitment hospital [2]

Ingham Hospital - Ingham

Recruitment hospital [3]

Ayr Hospital - Ayr

Recruitment hospital [4]

Charters Towers Hospital - Charters Towers

Recruitment hospital [5]

Joyce Palmer Health Service - Palm Island

Recruitment postcode(s) [1]

4814 - Douglas

Recruitment postcode(s) [2]

4850 - Ingham

Recruitment postcode(s) [3]

4807 - Ayr

Recruitment postcode(s) [4]

4820 - Charters Towers

Recruitment postcode(s) [5]

4816 - Palm Island

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Australian Diabetes Society

Address [1]

145 Macquarie Street, Sydney NSW 2000

Country [1]

Australia

Primary sponsor type

University

Name

James Cook University

Address

100 Angus Smith Drive
Douglas, Townsville
QLD 4814.

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Professor Usman H. Malabu: FRACP

Address [1]

James Cook University and Townsville Hospital
100 Angus Smith Drive
Douglas, Townsville
QLD 4814.

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Townsville Hospital and Health Service Human Research Ethics Committee

Ethics committee address [1]

100 Angus Smith Drive
Douglas, Townsville
QLD 4814.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/11/2014

Approval date [1]

27/04/2015

Ethics approval number [1]

Summary

Brief summary

Diabetes foot ulcer (DFU) is a serious complication of diabetes that leads to prolonged hospitalisation and >80% of diabetes-related lower limb amputations (1). Although a number of health disparities exist between rural and urban areas in Australia, management of diabetes foot ranks as one of the most significant health concerns (2). Compared to Australian major cities, rural/remote areas experience two to three times higher rate of hospitalisation and limb amputation due to diabetes (3). Despite high prevalence of diabetic foot complications in rural/remote areas, there are surprisingly no special programs aimed at reducing the burden of the disease. Significant challenges such as access to the health care centres and staffing limitations have made quality of care comparisons between rural and urban centres difficult. Currently subjects with DFU living in rural/remote areas in the region have to travel long distances to Townsville Hospital Diabetes Centre (THDC) on weekly basis for wound care. The annual Medicare cost for care in patients with diabetes who have foot ulcer is 3 times that of patients with diabetes who do not have ulcer, with inpatient care accounting for 70% of ulcer care costs (4). A program that effectively manages foot ulcers and reduces hospital admissions could substantially reduce costs of care in diabetes. Use of telemedicine may help solve the scarcity of specialist diabetes wound care in such underserved communities in our region. 

Objectives: to assess clinical and economic impacts of telemedicine in management of foot ulcers in rural/remote areas of North Queensland.

References
1. http://www.aihw.gov.au/diabetes-indicators/lower-limb-amputations/
2. Australian Institute of health and Welfare 2012-2014 http://www.aihw.gov.au/
3. Queensland Health Patient Travel Subsidy Scheme: http://www.health.qld.gov.au/ptss/

Trial website

-

Trial related presentations / publications

-

Public notes

-

Contacts

Principal investigator

Name

Prof Usman H. Malabu

Address

James Cook University and Townsville Hospital
100 Angus Smith Drive
Douglas, Townsville
QLD 4814

Country

Australia

Phone

+61-7-4433 1111

Fax

+61-7-4433 2239

usman.malabu@jcu.edu.au

Contact person for public queries

Name

Usman H. Malabu

Address

James Cook University and Townsville Hospital
100 Angus Smith Drive
Douglas, Townsville
QLD 4814

Country

Australia

Phone

+61-7-4433 1111

Fax

+61-7-4433 2239

usman.malabu@jcu.edu.au

Contact person for scientific queries

Name

Usman H. Malabu

Address

100 Angus Smith Drive
Douglas, Townsville
QLD 4814

Country

Australia

Phone

+61-7-4433 1111

Fax

+61-7-4433 2239

usman.malabu@jcu.edu.au

Data sharing statement

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

Yes

What data in particular will be shared?

Deidentified, individual participant data underlying published results only

When will data be available (start and end dates)?

Beginning 3 months and ending 5 years following main results publication

Available to whom?

researchers who provide a methodologically sound proposal

Available for what types of analyses?

for IPD meta-analyses, etc.

How or where can data be obtained?

usman.malabu@jcu.edu.au

What supporting documents are/will be available?

Doc. No.	Type	Email
4319	Study protocol	usman.malabu@jcu.edu.au
4320	Statistical analysis plan	usman.malabu@jcu.edu.au
4321	Informed consent form	usman.malabu@jcu.edu.au
4322	Ethical approval	usman.malabu@jcu.edu.au

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.

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