Trial Review

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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] 287758 0
Nil Known
Universal Trial Number (UTN)
-
Trial acronym
-
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Foot Ulcer 296636 0
Condition category
Condition code
Metabolic and Endocrine 296870 296870 0 0
Diabetes
Skin 296900 296900 0 0
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] 293156 0
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] 296472 0
Partial or complete closure of foot ulcer will be assessed using specialized 3-D camera.
Timepoint [1] 296472 0
Healing rate: Week 1 will be compared with week 12
Secondary outcome [1] 318524 0
Proportion of participants who achieve a significant (20%) reduction of serum levels of interleukin 6 (IL-6)
Timepoint [1] 318524 0
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?
No
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
40
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4531 0
The Townsville Hospital - Douglas
Recruitment hospital [2] 4532 0
Ingham Hospital - Ingham
Recruitment hospital [3] 4533 0
Ayr Hospital - Ayr
Recruitment hospital [4] 4534 0
Charters Towers Hospital - Charters Towers
Recruitment hospital [5] 4535 0
Joyce Palmer Health Service - Palm Island
Recruitment postcode(s) [1] 12147 0
4814 - Douglas
Recruitment postcode(s) [2] 12148 0
4850 - Ingham
Recruitment postcode(s) [3] 12149 0
4807 - Ayr
Recruitment postcode(s) [4] 12150 0
4820 - Charters Towers
Recruitment postcode(s) [5] 12151 0
4816 - Palm Island

Funding & Sponsors
Funding source category [1] 292299 0
Charities/Societies/Foundations
Name [1] 292299 0
Australian Diabetes Society
Country [1] 292299 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
100 Angus Smith Drive
Douglas, Townsville
QLD 4814.
Country
Australia
Secondary sponsor category [1] 290982 0
Individual
Name [1] 290982 0
Professor Usman H. Malabu: FRACP
Address [1] 290982 0
James Cook University and Townsville Hospital
100 Angus Smith Drive
Douglas, Townsville
QLD 4814.
Country [1] 290982 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293775 0
Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 293775 0
100 Angus Smith Drive
Douglas, Townsville
QLD 4814.
Ethics committee country [1] 293775 0
Australia
Date submitted for ethics approval [1] 293775 0
25/11/2014
Approval date [1] 293775 0
27/04/2015
Ethics approval number [1] 293775 0
-

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 61246 0
Prof Usman H. Malabu
Address 61246 0
James Cook University and Townsville Hospital
100 Angus Smith Drive
Douglas, Townsville
QLD 4814
Country 61246 0
Australia
Phone 61246 0
+61-7-4433 1111
Fax 61246 0
+61-7-4433 2239
Email 61246 0
[email protected]
Contact person for public queries
Name 61247 0
Prof Usman H. Malabu
Address 61247 0
James Cook University and Townsville Hospital
100 Angus Smith Drive
Douglas, Townsville
QLD 4814
Country 61247 0
Australia
Phone 61247 0
+61-7-4433 1111
Fax 61247 0
+61-7-4433 2239
Email 61247 0
[email protected]
Contact person for scientific queries
Name 61248 0
Prof Usman H. Malabu
Address 61248 0
100 Angus Smith Drive
Douglas, Townsville
QLD 4814
Country 61248 0
Australia
Phone 61248 0
+61-7-4433 1111
Fax 61248 0
+61-7-4433 2239
Email 61248 0
[email protected]

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?
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4319Study protocol  [email protected]
4320Statistical analysis plan  [email protected]
4321Informed consent form  [email protected]
4322Ethical approval  [email protected]



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.