None listed
Conditions
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/
Interventions
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 us
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.
Sponsors
James Cook University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed