Medico-economical Assessment of Telemedicine During Chronic Diabetes-related Foot Wound Management
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- University Hospital, Grenoble
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Assess the incremental cost-effectiveness ratio from the french health system perspective
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The aim of the study is to assess the cost-effectiveness of telemedicine in the care of chronic diabetic foot ulcers.
Patients will be randomized into 2 groups: 1/conventional care group with iterative visits to diabetes specialist or 2/innovative care (telemedicine group).
the health insurance system perspective is adopted.
Investigators
AdministrateurCIC
Pr Pierre-Yves BENHAMOU, University Hospital, Grenoble
University Hospital, Grenoble
Eligibility Criteria
Inclusion Criteria
- •Patients with type 1 or 2 diabetes, at least 18 years old
- •Patient with a diabetic foot wound :
- •Acute or chronic (evolving for at least 30 days)
- •size ≤ to 3 cm²
- •Level I, II or III, stage A or B, excluding stages C and D from the University of Texas Wound Classification Systems
- •Person affiliated to French Health insurance or equivalent
- •Person having signed freely the consent form after receiving sufficient information
- •Treatment compliance and 6 months follow-up feasible
Exclusion Criteria
- •Patient with a ischemic wound: Ankle-Brachial Index (ABI) \<0.9 or Transcutaneous oxygen pressure (TcpO2) \< 30 mmHg (stage C and D from the University of Texas Wound Classification Systems)
- •Patient with emergency hospitalization indication whatever the reasons.
- •Person deprived of liberty by a legal or administrative decision, patients in emergency and people hospitalised without consent and who are not protected by law.
- •Pregnant or breastfeeding women
- •Patient currently participating in another telemedicine research protocol (such as : Study on the impact of Telemedicine on the management of patients with type 1 diabetes (TELEDIAB-3))
Outcomes
Primary Outcomes
Assess the incremental cost-effectiveness ratio from the french health system perspective
Time Frame: 6 months
It is elaborated from: 1. Main cost criteria: transport, outpatient costs (home nursing care, physicians consultations...), loss of productivity (absence from work) 2. Main clinical effectiveness criterion: wound healing time.
Secondary Outcomes
- Assess acceptability of telemedicine care (compliance and satisfaction) for patients and nurses.(6 months)
- Assess the Impact of telemedicine care from the hospital perspective(6 months)