Medico-economical Assessment of Telemedicine During Chronic Diabetes-related Foot Wound Management

Study Overview
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Brief Summary
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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.

Conditions
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Diabetes, Diabetic Foot Ulcer

Intervention / Treatment
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* Other: telemedicine
* Other: conventional


Participation Criteria
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Eligibility Criteria
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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))

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine<br>care and follow-up through telemedicine. | Other: telemedicine<br>* Intervention group: care and follow-up through telemedicine (e-consultations) 1 hospital consultation at inclusion time, week 0 then every 15 days, after the transmission of medical data and photos via internet by the nurse, telemedicine e-consultations until the wound has healed (week 2,week 4, week 6, week 8, week 10, week 12, week 14, week 16, week 18, week 20, week 22, week 24 : end point study), i.e. 12 e-consultations over a 6-month period. 1 hospital consultation to validate that the wound is well-healed<br>|
| Active Comparator: Conventional care<br>care and follow-up through iterative diabetes physician consultations (conventional care and follow-up) | Other: conventional<br>* conventional group: iterative diabetes physicians consultations at hospital 1 consultation at inclusion time, week 0 1 consultation 2 weeks after inclusion, week 2 1 consultation per month until the wound has healed (week 4, week 8, week 12, week 16, week 20, week 24: end-point study), i.e. 6 consultations over a 6-month period 1 consultation to validate that the wound is well-healed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the incremental cost-effectiveness ratio from the french health system perspective | It is elaborated from: Main cost criteria: transport, outpatient costs (home nursing care, physicians consultations...), loss of productivity (absence from work) Main clinical effectiveness criterion: wound healing time. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the Impact of telemedicine care from the hospital perspective | The incremental cost-effectiveness ratio is calculated from the hospital perspective: Main cost criteria will be collected according to the micro-costing method: costs of innovative medical device (implementation and maintenance of telemedicine platform), telemedicine physician consultations, standard consumables, cost of care rooms and cost of medical and paramedical staff and, standard consumables for wound treatment. Costs will not include structural costs Main clinical effectiveness criterion: wound healing time | 6 months | 
| Assess acceptability of telemedicine care (compliance and satisfaction) for patients and nurses. | Acceptability questionnaire for nurse including use or misuse of telemedicine. Acceptability questionnaire for patient. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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innovative care, telemedicine, cost effectiveness, diabetes