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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine | Experimental | care and follow-up through telemedicine. |
|
| Conventional care | Active Comparator | care and follow-up through iterative diabetes physician consultations (conventional care and follow-up) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telemedicine | Other | Intervention group: care and follow-up through telemedicine (e-consultations)
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the incremental cost-effectiveness ratio from the french health system perspective | It is elaborated from:
| 6 months |
| 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:
|
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Inclusion Criteria:
Patients with type 1 or 2 diabetes, at least 18 years old
Patient with a diabetic foot wound :
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:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre-Yves BENHAMOU, MD PHD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Grenoble | Grenoble | 38049 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22067285 | Background | Hazenberg CE, Bus SA, Kottink AI, Bouwmans CA, Schonbach-Spraul AM, van Baal SG. Telemedical home-monitoring of diabetic foot disease using photographic foot imaging--a feasibility study. J Telemed Telecare. 2012 Jan;18(1):32-6. doi: 10.1258/jtt.2011.110504. Epub 2011 Nov 8. | |
| 21568750 | Background | Foltynski P, Ladyzynski P, Migalska-Musial K, Sabalinska S, Ciechanowska A, Wojcicki J. A new imaging and data transmitting device for telemonitoring of diabetic foot syndrome patients. Diabetes Technol Ther. 2011 Aug;13(8):861-7. doi: 10.1089/dia.2011.0004. Epub 2011 May 13. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D009938 | Organizations |
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|
| conventional | Other | conventional group: iterative diabetes physicians consultations at hospital
|
|
| 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 |
| 21134035 | Background | Bowling FL, King L, Paterson JA, Hu J, Lipsky BA, Matthews DR, Boulton AJ. Remote assessment of diabetic foot ulcers using a novel wound imaging system. Wound Repair Regen. 2011 Jan-Feb;19(1):25-30. doi: 10.1111/j.1524-475X.2010.00645.x. Epub 2010 Dec 6. |
| 17059653 | Background | Larsen SB, Clemensen J, Ejskjaer N. A feasibility study of UMTS mobile phones for supporting nurses doing home visits to patients with diabetic foot ulcers. J Telemed Telecare. 2006;12(7):358-62. doi: 10.1258/135763306778682323. |
| 15192491 | Background | Wilbright WA, Birke JA, Patout CA, Varnado M, Horswell R. The use of telemedicine in the management of diabetes-related foot ulceration: a pilot study. Adv Skin Wound Care. 2004 Jun;17(5 Pt 1):232-8. doi: 10.1097/00129334-200406000-00012. |
| 26696670 | Result | Muller M, David-Tchouda S, Margier J, Oreglia M, Benhamou PY. Comment on Rasmussen et al. A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers. Diabetes Care 2015;38:1723-1729. Diabetes Care. 2016 Jan;39(1):e9-10. doi: 10.2337/dc15-1659. No abstract available. |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003929 | Diabetic Neuropathies |
| D004472 | Health Care Economics and Organizations |