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| Name | Class |
|---|---|
| Region of Southern Denmark | OTHER |
| European Commission | OTHER |
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Telemedicine technology enables a direct and online text- and image communication in the treatment system from patient to the ulcer specialist. The technology is expected to have patient-related, economic and therapeutic benefits. The study is a substudy of a larger project entitled "Renewing Health", where also the economic and management aspects are highlighted. However, only few randomized prospective studies are conducted in this field. The purpose of the study is in a randomized prospective study, to assess the impact of the introduction of the telemedicine technology as consultation form between ulcer-nurses in the primary sector and the wound clinics at the hospitals in the region. It is assessed whether the technology can be adopted without incurring the patient a risk. The study aims to perform an impact analysis of the introduction of new technologies for telemedicine wound monitoring in the treatment of diabetic foot ulcers through different studies.
Through randomized and prospective studies the project will show whether a telemedicine approach to wound care can be used as an alternative to traditional attendance at a wound clinic and document whether this consultation form provides a greater patient-satisfaction and cost savings. The project will document that telemedicine is equivalent to conventional outpatient attendance from a therapeutic aspect in terms of number of hospitalizations, number of extra controls, acute interventions and wound healing.
The project is also investigating the extent of time spent on the personnel side using telemedicine consultations compared with conventional outpatient appearances.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Control group. Regular treatment. | |
| Diabetes ulcer monitoring | Experimental | Receives a telemedicine intervention: Diabetes ulcer monitoring. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telemedicine consultations | Procedure | Replacing 2 out of 3 patient visits to out-patient clinic at hospital with treatment at home from visiting nurse and telemedicine consultations with the specialist doctor. |
| Measure | Description | Time Frame |
|---|---|---|
| Admissions to hospital | The number of admissions, incl, beddays, to hospital relating to ulcer treatment for each randomised patient during the treatment period. | from time of inclusion until treatment completed, assessed up to 52 weeks |
| Surgical procedures | The number of surgical procedures (incl. amputations) performed at hospital in realtion to the ulcer during the treatment period. | from time of inclusion until completed treatment, assessed up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Ulcer healing | The time from inclusion and start of treatment until ulcer is healed and treatment is stopped. | Progress is measured at minimum every 4 weeks during treatment period, assessed up to 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benjamin S. Rasmussen, MD | Contact | 004560774050 | benjamin.schnack.rasmussen@ouh.regionsyddanmark.dk |
| Name | Affiliation | Role |
|---|---|---|
| Benjamin S. Rasmussen, MD | Odense University Hospital | Study Director |
| Johnny Froekjaer, MD | Odense University Hospital | Principal Investigator |
| Knud B. Yderstraede, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South-west Hospital | Recruiting | Esbjerg | Region Syddanmark | 6700 | Denmark | |
| Lillebaelt Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27638453 | Derived | Fasterholdt I, Gerstrom M, Rasmussen BSB, Yderstraede KB, Kidholm K, Pedersen KM. Cost-effectiveness of telemonitoring of diabetic foot ulcer patients. Health Informatics J. 2018 Sep;24(3):245-258. doi: 10.1177/1460458216663026. Epub 2016 Sep 16. | |
| 26116717 | Derived | Rasmussen BS, Froekjaer J, Bjerregaard MR, Lauritsen J, Hangaard J, Henriksen CW, Halekoh U, Yderstraede KB. A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers. Diabetes Care. 2015 Sep;38(9):1723-9. doi: 10.2337/dc15-0332. Epub 2015 Jun 26. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D016523 | Foot Ulcer |
| 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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|
| Odense University Hospital |
| Study Chair |
| Recruiting |
| Kolding |
| Region Syddanmark |
| 6000 |
| Denmark |
| Odense University Hospital | Recruiting | Odense | Region Syddanmark | 5000 | Denmark |
| Svendborg Hospital | Recruiting | Svendborg | Region Syddanmark | 5700 | Denmark |
| Hospital South Jutland | Recruiting | Sønderborg | Region Syddanmark | 6400 | Denmark |
| Hospital Lillebaelt | Recruiting | Vejle | Region Syddanmark | 7100 | Denmark |
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003929 | Diabetic Neuropathies |