- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01870934
3D Camera - Telemedical Foot Ulcer Treatment
A Feasibility Study on the Development of 3D Optic Ulcer Camera
Diabetic foot ulcers are deep wounds that occur as a result of nerve damage in the feet (peripheral neuropathy). Amputation is a common consequence of diabetic foot ulcers; approximately 85% of all diabetes-related amputations are caused by foot ulcers. The ulcer treatment is extensive, resource demanding and highly specialized and necessitates involvement of patient, hospital and local in-home care personnel.
The 3D photo optic camera project aims at a much more efficient and precise method for diagnosis and treatment of foot ulcers. The Department of Endocrinology and the section for LEAN and Innovation at Odense University Hospital has developed a prototype for a 3D camera that takes pictures and measurements of the ulcer that can provide the basis for correct diagnosis and treatment of the ulcer. The camera was developed in close cooperation with TECCLUSTER A/S, Svendborg Municipality, Team Online and ComMed.
Studieoversigt
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Odense, Danmark, 5000
- Rekruttering
- Odense University Hospital
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Kontakt:
- Benjamin Sc Rasmussen, M.D.
- E-mail: benjamin.rasmussen@ouh.regionsyddanmark.dk
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Underforsker:
- Knud Yderstræde, M.D, Phd.
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients with diabetic foot ulcers, which has been the diagnosis, stratification (eg ischemia, neuropathy, etc.) and treatment according to current guidelines refer "Diabetic Foot Study Group". Age 18-90 years
Exclusion Criteria:
- Superficial wounds (superficial skin defect with loss of substance in 5 x 5 mm)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Telemedicine, Diabetes, foot ulcer
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No real intervention, but a comparison of different methods including the new medical device 3D camera.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Comparison of 3D image and normal assessment of wounds
Tidsramme: outcome measure is assessed in 2013
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outcome measure is assessed in 2013
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Comparison of 3D and 2D image assessment of wounds
Tidsramme: november 2013
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november 2013
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Benjamin Schnack Rasmussen, M.D, Odense University Hosptial
- Studiestol: Knud Yderstræde, MD, Ph.d., Odense University Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- OUH3D01
- 12-08-00621 (Anden identifikator: CIV-ID)
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