3D Camera - Telemedical Foot Ulcer Treatment

• Conditions: Diabetes Mellitus; Foot Ulcers
• Interventions: Device: Camera

• Registration Number: NCT01870934
• Lead Sponsor: Odense University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-06
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-28
• Last Update Posted: 2013-10-29
• Primary Completion: 2013-11
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

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Exclusion Criteria

• Superficial wounds (superficial skin defect with loss of substance in 5 x 5 mm)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Telemedicine, Diabetes, foot ulcer	Camera	-

Primary Outcome Measures

Name	Time	Method
Comparison of 3D image and normal assessment of wounds	outcome measure is assessed in 2013

Secondary Outcome Measures

Name	Time	Method
Comparison of 3D and 2D image assessment of wounds	november 2013

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark