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Clinical Trials/NCT01870934
NCT01870934
Unknown
Not Applicable

A Feasibility Study on the Development of 3D Optic Ulcer Camera

Odense University Hospital1 site in 1 country36 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Odense University Hospital
Enrollment
36
Locations
1
Primary Endpoint
Comparison of 3D image and normal assessment of wounds
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
November 2013
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Johnny Froekjaer

Research responsible Chief Surgeon

Odense University Hospital

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Comparison of 3D image and normal assessment of wounds

Time Frame: outcome measure is assessed in 2013

Secondary Outcomes

  • Comparison of 3D and 2D image assessment of wounds(november 2013)

Study Sites (1)

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