3D Camera - Telemedical Foot Ulcer Treatment

NCT ID: NCT01870934

Last Updated: 2013-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-11-30

Brief Summary

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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

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Conditions

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Diabetes Mellitus Foot Ulcers

Keywords

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Telemedicine Diabetes Foot Ulcers

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Telemedicine, Diabetes, foot ulcer

Camera

Intervention Type DEVICE

No real intervention, but a comparison of different methods including the new medical device 3D camera.

Interventions

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Camera

No real intervention, but a comparison of different methods including the new medical device 3D camera.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Johnny Froekjaer

Research responsible Chief Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benjamin Schnack Rasmussen, M.D

Role: PRINCIPAL_INVESTIGATOR

Odense University Hosptial

Knud Yderstræde, MD, Ph.d.

Role: STUDY_CHAIR

Odense University Hospital

Locations

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Odense University Hospital

Odense, Odense, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Benjamin Sc Rasmussen, M.D.

Role: CONTACT

Email: [email protected]

Benjamin Schnack Sc Rasmussen

Role: CONTACT

Facility Contacts

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Benjamin Sc Rasmussen, M.D.

Role: primary

Other Identifiers

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12-08-00621

Identifier Type: OTHER

Identifier Source: secondary_id

OUH3D01

Identifier Type: -

Identifier Source: org_study_id