Evaluation of 3D Imaging Ulcer Camera

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

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-01

Study Completion Date

2017-03-01

Brief Summary

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The aim of the study is to evaluate the intra- and inter-rater variability of wound measurements using the 3D camera and to compare with standard measurement methods (2D image method and gel injection). Forty-eight patients with wounds of various sizes are measured by four clinicians. Each wound is measured twice with the 3D camera, once by 2D image method and once by gel injection into wound cavity by two clinicians.

Detailed Description

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Diabetic foot ulcers constitute an increasing health problem in Denmark concurrent with an ageing population and an increase in diabetes prevalence. Diabetic foot ulcers belong to the most serious and costly complications. Several studies have found that the size and depth of the wound is one of the major etiologic factors for delayed healing. Wound measurement is important in monitoring the healing process of wound and in evaluating the effect of treatment. Three-dimensional methods for measuring wound size have made it possible to evaluate the process of wound healing with respect to all dimensions. The investigators have developed a 3D camera, which is able to measure wound size (2D area, 3D area, perimeter and volume) and to assess wound characteristics.

The aim of the study is to evaluate the intra- and inter-rater variability of wound measurements using the 3D camera and to compare with standard measurement methods (2D image method and gel injection). Forty-eight patients with wounds of various sizes are measured by four clinicians. Each wound is measured twice with the 3D camera, once by 2D image method and once by gel injection into wound cavity by two clinicians.

Conditions

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Diabetes Mellitus Diabetic Foot Ulcer Wound Chronic Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with wounds
* 18 years or older

Exclusion Criteria

* Superficial ulcer (less than 5x5 mm with no substantial loss of subcutaneous tissue)
* Non-compliance (dementia, mental disorders)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Line Bisgaard Jørgensen

MD, PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Knud Yderstræde, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

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University Centre of Wound Healing, Odense University Hospital (OUH)

Odense, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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OUH3D03

Identifier Type: -

Identifier Source: org_study_id