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Completed

NCT Number: NCT03063138

Evaluation of 3D Imaging Ulcer Camera

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Wound 2D area

    Time frame: 1 day

    Measured by 3D camera and 2D image method

  2. Wound 3D area

    Time frame: 1 day

    Measured by 3D camera

  3. Wound perimeter

    Time frame: 1 day

    Measured by 3D camera

  4. Wound volume

    Time frame: 1 day

    Measured by 3D camera

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

Evaluation of Three-dimensional Measurements of Wounds Using a Newly Developed 3D Camera

Acronym: 3D-DFU

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 24, 2017
Registry last updated
Sep 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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