Evaluation of 3D Imaging Ulcer Camera

Overview

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.

Full Title of Study: “Evaluation of Three-dimensional Measurements of Wounds Using a Newly Developed 3D Camera”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: March 1, 2017

Detailed Description

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.

Clinical Trial Outcome Measures

Primary Measures

  • Wound 2D area
    • Time Frame: 1 day
    • Measured by 3D camera and 2D image method
  • Wound 3D area
    • Time Frame: 1 day
    • Measured by 3D camera
  • Wound perimeter
    • Time Frame: 1 day
    • Measured by 3D camera
  • Wound volume
    • Time Frame: 1 day
    • Measured by 3D camera

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with wounds – 18 years or older Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Odense University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Line Bisgaard Jørgensen, MD, PhD student – Odense University Hospital
  • Overall Official(s)
    • Knud Yderstræde, MD, PhD, Principal Investigator, Odense University Hospital

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