Evaluation of 3D Imaging Ulcer Camera

Completed

• Conditions: Chronic Disease; Diabetic Foot Ulcer; Diabetes Mellitus; Wound

• Registration Number: NCT03063138
• Lead Sponsor: Odense University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-08-01
• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-24
• Primary Completion: 2017-03-01
• Study Completion: 2017-03-01
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-18
• Last Update Posted: 2017-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wound 2D area	1 day	Measured by 3D camera and 2D image method
Wound 3D area	1 day	Measured by 3D camera
Wound perimeter	1 day	Measured by 3D camera
Wound volume	1 day	Measured by 3D camera

Trial Locations

Locations (1)

University Centre of Wound Healing, Odense University Hospital (OUH); 🇩🇰 Odense, Denmark