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Evaluation of 3D Imaging Ulcer Camera

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03063138
Acronym
3D-DFU
Enrollment
48
Registered
2017-02-24
Start date
2015-08-01
Completion date
2017-03-01
Last updated
2017-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Disease, Diabetes Mellitus, Diabetic Foot Ulcer, Wound

Keywords

Diabetic foot ulcer, Measurement, Wound healing, Measurement device, Three-dimensional measurements

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.

Interventions

None listed

Sponsors

Odense University Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Wound 2D area1 dayMeasured by 3D camera and 2D image method
Wound 3D area1 dayMeasured by 3D camera
Wound perimeter1 dayMeasured by 3D camera
Wound volume1 dayMeasured by 3D camera

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026