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Evaluation of 3D Imaging Ulcer Camera (3D-DFU)

O

Odense University Hospital

Status

Completed

Conditions

Wound
Chronic Disease
Diabetes Mellitus
Diabetic Foot Ulcer

Study type

Observational

Funder types

Other

Identifiers

NCT03063138
OUH3D03

Details and patient eligibility

About

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 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.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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