Evaluation of 3D Imaging Ulcer Camera

Diabetes Mellitus Clinical Trial

— 3D-DFU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03063138
• Other study ID #: OUH3D03
• Status: Completed
• Phase: N/A
• First received: February 21, 2017
• Last updated: September 18, 2017
• Start date: August 1, 2015
• Est. completion date: March 1, 2017

Study information

• Verified date: September 2017
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Disease
• Diabetes Mellitus
• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer
• Wound

Locations

Country	Name	City	State
Denmark	University Centre of Wound Healing, Odense University Hospital (OUH)	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound 2D area	Measured by 3D camera and 2D image method	1 day
Primary	Wound 3D area	Measured by 3D camera	1 day
Primary	Wound perimeter	Measured by 3D camera	1 day
Primary	Wound volume	Measured by 3D camera	1 day