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Three-dimensional Measurements of Diabetic Foot Ulcers

NCT02423850 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2019-03-13

No results posted yet for this study

Summary

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 ulcer is one of the major etiologic factors for delayed healing. Wound measurement is important in the monitoring of the wound healing process. For the last decade different 3D (three-dimensional) techniques for measuring wounds have been proposed in order to measure wound volume, but none of the technologies have been widely used. A 3D Wound Assessment Monitor (WAM) camera has been developed, which is able to measure wound size in 3D and to assess wound characteristics.

The investigators hypothesize that three-dimensional measurements of diabetic foot ulcers are feasible in the assessment of wound healing. A prospective cohort study is conducted in which newly admitted patients with a diabetic foot ulcer are included at the first visit at the multidisciplinary clinic. The patients are followed for one year or until complete wound healing, amputation or death. The four wound measurements: 2D area, 3D area, perimeter and volume are measured using the 3D-WAM camera with frequent intervals. Patient anthropometrics and wound data are collected during the study and correlated to the wound healing.

Conditions

  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • Diabetes Complications
  • Diabetic Foot

Interventions

DEVICE

3D Wound Assessment Monitor (WAM) camera

Three-dimensional wound measurement (2D area, 3D area, perimeter, volume) using 3D-WAM camera

Sponsors & Collaborators

  • University of Southern Denmark

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Knud Yderstræde, MD, PhD · Department of Endocrinology, Odense University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02423850 on ClinicalTrials.gov