NCT03063138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 24, 2017

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

1.6 years

First QC Date

February 21, 2017

Last Update Submit

September 18, 2017

Conditions

Diabetes MellitusDiabetic Foot UlcerWoundChronic Disease

Keywords

Diabetic foot ulcerMeasurementWound healingMeasurement deviceThree-dimensional measurements

Outcome Measures

Primary Outcomes (4)

  • Wound 2D area

    Measured by 3D camera and 2D image method

    1 day

  • Wound 3D area

    Measured by 3D camera

    1 day

  • Wound perimeter

    Measured by 3D camera

    1 day

  • Wound volume

    Measured by 3D camera

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with wounds from University Centre for Wound Healing, Odense University Hospital.

You may qualify if:

  • Patients with wounds
  • years or older

You may not qualify if:

  • Superficial ulcer (less than 5x5 mm with no substantial loss of subcutaneous tissue)
  • Non-compliance (dementia, mental disorders)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Centre of Wound Healing, Odense University Hospital (OUH)

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetic FootWounds and InjuriesChronic Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetic NeuropathiesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Knud Yderstræde, MD, PhD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD student

Study Record Dates

First Submitted

February 21, 2017

First Posted

February 24, 2017

Study Start

August 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

September 19, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)