Three-dimensional Measurements of Diabetic Foot Ulcers

NCT02423850 | Completed DMC

• 1 other identifier: OUH3D02
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diabetic foot ulcers; Ulcer healing; Ulcer measurement; Ulcer area; Ulcer volume; 3D measurement

Outcome Measures

Primary Outcomes (2)

• Wound healing change quantified using the 3D-WAM camera

  The 3D wound measurements at week 2, 4, 8, 12, 24, 36 and 52 are compared to the baseline measurement at week 0.

  Photos are taken at week 0, 2, 4, 8, 12, 24, 36 and 52 weeks

• Wound healing change quantified using digital imaging method

  The 2D wound measurements at week 2, 4, 8, 12, 24, 36 and 52 are compared to the baseline measurement at week 0.

  Photos are taken at week 0, 2, 4, 8, 12, 24, 36 and 52 weeks

Secondary Outcomes (9)

• The variability in 2D area and 3D area measurements

  Photos are taken at week 0, 2, 4, 8, 12, 24, 36 and 52 weeks

• Diabetes type is compared to outcome of the wound

  Baseline until healing, amputation or chronic wound (52 weeks)

• Diabetes duration is compared to outcome of the wound

  Baseline until healing, amputation or chronic wound (52 weeks)

• BMI (kg/m2) is compared to outcome of the wound

  Baseline until healing, amputation or chronic wound (52 weeks)

• Charlson index score is compared to outcome of the wound

  Baseline until healing, amputation or chronic wound (52 weeks)

Other Outcomes (1)

• Quality of life (Questionaires) using 36-Item Short Form Survey (SF-36) is compared to outcome of the wound

  Baseline, 24 and 52 weeks

Study Arms (1)

Diabetic foot ulcers

Newly referred patients with diabetic foot ulcers from the multidisciplinary clinic: University Centre for Wound healing, Odense University Hospital, Denmark.

Device: 3D Wound Assessment Monitor (WAM) camera

Interventions

3D Wound Assessment Monitor (WAM) camera DEVICE

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

Also known as: 3D-WAM camera

Diabetic foot ulcers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly admitted patients with diabetic foot ulcer to University Centre for Wound Healing, Odense University Hospital.

You may qualify if:

• Newly admitted patients with diabetic foot ulcers
• years or older

You may not qualify if:

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

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Southern Denmark: collaborator

Study Sites (1)

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

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Neuropathies

Study Officials

• Knud Yderstræde, MD, PhD

  Department of Endocrinology, Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: April 22, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

DK (1)