Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Three-dimensional Measurements for Monitoring Wound Healing of Diabetic Foot Ulcers
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.
Method
Newly admitted patients with a diabetic foot ulcer are included at the first visit in the
multidisciplinary clinic. The data mentioned below are collected at the first visit and the
following examinations are performed including 3D photos. The wound size (2D area, 3D area,
perimeter and volume) are estimated from the photos using the 3D-WAM camera. The wound
examination is repeated after 2, 4, 8, 12, 24, 36 and 52 weeks or until healing of the wound.
The wound healing is estimated using changes in wound size per time unit. Patients are
treated by standard ulcer treatment methods and are unaffected by the project per se. During
the trial the different methods of treatment are noted including changes from initial
treatment. The variables will be quantified after one year depending on time to heal,
establishment of a chronic ulcer (non-healing after one year) or an amputation has been
performed.
At baseline the following patient data will be collected:
- Demographic data: gender, age
- Smoking habits
- Time period between onset of wound to first visit in the multidisciplinary clinic
- Body Mass Index
- Comorbidity using Charlson Comorbidity Index score
- Type of diabetes, duration of diabetes
- Diabetic complications including retinopathy, albuminuria, coronary heart diseases and
neuropathy
The following examinations will be performed at baseline:
- Blood pressure measurement
- Peripheral blood pressure
- Examination for neuropathy using monofilament
- Blood samples from patients with a diabetic foot ulcer
The clinical examination of the ulcer are performed at baseline and after 2, 4, 8, 12, 24, 36
and 52 weeks or until wound healing:
- Size of wound (2D area, 3D area, perimeter, volume) measured using the 3D-WAM camera
- Size of wound in 2D area using the digital imaging method with the software ImageJ
- Location of the ulcer
- Classification of ulcer: granulation, necrosis, epithelialisation
- Secretory potential
- Foot deformity
- Bone affection - if osteitis is suspected an x-ray is taken
- Signs of infection
The different types of ulcer treatment is registered for every ulcer:
- Type of bandage
- Antibiotics (local, systemic)
- Revision (method, frequency),
- Surgery
Effect variables
- Wound 2D area, 3D area, perimeter and volume
- Variation in 2D and 3D area measurements during the study period
- Percentage change in wound size after 2, 4, 8, 12, 24, 36 and 52 weeks
Endpoints
- Wound healing
- Amputations
- Chronic wound (non-healing after 1 year)
- Death
Significance
This project seeks to clarify whether 3D photos of wounds will provide accurate structural
measures to illuminate the background for delayed ulcer healing, and thereby to create
platform for a more evidence based treatment algorithm.
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