Diabetes Mellitus, Type 1NCT02423850
Three-dimensional Measurements of Diabetic Foot Ulcers
An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Complications
- What is being tested?
- 3D Wound Assessment Monitor (WAM) camera
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2015to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly admitted patients with diabetic foot ulcer to University Centre for Wound Healing, Odense University Hospital.
Who may be able to join
- Newly admitted patients with diabetic foot ulcers
- 18 years or older
Who cannot join
- Superficial wound (less than 5x5 mm with no substantial loss of subcutaneous tissue)
- Non-compliance (dementia, mental disorders)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University Centre of Wound Healing, Odense University Hospital (OUH)
Odense, 5000
About this study
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.
Read the detailed description
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.
- Conditions
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Complications, Diabetic Foot
- Being tested
- 3D Wound Assessment Monitor (WAM) camera
- Keywords
- Diabetic foot ulcers, Ulcer healing, Ulcer measurement, Ulcer area, Ulcer volume, 3D measurement
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Complications, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Wound Assessment Monitor (WAM) cameraDevice
Also called 3D-WAM camera
Three-dimensional wound measurement (2D area, 3D area, perimeter, volume) using 3D-WAM camera
| Study group | Role | What they receive |
|---|---|---|
| Diabetic foot ulcers | Newly referred patients with diabetic foot ulcers from the multidisciplinary clinic: University Centre for Wound healing, Odense University Hospital, Denmark. Receives: Device: 3D Wound Assessment Monitor (WAM) camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
The variability in 2D area (digital imaging method) and 3D area wound measurements (3D-WAM camera) at week 0, 2, 4, 8, 12, 24, 36 and 52 are compared
Measured: Photos are taken at week 0, 2, 4, 8, 12, 24, 36 and 52 weeks
Diabetes type is compared to outcome of the wound
Type 1 and 2
Measured: Baseline until healing, amputation or chronic wound (52 weeks)
Diabetes duration is compared to outcome of the wound
In years
Measured: Baseline until healing, amputation or chronic wound (52 weeks)
BMI (kg/m2) is compared to outcome of the wound
kg/m2
Measured: Baseline until healing, amputation or chronic wound (52 weeks)
Charlson index score is compared to outcome of the wound
In groups
Measured: Baseline until healing, amputation or chronic wound (52 weeks)
HbA1c is compared to outcome of the wound
mmol/mol
Measured: Baseline until healing, amputation or chronic wound (52 weeks)
Ischemia is compared to outcome of the wound
Ischemia is defined by ankle pressure below 70 mmHg and/or toe pressure below 45 mmHg
Measured: Baseline until healing, amputation or chronic wound (52 weeks)
Neuropathy is compared to outcome of the wound
Neuropathy is measured by Semmes Weinstein monofilament examination
Measured: Baseline until healing, amputation or chronic wound (52 weeks)
Wound duration is compared to outcome of the wound
In weeks
Measured: Baseline until healing, amputation or chronic wound (52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Principal investigator, Line Bisgaard Jørgensen, Odense University Hospital
- Investigators
- Knud Yderstræde, MD, PhD, Principal investigator, Department of Endocrinology, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423850
- Sponsor's protocol ID
- OUH3D02
- Status last verified
- Mar 2019
- First submitted
- 15 Apr 2015
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Measurements for Monitoring Wound Healing of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT02423850
- Acronym / sponsor ID
- OUH3D02
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- Aug 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic foot ulcers | – | Device: 3D Wound Assessment Monitor (WAM) cameraNewly referred patients with diabetic foot ulcers from the multidisciplinary clinic: University Centre for Wound healing, Odense University Hospital, Denmark. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly admitted patients with diabetic foot ulcer to University Centre for Wound Healing, Odense University Hospital.
Key inclusion criteria (2 listed)
- Newly admitted patients with diabetic foot ulcers
- 18 years or older
Key exclusion criteria (2 listed)
- Superficial wound (less than 5x5 mm with no substantial loss of subcutaneous tissue)
- Non-compliance (dementia, mental disorders)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D Wound Assessment Monitor (WAM) cameraAlso: 3D-WAM cameraThree-dimensional wound measurement (2D area, 3D area, perimeter, volume) using 3D-WAM camera | Device | Diabetic foot ulcers |
Primary outcome
Wound healing change quantified using the 3D-WAM camera
Time frame: Photos are taken at week 0, 2, 4, 8, 12, 24, 36 and 52 weeks
The 3D wound measurements at week 2, 4, 8, 12, 24, 36 and 52 are compared to the baseline measurement at week 0.
Wound healing change quantified using digital imaging method
Time frame: Photos are taken at week 0, 2, 4, 8, 12, 24, 36 and 52 weeks
The 2D wound measurements at week 2, 4, 8, 12, 24, 36 and 52 are compared to the baseline measurement at week 0.
9 secondary outcomes
The variability in 2D area and 3D area measurements
Time frame: Photos are taken at week 0, 2, 4, 8, 12, 24, 36 and 52 weeks
Diabetes type is compared to outcome of the wound
Time frame: Baseline until healing, amputation or chronic wound (52 weeks)
Diabetes duration is compared to outcome of the wound
Time frame: Baseline until healing, amputation or chronic wound (52 weeks)
BMI (kg/m2) is compared to outcome of the wound
Time frame: Baseline until healing, amputation or chronic wound (52 weeks)
Charlson index score is compared to outcome of the wound
Time frame: Baseline until healing, amputation or chronic wound (52 weeks)
HbA1c is compared to outcome of the wound
Time frame: Baseline until healing, amputation or chronic wound (52 weeks)
Ischemia is compared to outcome of the wound
Time frame: Baseline until healing, amputation or chronic wound (52 weeks)
Neuropathy is compared to outcome of the wound
Time frame: Baseline until healing, amputation or chronic wound (52 weeks)
Wound duration is compared to outcome of the wound
Time frame: Baseline until healing, amputation or chronic wound (52 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Knud Yderstræde, MD, PhD principal investigator
Department of Endocrinology, Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing change quantified using the 3D-WAM camera (time frame: Photos are taken at week 0, 2, 4, 8, 12, 24, 36 and 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.