Diabetes MellitusNCT01870934
3D Camera - Telemedical Foot Ulcer Treatment
An observational study of Diabetes Mellitus and Foot Ulcers, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Diabetic foot ulcers are deep wounds that occur as a result of nerve damage in the feet (peripheral neuropathy). Amputation is a common consequence of diabetic foot ulcers; approximately 85% of all diabetes-related amputations are caused by foot ulcers. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes Mellitus, Foot Ulcers
- What is being tested?
- Camera
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to Nov 2013
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic foot ulcers patients
Who may be able to join
- Patients with diabetic foot ulcers, which has been the diagnosis, stratification (eg ischemia, neuropathy, etc.) and treatment according to current guidelines refer "Diabetic Foot Study Group". Age 18-90 years
Who cannot join
- Superficial wounds (superficial skin defect with loss of substance in 5 x 5 mm)
Trial locations and contacts
1 site in 1 country.
Benjamin Sc Rasmussen, M.D. contact
Benjamin Schnack Sc Rasmussen contact
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense, Odense, 5000
Benjamin Sc Rasmussen, M.D., benjamin.rasmussen@ouh.regionsyddanmark.dk
Knud Yderstræde, M.D, Phd.
About this study
Official title: A Feasibility Study on the Development of 3D Optic Ulcer Camera
Diabetic foot ulcers are deep wounds that occur as a result of nerve damage in the feet (peripheral neuropathy). Amputation is a common consequence of diabetic foot ulcers; approximately 85% of all diabetes-related amputations are caused by foot ulcers. The ulcer treatment is extensive, resource demanding and highly specialized and necessitates involvement of patient, hospital and local in-home care personnel.
The 3D photo optic camera project aims at a much more efficient and precise method for diagnosis and treatment of foot ulcers. The Department of Endocrinology and the section for LEAN and Innovation at Odense University Hospital has developed a prototype for a 3D camera that takes pictures and measurements of the ulcer that can provide the basis for correct diagnosis and treatment of the ulcer. The camera was developed in close cooperation with TECCLUSTER A/S, Svendborg Municipality, Team Online and ComMed.
- Conditions
- Diabetes Mellitus, Foot Ulcers
- Being tested
- Camera
- Keywords
- Telemedicine, Diabetes, Foot Ulcers
- Medical subject headings
- Diabetes Mellitus, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CameraDevice
No real intervention, but a comparison of different methods including the new medical device 3D camera.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine, Diabetes, foot ulcer | Not described Receives: Device: Camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of 3D image and normal assessment of wounds
Measured: outcome measure is assessed in 2013
Secondary outcomes (1)
Comparison of 3D and 2D image assessment of wounds
Measured: november 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionNov 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johnny Froekjaer, Odense University Hospital
- Investigators
- Benjamin Schnack Rasmussen, M.D, Principal investigator, Odense University HosptialKnud Yderstræde, MD, Ph.d., Study chair, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870934
- Sponsor's protocol ID
- OUH3D01
- Other IDs
- 12-08-00621
- Status last verified
- Oct 2013
- First submitted
- 4 Jun 2013
- Last updated
- 29 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study on the Development of 3D Optic Ulcer Camera
- ClinicalTrials.gov ID
- NCT01870934
- Acronym / sponsor ID
- OUH3D01
- Conditions
- Diabetes Mellitus, Foot Ulcers
- Keywords
- Telemedicine, Diabetes, Foot Ulcers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 6 Jun 2013 (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 are deep wounds that occur as a result of nerve damage in the feet (peripheral neuropathy). Amputation is a common consequence of diabetic foot ulcers; approximately 85% of all diabetes-related amputations are caused by foot ulcers. The ulcer treatment is extensive, resource demanding and highly specialized and necessitates involvement of patient, hospital and local in-home care personnel.
The 3D photo optic camera project aims at a much more efficient and precise method for diagnosis and treatment of foot ulcers. The Department of Endocrinology and the section for LEAN and Innovation at Odense University Hospital has developed a prototype for a 3D camera that takes pictures and measurements of the ulcer that can provide the basis for correct diagnosis and treatment of the ulcer. The camera was developed in close cooperation with TECCLUSTER A/S, Svendborg Municipality, Team Online and ComMed.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telemedicine, Diabetes, foot ulcer | – | Device: Camera |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic foot ulcers patients
Key inclusion criteria (1 listed)
- Patients with diabetic foot ulcers, which has been the diagnosis, stratification (eg ischemia, neuropathy, etc.) and treatment according to current guidelines refer "Diabetic Foot Study Group". Age 18-90 years
Key exclusion criteria (1 listed)
- Superficial wounds (superficial skin defect with loss of substance in 5 x 5 mm)
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 |
|---|---|---|
| CameraNo real intervention, but a comparison of different methods including the new medical device 3D camera. | Device | Telemedicine, Diabetes, foot ulcer |
Primary outcome
Comparison of 3D image and normal assessment of wounds
Time frame: outcome measure is assessed in 2013
1 secondary outcome
Comparison of 3D and 2D image assessment of wounds
Time frame: november 2013
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
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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.
Benjamin Sc Rasmussen, M.D. contact
Benjamin Schnack Sc Rasmussen contact
Benjamin Schnack Rasmussen, M.D principal investigator
Odense University Hosptial
Knud Yderstræde, MD, Ph.d. study chair
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 and Foot Ulcers, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Oct 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Sc Rasmussen, M.D. (bsr@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of 3D image and normal assessment of wounds (time frame: outcome measure is assessed in 2013). 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 29 Oct 2013.