Chronic and Non-healing WoundsNCT03355599
Investigating the Benefits of a 3D Camera for Recording Healing Wound Dimensions
A study testing 3d camera in people with Chronic and Non-healing Wounds, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The study will explore whether a 3D camera data can provide a more accurate baseline measurement (compared to 2D images with manual measurement) to support better clinical decision making in referrals to tissue viability. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic and Non-healing Wounds
- What is being tested?
- 3d camera
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jul 2017to 29 Dec 2017
- Phase
- Interventional
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a non-healing wound and be over 18 years of age the criteria for non-healing wounds is as per 5.1 on the community nursing referral criteria when considering referral of patients to tissue viability:
- 'would expect that the wounds are deteriorating, chronic, non-healing or static or there are problems with the dressing regime'
- Patients must be willing to provide written informed consent
- Patients must have a registered Sheffield General Practitioner and be referred to tissue viability for a static or deteriorating wound
Who cannot join
- Patients with circumferential leg ulcers
- Patients with deep narrow sinus where the opening is less than 10mm
- Wounds on the face where the image would include the eyes or distinguishing features
- Patients unable to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF
About this study
The study will explore whether a 3D camera data can provide a more accurate baseline measurement (compared to 2D images with manual measurement) to support better clinical decision making in referrals to tissue viability.
Read the detailed description
Chronic and non-healing wounds are a significant problem to manage in community and represent a significant workload in community nursing. The current management for non-healing wounds includes referral to the tissue viability service, using a 2 D photographic image with assessment information. This study will pilot the use of a 3 D camera and associated software that introduces measurement and monitoring of wounds as a specific intervention. The introduction of 3 D measurement and monitoring of wounds will be compared with usual care. With a target recruitment of 30 patients via tissue viability, the pilot will report on the feasibility of using this outcome measure and the effectiveness of monitoring on wound closure or improvement.
- Conditions
- Chronic and Non-healing Wounds
- Being tested
- 3d camera
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3d cameraOther
3 D camera and associated software that introduces measurement and monitoring of wounds as a specific intervention
| Study group | Role | What they receive |
|---|---|---|
| 3d camera | Other | 3d camera Receives: Other: 3d camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparative consistency of the image
comparative reliability and consistency of the image between 2d and 3d images
Measured: 1 week
comparative consistency of the measurement
comparative reliability and consistency of the measurements between 2d and 3d images
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start10 Jul 2017
- Primary completion29 Dec 2017
- Study completion29 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic and Non-healing WoundsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brenda King, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355599
- Sponsor's protocol ID
- STH19655
- Status last verified
- Feb 2019
- First submitted
- 22 Nov 2017
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Benefits of a 3D Camera for Recording Healing Wound Dimensions
- ClinicalTrials.gov ID
- NCT03355599
- Acronym / sponsor ID
- STH19655
- Conditions
- Chronic and Non-healing Wounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 29 Dec 2017 (actual)
- Study completion
- 29 Dec 2017 (actual)
- First posted
- 28 Nov 2017 (actual)
- 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.
The study will explore whether a 3D camera data can provide a more accurate baseline measurement (compared to 2D images with manual measurement) to support better clinical decision making in referrals to tissue viability.
Detailed description
Chronic and non-healing wounds are a significant problem to manage in community and represent a significant workload in community nursing. The current management for non-healing wounds includes referral to the tissue viability service, using a 2 D photographic image with assessment information. This study will pilot the use of a 3 D camera and associated software that introduces measurement and monitoring of wounds as a specific intervention. The introduction of 3 D measurement and monitoring of wounds will be compared with usual care. With a target recruitment of 30 patients via tissue viability, the pilot will report on the feasibility of using this outcome measure and the effectiveness of monitoring on wound closure or improvement.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3d camera | Other | Other: 3d camera3d camera |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must have a non-healing wound and be over 18 years of age the criteria for non-healing wounds is as per 5.1 on the community nursing referral criteria when considering referral of patients to tissue viability:
- 'would expect that the wounds are deteriorating, chronic, non-healing or static or there are problems with the dressing regime'
- Patients must be willing to provide written informed consent
- Patients must have a registered Sheffield General Practitioner and be referred to tissue viability for a static or deteriorating wound
Key exclusion criteria (4 listed)
- Patients with circumferential leg ulcers
- Patients with deep narrow sinus where the opening is less than 10mm
- Wounds on the face where the image would include the eyes or distinguishing features
- Patients unable to provide written informed consent.
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 camera3 D camera and associated software that introduces measurement and monitoring of wounds as a specific intervention | Other | 3d camera |
Primary outcome
comparative consistency of the image
Time frame: 1 week
comparative reliability and consistency of the image between 2d and 3d images
comparative consistency of the measurement
Time frame: 1 week
comparative reliability and consistency of the measurements between 2d and 3d images
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 15 Feb 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.
Brenda King principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3d camera in people with Chronic and Non-healing Wounds, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 4 inclusion and 4 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 15 Feb 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 United Kingdom. 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?
comparative consistency of the image (time frame: 1 week). 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 15 Feb 2019.