Diabetic FootPhase 1DFUPSNCT02317835
Diabetic Foot Ulcer Prevention System
A Phase 1 study testing DFUPS in people with Diabetic Foot, run by King's College Hospital NHS Trust at 3 sites in United Kingdom.
Trial summary
To evaluate a recently developed non-invasive infrared thermal camera called Diabetic Foot Ulcer Prevention System (DFUPS) in a clinical setting by studying healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- DFUPS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jul 2015to Apr 2016
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Has no history of diabetes
- Has no previous history of foot ulceration
- Has no previous history of foot surgery
- Has palpable foot pulses on both feet (palpable posterior tibial artery pulse OR dorsalis pedis artery pulse OR both)
- Has no history of peripheral neuropathy
- Has no history of peripheral arterial disease
- Must be able to provide meaningful written informed consent for the study
Who cannot join
- Has active foot ulceration and infection
- Has foot deformity which in the opinion of the Investigator, would interfere with interpreting the results of the study
- Has any uncontrolled illness that, in the opinion of the Investigator, would interfere with interpreting the results of the study
- Has an implantable electronic device
- Is aged <18
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
King's College Hospital
London, SE5 9RS
The Pennine Acute Hospitals NHS Trust
Manchester, M9 4BE
The Newcastle upon Tyne Hospitals
Newcastle upon Tyne, NE3 3HD
About this study
Official title: An Innovative System for the Early Identification, Monitoring, Evaluation and Diagnosis of Diabetic Foot Ulcers
To evaluate a recently developed non-invasive infrared thermal camera called Diabetic Foot Ulcer Prevention System (DFUPS) in a clinical setting by studying healthy volunteers.
- Conditions
- Diabetic Foot
- Being tested
- DFUPS
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFUPSDevice
The DFUPS device is a two-camera instrument for capturing images of feet
| Study group | Role | What they receive |
|---|---|---|
| Study in healthy volunteers | Other | Skin foot temperature measurement by DFUPS device Receives: Device: DFUPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of hot spots on a foot thermal map image
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startJul 2015
- Primary completionDec 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies 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 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Physical Laboratory, University of South Wales, Freeman Health System, Pennine Acute Hospitals NHS Trust, National Institute for Health Research, United Kingdom, Photometrix
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317835
- Sponsor's protocol ID
- version 2 (02/3/2015)
- Acronym
- DFUPS
- Status last verified
- Jun 2016
- First submitted
- 10 Dec 2014
- Last updated
- 9 Jun 2016
- Results posted
- No
Publications
Petrova NL, Whittam A, MacDonald A, Ainarkar S, Donaldson AN, Bevans J, Allen J, Plassmann P, Kluwe B, Ring F, Rogers L, Simpson R, Machin G, Edmonds ME. Reliability of a novel thermal imaging system for temperature assessment of healthy feet. J Foot Ankle Res. 2018 May 30;11:22. doi: 10.1186/s13047-018-0266-1. eCollection 2018.
PubMed 29854007
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative System for the Early Identification, Monitoring, Evaluation and Diagnosis of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT02317835
- Acronym / sponsor ID
- DFUPS / version 2 (02/3/2015)
- Conditions
- Diabetic Foot
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- National Physical Laboratory, University of South Wales, Freeman Health System, Pennine Acute Hospitals NHS Trust, National Institute for Health Research, United Kingdom, Photometrix
- Study start
- Jul 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 17 Dec 2014 (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.
To evaluate a recently developed non-invasive infrared thermal camera called Diabetic Foot Ulcer Prevention System (DFUPS) in a clinical setting by studying healthy volunteers.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study in healthy volunteers | Other | Device: DFUPSSkin foot temperature measurement by DFUPS device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18 years or older
- Has no history of diabetes
- Has no previous history of foot ulceration
- Has no previous history of foot surgery
- Has palpable foot pulses on both feet (palpable posterior tibial artery pulse OR dorsalis pedis artery pulse OR both)
Key exclusion criteria (5 listed)
- Has active foot ulceration and infection
- Has foot deformity which in the opinion of the Investigator, would interfere with interpreting the results of the study
- Has any uncontrolled illness that, in the opinion of the Investigator, would interfere with interpreting the results of the study
- Has an implantable electronic device
- Is aged <18
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 |
|---|---|---|
| DFUPSThe DFUPS device is a two-camera instrument for capturing images of feet | Device | Study in healthy volunteers |
Primary outcome
Detection of hot spots on a foot thermal map image
Time frame: 9 months
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 9 Jun 2016.
- Derived from this study: PubMed 29854007Petrova NL, Whittam A, MacDonald A, Ainarkar S, Donaldson AN, Bevans J, Allen J, Plassmann P, Kluwe B, Ring F, Rogers L, Simpson R, Machin G, Edmonds ME. Reliability of a novel thermal imaging system for temperature assessment of healthy feet. J Foot Ankle Res. 2018 May 30;11:22. doi: 10.1186/s13047-018-0266-1. eCollection 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DFUPS in people with Diabetic Foot, run by King's College Hospital NHS Trust at 3 sites 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 8 inclusion and 5 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 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Detection of hot spots on a foot thermal map image (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02317835, which also lists 1 linked publication.
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 9 Jun 2016.