Diabetic FootDFUPSNCT02579070
Diabetic Foot Ulcer Prevention System (DFUPS) - Part 2
A study testing DFUPS in people with Diabetic Foot, run by King's College Hospital NHS Trust at 3 sites in United Kingdom.
Trial summary
The purpose of this study is to investigate whether regular measurement of skin foot temperature with a novel device (DFUPS) will prevent ulcer recurrence in diabetic patients at high risk of foot ulceration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- DFUPS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 8 Feb 2016to 27 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Has either type 1 or type 2 diabetes
- Has intact feet as defined by the absence of a skin breakdown below the malleoli.
- Has neuropathy confirmed by impaired sensation to neurothesiometer (vibration perception threshold > 25 volts on one OR both feet)
- Has a past history of ≥1 foot ulceration (s) which has (have) resolved in the last 3 months
- Has palpable foot pulses on both feet (palpable posterior tibial artery pulse OR dorsalis pedis artery pulse OR both)
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- Has no history of peripheral arterial disease
- Has footwear which in the opinion of the investigator is not likely to cause pressure damage
- Must be able to provide meaningful written informed consent for the study
Who cannot join
- Is aged <18
- Has foot deformity that in the opinion of the investigator would interfere with the interpreting of the results of the study.
- Has previous history of foot surgery which in the opinion of the study investigator could interfere with the interpreting the results of the study
- Has active foot ulceration and infection
- Has active Charcot osteoarthropathy
- Has established Charcot foot deformity that in the opinion of the study investigator would interfere with the interpreting of the results of the study.
- Has any uncontrolled illness that, in the opinion of the study investigator, would interfere with interpreting the results of the study
- Has an implantable electronic device
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: Efficacy and Safety of Diabetic Foot Ulcer Prevention System (DFUPS) - a Single Blind Randomised Clinical Trial in Diabetic Foot Patients at High Risk of Foot Ulceration
The purpose of this study is to investigate whether regular measurement of skin foot temperature with a novel device (DFUPS) will prevent ulcer recurrence in diabetic patients at high risk of foot ulceration. It is planned to regularly measure the temperature of the feet of people with diabetes who have already had a foot ulcer which has subsequently healed. These measurements should allow the identification of hotspots on the foot and may be helpful when advising about ulcer risk and providing preventative treatment. It is hoped to find out whether the regular use of thermal images taken with the DFUPS device together with standard foot treatment may reduce the number of people with diabetes developing ulcers or even prevent foot ulcers.
- Conditions
- Diabetic Foot
- Being tested
- DFUPS
- Keywords
- Diabetic Foot, foot temperature, diabetic foot ulcer
- 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 |
|---|---|---|
| DFUPS (visual and thermal images) | Experimental | Visual and thermal imaging with DFUPS and standard foot care. The study investigator will have access to the thermal and visual images captured with DFUPS. Receives: Device: DFUPS |
| DFUPS ( visual images) | Placebo comparator | Visual and blinded thermal imaging with DFUPS and standard foot care. The study investigator will have access only to the visual images and will be blinded to the thermal images which will be captured at each visit but accessed only at the end of the study. Receives: Device: DFUPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients developing a foot ulcer
Measured: 12 months
Secondary outcomes (2)
Time to ulceration
Measured: 12 months
Rate of change of score in quality of life from baseline and up to the final visit using the EQ-5D-5L
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study start8 Feb 2016
- Primary completion27 Sep 2017
- Study completion27 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Freeman Health System, Pennine Acute Hospitals NHS Trust, National Physical Laboratory, University of South Wales, Photometrix, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Michael Edmonds, MD, FRCP, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579070
- Sponsor's protocol ID
- version 1 05/10/2015
- Acronym
- DFUPS
- Status last verified
- Sep 2019
- First submitted
- 15 Oct 2015
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Diabetic Foot Ulcer Prevention System (DFUPS) - a Single Blind Randomised Clinical Trial in Diabetic Foot Patients at High Risk of Foot Ulceration
- ClinicalTrials.gov ID
- NCT02579070
- Acronym / sponsor ID
- DFUPS / version 1 05/10/2015
- Conditions
- Diabetic Foot
- Keywords
- Diabetic Foot, foot temperature, diabetic foot ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- Freeman Health System, Pennine Acute Hospitals NHS Trust, National Physical Laboratory, University of South Wales, Photometrix, National Institute for Health Research, United Kingdom
- Study start
- 8 Feb 2016 (actual)
- Primary completion
- 27 Sep 2017 (actual)
- Study completion
- 27 Sep 2017 (actual)
- First posted
- 19 Oct 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.
The purpose of this study is to investigate whether regular measurement of skin foot temperature with a novel device (DFUPS) will prevent ulcer recurrence in diabetic patients at high risk of foot ulceration. It is planned to regularly measure the temperature of the feet of people with diabetes who have already had a foot ulcer which has subsequently healed. These measurements should allow the identification of hotspots on the foot and may be helpful when advising about ulcer risk and providing preventative treatment. It is hoped to find out whether the regular use of thermal images taken with the DFUPS device together with standard foot treatment may reduce the number of people with diabetes developing ulcers or even prevent foot ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DFUPS (visual and thermal images) | Experimental | Device: DFUPSVisual and thermal imaging with DFUPS and standard foot care. The study investigator will have access to the thermal and visual images captured with DFUPS. |
| DFUPS ( visual images) | Placebo comparator | Device: DFUPSVisual and blinded thermal imaging with DFUPS and standard foot care. The study investigator will have access only to the visual images and will be blinded to the thermal images which will be captured at each visit but accessed only at the end of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18 years or older
- Has either type 1 or type 2 diabetes
- Has intact feet as defined by the absence of a skin breakdown below the malleoli.
- Has neuropathy confirmed by impaired sensation to neurothesiometer (vibration perception threshold > 25 volts on one OR both feet)
- Has a past history of ≥1 foot ulceration (s) which has (have) resolved in the last 3 months
Key exclusion criteria (8 listed)
- Is aged <18
- Has foot deformity that in the opinion of the investigator would interfere with the interpreting of the results of the study.
- Has previous history of foot surgery which in the opinion of the study investigator could interfere with the interpreting the results of the study
- Has active foot ulceration and infection
- Has active Charcot osteoarthropathy
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 | DFUPS ( visual images), DFUPS (visual and thermal images) |
Primary outcome
Percentage of patients developing a foot ulcer
Time frame: 12 months
2 secondary outcomes
Time to ulceration
Time frame: 12 months
Rate of change of score in quality of life from baseline and up to the final visit using the EQ-5D-5L
Time frame: 12 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 17 Sep 2019.
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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.
Michael Edmonds, MD, FRCP principal investigator
King's College Hospital NHS Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A 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 9 inclusion and 8 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 17 Sep 2019. 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. Some participants in this study may receive a placebo. 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?
Percentage of patients developing a foot ulcer (time frame: 12 months). 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 17 Sep 2019.