Diabetic Foot UlcerNCT04336176
Evaluating Plantar Foot Pressure in a Novel Diabetic Offloading Device
A study testing PulseFlow DF boot in people with Diabetic Foot Ulcer, run by University of Leeds at 1 site in United Kingdom.
Trial summary
The impacts from diabetes are both patient related and healthcare based. Offloading is recognised as the priority treatment for healing neuropathic and neuro-ischaemic plantar foot ulcers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- PulseFlow DF boot
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Mar 2018to 29 Jul 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Plantar forefoot diabetic foot ulcer over the 1st, 2nd, 3rd, 4th or 5th MTP joints
- Neuropathic or Neuro-Ischaemic classification foot ulcer (taken from the TEXAS classification system)
- Orthotic intervention for offloading/usual standard
- English speaking and reading
- Palpable foot pulses and/or Ankle Brachial Pressure Indices of values 0.8 to 1.29.
Who cannot join
- Being treated for or having an active Charcot Arthropathy
- Ankle Brachial Pressure Indices of <0.8 and >1.29. Using a standardised reproducible instrument called the Huntleigh Dopplex Ability Unit (DA100PB).
- Purely ischaemic classification foot ulcer
- Clinically active Infection causing lower leg swelling
- Current active osteomyelitis
- Due to alterations in gait, patients with diagnosed vascular dementia, Parkinson's, alcoholism or other major medically related gait alterations i.e. intoxication, brain cancers, muscular degeneration diseases, inflammatory arthritis, etc. This does not include osteo-arthritis.
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- Fractures of the foot
- Pregnancy
- Patients with forefoot trans metatarsal or major amputations
- Temporary, accommodating or footwear not designed to offload used as their USC
- Under another trial regarding foot dressings or off loading -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does a Novel Diabetic Foot Offloading Boot Reduce the Pressure Time Integral Compared to Usual Standard Care, in Patients With Diabetic Foot Ulcer? A Proof of Concept Pilot Study
The impacts from diabetes are both patient related and healthcare based. Offloading is recognised as the priority treatment for healing neuropathic and neuro-ischaemic plantar foot ulcers. The new PulseFlow DF boot is a device which claims to off load but has little or no evidence on diabetic foot ulcer (DFU) subjects. Thus the primary aim of this study is to observe forefoot plantar pressures in a cross sectional purposively selected sample compared to usual standard of care.
Read the detailed description
The impacts from diabetes are both patient related and healthcare based. DFU is associated with a high mortality rate at 34% at 1 year. There is an associated higher limb amputation rate from DFU than other causes. The high mortality rate, high amputation rate and increased socio-economic burden means providing high quality evidence based DFU service provision should be a NHS priority. Offloading is recognised as the priority treatment for healing neuropathic and neuro-ischaemic plantar foot ulcers. Since the provision of non removable devices or total contact casts (TCC) is poor, options have to be available that are equivalent in effectiveness at off loading and healing DFU. By improving the quality of offloading choices and acceptability for devices this will improve healing rates and reduce the cost burden where currently in the UK diabetic foot care in 2015 accounted for 0.6%/585.5million pounds of the NHS budget. The evidence for effectiveness of non removable devices is poor. Therefore any device that offloads to the equivalent or more than previous devices and current usual standard of care must be evidenced. The new PulseFlow DF boot is such a device which claims to off load but has little or no evidence on DFU subjects. Thus the primary aim of this study is to observe forefoot plantar pressures in a cross sectional purposively selected sample compared to usual standard of care.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- PulseFlow DF boot, Usual standard of care, Sham
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulseFlow DF bootDevice
Offloading boot
Usual standard of careDevice
Usual standard of care (offloading device)
ShamDevice
Sham shoe (closest to barefoot or baseline pressures)
| Study group | Role | What they receive |
|---|---|---|
| PulseFlow DF boot | Active comparator | PulseFlow DF boot Receives: Device: PulseFlow DF boot; Device: Usual standard of care; Device: Sham |
| Usual Care | Active comparator | Measurements will be taken from patients wearing usual standard of care Receives: Device: PulseFlow DF boot; Device: Usual standard of care; Device: Sham |
| Sham | Sham comparator | Sham shoe (closest to barefoot or baseline pressures) Receives: Device: PulseFlow DF boot; Device: Usual standard of care; Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Time Integral
Gait analysis
Measured: 1 day
Secondary outcomes (1)
Modified Monitoring Orthopaedic Shoes questionnaire
Multiple choice questionnaire and visual analogue pain scale measuring relevant factors of use and usability of orthopaedic shoes from a patient's perspective.
Measured: 1 day (post gait analaysis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start22 Mar 2018
- Primary completion29 Jun 2018
- Study completion29 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Proof of concept study comparing the ability to redistribute forefoot pressure using a new foot offloading device compared to usual standard care. The sample will be purposively selected taken from a local population of active diabetic foot ulcer patients. The measurements will be taken from patients wearing usual standard of care, sham shoe (closest to barefoot or baseline pressures) and the PulseFlow DF boot. The measurements from each patient will be collated to compute pti averages for the comparison
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust
- Responsible party
- Principal investigator, Anne-Maree Keenan, University of Leeds
- Investigators
- Anne-Maree Keenan, PhD, Study chair, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336176
- Sponsor's protocol ID
- 17/NS/0027
- Status last verified
- Apr 2020
- First submitted
- 26 Mar 2020
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Novel Diabetic Foot Offloading Boot Reduce the Pressure Time Integral Compared to Usual Standard Care, in Patients With Diabetic Foot Ulcer? A Proof of Concept Pilot Study
- ClinicalTrials.gov ID
- NCT04336176
- Acronym / sponsor ID
- 17/NS/0027
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 29 Jul 2018 (actual)
- First posted
- 7 Apr 2020 (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 impacts from diabetes are both patient related and healthcare based. Offloading is recognised as the priority treatment for healing neuropathic and neuro-ischaemic plantar foot ulcers. The new PulseFlow DF boot is a device which claims to off load but has little or no evidence on diabetic foot ulcer (DFU) subjects. Thus the primary aim of this study is to observe forefoot plantar pressures in a cross sectional purposively selected sample compared to usual standard of care.
Detailed description
The impacts from diabetes are both patient related and healthcare based. DFU is associated with a high mortality rate at 34% at 1 year. There is an associated higher limb amputation rate from DFU than other causes. The high mortality rate, high amputation rate and increased socio-economic burden means providing high quality evidence based DFU service provision should be a NHS priority. Offloading is recognised as the priority treatment for healing neuropathic and neuro-ischaemic plantar foot ulcers. Since the provision of non removable devices or total contact casts (TCC) is poor, options have to be available that are equivalent in effectiveness at off loading and healing DFU. By improving the quality of offloading choices and acceptability for devices this will improve healing rates and reduce the cost burden where currently in the UK diabetic foot care in 2015 accounted for 0.6%/585.5million pounds of the NHS budget. The evidence for effectiveness of non removable devices is poor. Therefore any device that offloads to the equivalent or more than previous devices and current usual standard of care must be evidenced. The new PulseFlow DF boot is such a device which claims to off load but has little or no evidence on DFU subjects. Thus the primary aim of this study is to observe forefoot plantar pressures in a cross sectional purposively selected sample compared to usual standard of care.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Proof of concept study comparing the ability to redistribute forefoot pressure using a new foot offloading device compared to usual standard care. The sample will be purposively selected taken from a local population of active diabetic foot ulcer patients. The measurements will be taken from patients wearing usual standard of care, sham shoe (closest to barefoot or baseline pressures) and the PulseFlow DF boot. The measurements from each patient will be collated to compute pti averages for the comparison
| Arm | Type | Receives |
|---|---|---|
| PulseFlow DF boot | Active comparator | Device: PulseFlow DF boot, Device: Usual standard of care, Device: ShamPulseFlow DF boot |
| Usual Care | Active comparator | Device: PulseFlow DF boot, Device: Usual standard of care, Device: ShamMeasurements will be taken from patients wearing usual standard of care |
| Sham | Sham comparator | Device: PulseFlow DF boot, Device: Usual standard of care, Device: ShamSham shoe (closest to barefoot or baseline pressures) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Plantar forefoot diabetic foot ulcer over the 1st, 2nd, 3rd, 4th or 5th MTP joints
- Neuropathic or Neuro-Ischaemic classification foot ulcer (taken from the TEXAS classification system)
- Orthotic intervention for offloading/usual standard
- English speaking and reading
- Palpable foot pulses and/or Ankle Brachial Pressure Indices of values 0.8 to 1.29.
Key exclusion criteria (11 listed)
- Being treated for or having an active Charcot Arthropathy
- Ankle Brachial Pressure Indices of <0.8 and >1.29. Using a standardised reproducible instrument called the Huntleigh Dopplex Ability Unit (DA100PB).
- Purely ischaemic classification foot ulcer
- Clinically active Infection causing lower leg swelling
- Current active osteomyelitis
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 |
|---|---|---|
| PulseFlow DF bootOffloading boot | Device | PulseFlow DF boot, Sham, Usual Care |
| Usual standard of careUsual standard of care (offloading device) | Device | PulseFlow DF boot, Sham, Usual Care |
| ShamSham shoe (closest to barefoot or baseline pressures) | Device | PulseFlow DF boot, Sham, Usual Care |
Primary outcome
Pressure Time Integral
Time frame: 1 day
Gait analysis
1 secondary outcome
Modified Monitoring Orthopaedic Shoes questionnaire
Time frame: 1 day (post gait analaysis)
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 7 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Anne-Maree Keenan, PhD study chair
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PulseFlow DF boot in people with Diabetic Foot Ulcer, run by University of Leeds 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 5 inclusion and 11 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 7 Apr 2020. 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. 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?
Pressure Time Integral (time frame: 1 day). 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 7 Apr 2020.