Pressure UlcerNCT04023981
Parafricta Bootees vs UK Standard Care to Prevent Heel Pressure Ulcers
A study testing Parafricta bootees in people with Pressure Ulcer and Pressure Injury, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
Trial summary
This randomised study will assess whether Parafricta bootees, when used in addition to normal standard care, can reduce the incidence of heel PUs in patients at very high risk of skin breakdown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer, Pressure Injury, Heel Ulcer
- What is being tested?
- Parafricta bootees
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Oct 2017to 30 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The eligibility criteria for this study at the time of recruitment were:
- Adult of age 18 years or over
- Admitted to secondary care in an in-patient hospital (with no specified interval from admission to hospital to study recruitment)
- Bedbound or unable to walk independently and requiring assistance to transfer to a chair
- 'Very high' risk group for pressure ulceration (defined by a Waterlow Score of 20 or more)
- No existing heel pressure ulcers of EPUAP/NPUAP/PPPIA Category 1 or above or any other type of wound on the feet.
- Patient was not being treated with pressure offloading boots.
- Patient was not being treated with a heel cast.
Who cannot join
- Patients with a single or double lower limb amputation were not eligible to participate in the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cedar, Cardiff & Vale University Health Board
Cardiff, CF14 4UJ
About this study
Official title: Parafricta Bootees Compared to UK Standard Care to Prevent Heel Pressure Ulcers: a Multicentre Pragmatic Randomised Controlled Trial With Blinded Assessment at Three Days and at Fourteen Days.
This randomised study will assess whether Parafricta bootees, when used in addition to normal standard care, can reduce the incidence of heel PUs in patients at very high risk of skin breakdown. The participant group will be hospital inpatients at high risk of PUs (Waterlow score of 20 or more) who are bedbound and do not have existing heel PUs. The participants will be randomised to an intervention arm using Parafricta plus standard care, or a control arm of standard care only. The primary outcome is incidence of heel PUs at day 3. Secondary outcomes are incidence of PUs at day 14, length of stay, severity of PUs, patient acceptability of device, cost-effectiveness.
- Conditions
- Pressure Ulcer, Pressure Injury, Heel Ulcer
- Being tested
- Parafricta bootees
- Keywords
- Parafricta, Pressure ulcer
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parafricta booteesDevice
Parafricta bootees are a medical device designed to eliminate skin damage due to friction and shear. The basis of Parafricta bootees is a low friction material and bi-layer construction to make the material of the bootee slide on itself when movement of the foot would otherwise bring friction and shear to bear on the skin.
| Study group | Role | What they receive |
|---|---|---|
| Standard care alone | No intervention | Patients randomly allocated to standard care will be cared for on the appropriate mattress indicated for use in that participating centre according to local policy e.g. foam mattress or dynamic air mattress. Standard care may also include a mattress overlay or the use of a wedge or pillows to maintain the position of the participant, or pressure offloading boots on the foot if the need arises during the study period. |
| Parafricta bootees plus standard care | Experimental | Patients randomly allocated to Parafricta plus standard care will be cared for on the appropriate mattress as above and care may possibly include a mattress overlay or the use of a wedge or pillows. Participants will in addition be issued with Parafricta bootees (one pair and up to two spare pairs). The patient and clinical staff and the patient's carers will be instructed in the use of Parafricta bootees, which are intended to be worn throughout the day and night and removed only for normal daily washing or examination of the patient's feet. Either the slip-on bootees or the Velco-closure bootees will be selected for the participant at the judgment of the clinical ward nurses. Receives: Device: Parafricta bootees |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of heel pressure ulcers of EPUAP NPUAP/PPPIA Category 1 or above
Incidence of heel pressure ulcers of EPUAP NPUAP/PPPIA Category 1 or above on Visit 2 (Day 3), assessed by examination of digital images by two independent expert assessors who are blinded to the participants' allocated treatment.
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start26 Oct 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Why it stopped: Difficulties in recruiting eligible participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Collaborators
- Welsh Wound Innovation Centre
- Responsible party
- Principal investigator, Dr Grace Carolan-Rees, Cardiff and Vale University Health Board
- Investigators
- Grace Carolan-Rees, Prof, Study director, Cedar, Cardiff & Vale University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023981
- Sponsor's protocol ID
- WA/17/0051
- Status last verified
- Jul 2019
- First submitted
- 16 Jul 2019
- Last updated
- 18 Jul 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 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parafricta Bootees Compared to UK Standard Care to Prevent Heel Pressure Ulcers: a Multicentre Pragmatic Randomised Controlled Trial With Blinded Assessment at Three Days and at Fourteen Days.
- ClinicalTrials.gov ID
- NCT04023981
- Acronym / sponsor ID
- WA/17/0051
- Conditions
- Pressure Ulcer, Pressure Injury, Heel Ulcer
- Keywords
- Parafricta, Pressure ulcer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in recruiting eligible participants
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Collaborators
- Welsh Wound Innovation Centre
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 18 Jul 2019 (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.
This randomised study will assess whether Parafricta bootees, when used in addition to normal standard care, can reduce the incidence of heel PUs in patients at very high risk of skin breakdown. The participant group will be hospital inpatients at high risk of PUs (Waterlow score of 20 or more) who are bedbound and do not have existing heel PUs. The participants will be randomised to an intervention arm using Parafricta plus standard care, or a control arm of standard care only. The primary outcome is incidence of heel PUs at day 3. Secondary outcomes are incidence of PUs at day 14, length of stay, severity of PUs, patient acceptability of device, cost-effectiveness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care alone | No intervention | –Patients randomly allocated to standard care will be cared for on the appropriate mattress indicated for use in that participating centre according to local policy e.g. foam mattress or dynamic air mattress. Standard care may also include a mattress overlay or the use of a wedge or pillows to maintain the position of the participant, or pressure offloading boots on the foot if the need arises during the study period. |
| Parafricta bootees plus standard care | Experimental | Device: Parafricta booteesPatients randomly allocated to Parafricta plus standard care will be cared for on the appropriate mattress as above and care may possibly include a mattress overlay or the use of a wedge or pillows. Participants will in addition be issued with Parafricta bootees (one pair and up to two spare pairs). The patient and clinical staff and the patient's carers will be instructed in the use of Parafricta bootees, which are intended to be worn throughout the day and night and removed only for normal daily washing or examination of the patient's feet. Either the slip-on bootees or the Velco-closure bootees will be selected for the participant at the judgment of the clinical ward nurses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult of age 18 years or over
- Admitted to secondary care in an in-patient hospital (with no specified interval from admission to hospital to study recruitment)
- Bedbound or unable to walk independently and requiring assistance to transfer to a chair
- 'Very high' risk group for pressure ulceration (defined by a Waterlow Score of 20 or more)
- No existing heel pressure ulcers of EPUAP/NPUAP/PPPIA Category 1 or above or any other type of wound on the feet.
Key exclusion criteria (1 listed)
- Patients with a single or double lower limb amputation were not eligible to participate in the study.
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 |
|---|---|---|
| Parafricta booteesParafricta bootees are a medical device designed to eliminate skin damage due to friction and shear. The basis of Parafricta bootees is a low friction material and bi-layer construction to make the material of the bootee slide on itself when movement of the foot would otherwise bring friction and shear to bear on the skin. | Device | Parafricta bootees plus standard care |
Primary outcome
Incidence of heel pressure ulcers of EPUAP NPUAP/PPPIA Category 1 or above
Time frame: Day 3
Incidence of heel pressure ulcers of EPUAP NPUAP/PPPIA Category 1 or above on Visit 2 (Day 3), assessed by examination of digital images by two independent expert assessors who are blinded to the participants' allocated treatment.
Results and safety
The study was stopped early (reason given: Difficulties in recruiting eligible participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 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.
Grace Carolan-Rees, Prof study director
Cedar, Cardiff & Vale University Health Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parafricta bootees in people with Pressure Ulcer and Pressure Injury, run by Cardiff and Vale University Health Board 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 8 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: stopped early, as of the sponsor's last update on 18 Jul 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 was stopped early (reason given: Difficulties in recruiting eligible participants). Results are not available in the source record.
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?
Incidence of heel pressure ulcers of EPUAP NPUAP/PPPIA Category 1 or above (time frame: Day 3). 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 18 Jul 2019.