Parafricta Bootees vs UK Standard Care to Prevent Heel Pressure Ulcers

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.

NCT04023981•Cardiff and Vale University Health Board

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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. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Locations (1)

Cedar, Cardiff & Vale University Health Board

Cardiff, United Kingdom

Key Dates

Start Date

October 26, 2017

Primary Completion Date

April 30, 2018

Completion Date

April 30, 2018

Last Updated

July 18, 2019

Enrollment

ACTUAL participants

Conditions

Pressure UlcerPressure InjuryHeel Ulcer

Interventions

Parafricta bootees

DEVICE

Italian Validation of a Pressure Injury Risk Assessment Scale (Braden QDS) in the Neonatal Intensive Care Unit

NCT07425418

Pressure Ulcers in the Neonatal Population

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RECRUITINGNA

Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries

NCT05496296

Pressure Ulcers Stage IIPressure Ulcers Stage III+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Parafricta Bootees vs UK Standard Care to Prevent Heel Pressure Ulcers

Inclusion Criteria

Italian Validation of a Pressure Injury Risk Assessment Scale (Braden QDS) in the Neonatal Intensive Care Unit

Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries

Prevention of Pressure Ulcers in Patients at Medium to High Risk of Pressure Ulcers Using the R'GO SOINS Overlay Mattress

Comparing Aloe Vera Gel and Rosemary Oil in Pressure Injury Prevention

The Effect of Pressure Ulcer Care Package on the Risk of Pressure Ulcer Development

Sumamos Excelencia Project: Implementation of Best Practices in Clinical Practice (Thrid Edition)