Parafricta Bootees vs UK Standard Care to Prevent Heel Pressure Ulcers

Not Applicable

Terminated

• Conditions: Heel Ulcer; Pressure Ulcer; Pressure Injury
• Interventions: Device: Parafricta bootees

• Registration Number: NCT04023981
• Lead Sponsor: Cardiff and Vale University Health Board

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-26
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Status Verified: 2019-07
• Study First Submitted: 2019-07-16
• Study First Submitted QC: 2019-07-17
• Last Update Submitted: 2019-07-17
• Study First Posted: 2019-07-18
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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.

Exclusion Criteria

• Patients with a single or double lower limb amputation were not eligible to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parafricta bootees plus standard care	Parafricta bootees	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.

Primary Outcome Measures

Name	Time	Method
Incidence of heel pressure ulcers of EPUAP NPUAP/PPPIA Category 1 or above	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.

Trial Locations

Locations (1)

Cedar, Cardiff & Vale University Health Board; 🇬🇧 Cardiff, United Kingdom