Parafricta Bootees vs UK Standard Care to Prevent Heel Pressure Ulcers

Pressure Ulcer Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04023981
• Other study ID #: WA/17/0051
• Status: Terminated
• Phase: N/A
• Start date: October 26, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: July 2019
• Source: Cardiff and Vale University Health Board
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Crush Injuries
• Heel Ulcer
• Pressure Injury
• Pressure Ulcer
• Ulcer

Intervention

Device:
• Parafricta bootees
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.

Locations

Country	Name	City	State
United Kingdom	Cedar, Cardiff & Vale University Health Board	Cardiff

Sponsors (2)

Lead Sponsor	Collaborator
Cardiff and Vale University Health Board	Welsh Wound Innovation Centre

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 3