Difficulties in recruiting eligible participants

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.

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.

Assessment of the primary study outcome was by independent blinded assessment of digital photographic images, by assessors who did not undertake study visits and who were unaware of the participant's allocated treatment.