The number of heel pressure ulcers amongst patients on an orthopaedic ward who wear Prevalon boots or alternative heel protection over a 10 day period

The incidence of heel pressure ulcers among orthopaedic patients who wear Prevalon boots or alternative heel protection: Exploratory study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14788194

Enrollment

Registered

2017-12-04

Start date

2017-11-01

Completion date

Unknown

Last updated

2018-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure ulcer Injury, Occupational Diseases, Poisoning Pressure ulcer

Interventions

This is a randomised controlled study (RCT) to investigate the effectiveness of Prevalon Boots when used to prevent heel pressure injury among orthopaedic hospital patients. Willing patients who meet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Over 18 years old 2. In-patient within designated orthopaedic ward 3. No visible heel pressure damage of category I heel ulcer only 4. Considered vulnerable to developing pressure ulcers based on pressure ulcer risk assessment score and mobility or activity restrictions 5. Able to provide informed consent 6. No lower limb amputations 7. Ankle-brachial pressure index (ABPI) between 0.8 and 1.3 at baseline

Exclusion criteria

Exclusion criteria: 1. Under 18 years old 2. Visible heel pressure damage (category II and above) 3. Not at risk of developing pressure ulcers 4. Unable to provide informed consent 5. Lower limb amputation 6. ABPI under 0.8 or above 1.3 at baseline 7. Patients who have participated in a clinical trial on wound healing within the past month 8. Patients with a known history of non-adherence with medical treatment

Design outcomes

Primary

Measure	Time frame
1. Incidence of new heel pressure damage is measured assessing the surrounding skin from the photographs at baseline,days one, two, three, four, five, six, seven, eight, nine and 10 2. Resolution of category I heel pressure damage is measured conducting an assessment of the surrounding skin using the photograph of the patients heels. The assessor of the photographs will be blinded to the treatment arms of the patients	—

Measure

Time frame

1. Incidence of new heel pressure damage is measured assessing the surrounding skin from the photographs at baseline,days one, two, three, four, five, six, seven, eight, nine and 10 2. Resolution of category I heel pressure damage is measured conducting an assessment of the surrounding skin using the photograph of the patients heels. The assessor of the photographs will be blinded to the treatment arms of the patients

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Secondary

Measure	Time frame
1. Patient comfort is measured by asking the patients questions about their experience at baseline (prior to randomization), day five, and day 10 2. Patient acceptance of the heel protectors is measured by asking questions about the patient’s experience at baseline (prior to randomization), day five, and day 10 3. Staff acceptance of the heel protectors is measured by asking questions about the staff’s experience at baseline (prior to randomization), day five, and day 10	—

Measure

Time frame

1. Patient comfort is measured by asking the patients questions about their experience at baseline (prior to randomization), day five, and day 10 2. Patient acceptance of the heel protectors is measured by asking questions about the patient’s experience at baseline (prior to randomization), day five, and day 10 3. Staff acceptance of the heel protectors is measured by asking questions about the staff’s experience at baseline (prior to randomization), day five, and day 10

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026