WHITE 14-PRESSURE 3: An investigation of people 60 years and over with a broken hip to determine whether using specialised heel pressure equipment can lower the number of people developing a pressure ulcer on the heel after surgery

World Hip Trauma Evaluation Appendix 14 - Pressure Ulcer Prevention 3: A randomised clinical trial assessing early heel-specific adjunct devices for heel pressure ulcer prevention in people with a fractured hip (PRESSURE 3)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10696770

Enrollment

3102

Registered

2023-06-29

Start date

2023-07-10

Completion date

Unknown

Last updated

2026-06-15

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

Conditions

Prevention of heel pressure ulcer after surgery for a broken hip Injury, Occupational Diseases, Poisoning

Interventions

WHiTE 14-PRESSURE 3 is a randomised comparison appended to the World Hip Trauma Evaluation (WHiTE ) Platform. WHiTE is a platform trial designed to efficiently deliver multiple randomised comparisons

Eligibility

Sex/Gender

All

Age

60 Years to 110 Years

Inclusion criteria

Inclusion criteria: Current key inclusion criteria as of 05/06/2026: Platform inclusion criteria: Aged 60 years old and over presenting to a WHiTE recruitment centre for treatment of a hip fracture Additional inclusion criteria for PRESSURE 3: 1. Randomisation occurs within 4 days of diagnosis of a hip fracture 2. In the opinion of the treating clinical team, the patient may benefit from surgical treatment Previous key inclusion criteria: Platform inclusion criteria: Aged 60 years old and over presenting to a WHiTE recruitment centre for treatment of a hip fracture Additional inclusion criteria for PRESSURE 3: 1. Diagnosis of hip fracture within 48 hours of randomisation 2. In the opinion of the treating clinical team, the patient may benefit from surgical treatment

Exclusion criteria

Exclusion criteria: Platform exclusion criteria: 1. Previous participation in the same randomised comparison 2. A second hip fracture (on the other side), while the patient is still enrolled in the Platform following their first hip fracture, Additional exclusion criteria for PRESSURE 3: 3. A heel off-loading or CLP device has been assigned prior to randomisation 4. There is an existing Category 2-4 or Unstageable PU on either heel or ’not applicable' on both heels (ie no evaluable heel sites) 5. There is a contra-indication to the interventions e.g. allergy to device material

Design outcomes

Primary

Measure	Time frame
Skin status assessments of the heels will be undertaken using the international classification scale (EPUAP/NPIAP/PPPIA) by a trained member of the local research team at pre-randomisation and twice weekly up to discharge or 30 days whichever is sooner. This assessment will be used to compare the incidence of new Category =2 heel PUs from diagnosis of a hip fracture to index hospital discharge or 30 days whichever is soonest between the treatment groups	—

Measure

Time frame

Skin status assessments of the heels will be undertaken using the international classification scale (EPUAP/NPIAP/PPPIA) by a trained member of the local research team at pre-randomisation and twice weekly up to discharge or 30 days whichever is sooner. This assessment will be used to compare the incidence of new Category =2 heel PUs from diagnosis of a hip fracture to index hospital discharge or 30 days whichever is soonest between the treatment groups

—

Secondary

Measure	Time frame
Skin status assessment as described for the primary outcome measure will also be used to: 1. Compare the incidence of new Category 1 heel PUs from diagnosis of a hip fracture to index hospital discharge or 30 days whichever is soonest between treatment groups in participants with normal or Category A skin status on the heel(s) at randomisation 2. Compare the overall incidence of new Category =1 heel PUs from diagnosis of a hip fracture to index hospital discharge or 30 days whichever is soonest between treatment groups in participants with normal or Category A skin status on the heel(s) at randomisation 3. Compare the progression of Category =1 heel PUs to a higher Category from diagnosis of a hip fracture to index hospital discharge or 30 days whichever is soonest between treatment groups Other secondary outcome measures include: 4. The proportion of resolved heel PUs at 4 months post-diagnosis of a hip fracture between treatment groups in participants with a Category =1 heel PU at their final pre-discharge/30-day in-hospital skin status measured using a bespoke patient-reported questionnaire on wound status 5. Subjective mobility status measured using the modified New Mobility Score at 4 months post-diagnosis of a hip fracture 6. Residential status measured using the UK National Hip Fracture Database Residential Status at 4 months post-diagnosis of a hip fracture 7. Mortality risk measured using death notification up to 4 months post-diagnosis of a hip fracture 8. Risk and pattern of complications measured using a bespoke complications questionnaire and routinely collected hospital data up to 4 months post-diagnosis of a hip fracture 9. Resource use from an NHS and personal social services perspective calculated using a bespoke resource use questionnaire up to 4 months post-diagnosis of a hip fracture 10. Comparative cost-effectiveness of the trial treatments using resource-use questionnaires and EQ-5D-5L up to 4 months post-diagnosis of a hip fracture	—

Measure

Time frame

Skin status assessment as described for the primary outcome measure will also be used to: 1. Compare the incidence of new Category 1 heel PUs from diagnosis of a hip fracture to index hospital discharge or 30 days whichever is soonest between treatment groups in participants with normal or Category A skin status on the heel(s) at randomisation 2. Compare the overall incidence of new Category =1 heel PUs from diagnosis of a hip fracture to index hospital discharge or 30 days whichever is soonest between treatment groups in participants with normal or Category A skin status on the heel(s) at randomisation 3. Compare the progression of Category =1 heel PUs to a higher Category from diagnosis of a hip fracture to index hospital discharge or 30 days whichever is soonest between treatment groups Other secondary outcome measures include: 4. The proportion of resolved heel PUs at 4 months post-diagnosis of a hip fracture between treatment groups in participants with a Category =1 heel PU at their final pre-discharge/30-day in-hospital skin status measured using a bespoke patient-reported questionnaire on wound status 5. Subjective mobility status measured using the modified New Mobility Score at 4 months post-diagnosis of a hip fracture 6. Residential status measured using the UK National Hip Fracture Database Residential Status at 4 months post-diagnosis of a hip fracture 7. Mortality risk measured using death notification up to 4 months post-diagnosis of a hip fracture 8. Risk and pattern of complications measured using a bespoke complications questionnaire and routinely collected hospital data up to 4 months post-diagnosis of a hip fracture 9. Resource use from an NHS and personal social services perspective calculated using a bespoke resource use questionnaire up to 4 months post-diagnosis of a hip fracture 10. Comparative cost-effectiveness of the trial treatments using resource-use questionnaires and EQ-5D-5L up to 4 months post-diagnosis of a hip fracture

—

Countries

England, United Kingdom

Contacts

Public ContactKate Herbert

White14-pressure3@ndorms.ox.ac.ukNone available

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 21, 2026