Pressure Ulcer, HeelEHePIcuNCT05436340
The Effect Of Heel Protector In Intensive Care Units
A study testing The Effect Of Heel Protector In Intensive Care Units in people with Pressure Ulcer, Heel and Plantar Flexion Contracture of Tarsometatarsal Joint, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: It was aimed to evaluate the effectiveness of using heel protector products for the prevention of heel pressure sore and plantar flexion contracture in patients hospitalized in intensive care units for a long time. Design: The study is conducted as a Randomized Controlled Study. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer, Heel, Plantar Flexion Contracture of Tarsometatarsal Joint
- What is being tested?
- The Effect Of Heel Protector In Intensive Care Units
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- High-risk patients; patients who were intubated or extubated in the ICU for at least 5 days and received sedation
- Patients with Braden Pressure Sore Risk Assessment Scale 16 and below
- Patients with a Ramsey Sedation Scale of 4 and above
Who cannot join
- BMI over 30
- Patients with vascular disease
- Patients with albumin level below 2.5 mg/dL
- Patients mobile within 5 days
- Patients hospitalized with heel pressure ulcer
- Despite being included in the study, the patient becomes mobile before 15 days
- Patients with a medical condition that contraindicates the use of heel protectors
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kübra Arslan
Kocaeli
Kübra Arslan, 05549112925, arslankbraa@gmail.com
About this study
Official title: THE EFFECT OF THE USE OF HEEL PROTECTORS ON THE PREVENTION OF HEEL PRESSURE SORES AND PLANTAR FLEXION CONTRACTURES IN INTENSIVE CARE UNITS
Purpose: It was aimed to evaluate the effectiveness of using heel protector products for the prevention of heel pressure sore and plantar flexion contracture in patients hospitalized in intensive care units for a long time.
Design: The study is conducted as a Randomized Controlled Study. Method: Heel protectors will be used in the intervention group among the patients in the intensive care unit who meet the inclusion criteria of the study, and the control group will be positioned with a pillow, which is the standard practice. As calculated in the G-Power program with reference to the source, a total of 42 patients were determined to be included in the intervention group and 42 patients in the control group. These patients will be followed for a total of 14 days. Heel Scalp Evaluation and Goniometric Measurements will be made according to Braden Pressure Wound Risk Assessment Scale, Ramsey Sedation Scale, NPUAP and EPUAP Staging System and recorded in the data collection form created by the researcher.
Read more
H1: The heel protector is effective in preventing heel pressure ulcer. H0: The heel protector has no effect on preventing heel pressure ulcer. H2: The heel protector is effective in preventing plantar flexion contracture. H0: The heel protector has no effect on preventing plantar flexion contracture. H3: The heel protector is effective in improving the joint range of patients with plantar flexion contracture.
H0: The heel protector has no effect on improving joint range in patients with plantar flexion contracture.
- Being tested
- The Effect Of Heel Protector In Intensive Care Units, Control group
- Keywords
- Heel Pressure Ulcer, Plantar Flexion Contracture, Heel Protector
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Effect Of Heel Protector In Intensive Care UnitsDevice
In the experimental group, foot joint opening and heel pressure sore formation will be observed by using heel protector pad.
Control groupDevice
Heel pads will not be used in the control group. Routine maintenance will be applied
| Study group | Role | What they receive |
|---|---|---|
| EHepIcu | Experimental | Not described Receives: Device: The Effect Of Heel Protector In Intensive Care Units; Device: Control group |
| Control Grubs | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Joint Opening
goniometric measurement by the researcher
Measured: for 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Feb 2022
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure Ulcer, HeelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Arslan, Maltepe University
- Investigators
- Sebahat Ateş, Study director, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436340
- Sponsor's protocol ID
- 2021/33-20
- Acronym
- EHePIcu
- Status last verified
- Oct 2022
- First submitted
- 23 Jun 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF THE USE OF HEEL PROTECTORS ON THE PREVENTION OF HEEL PRESSURE SORES AND PLANTAR FLEXION CONTRACTURES IN INTENSIVE CARE UNITS
- ClinicalTrials.gov ID
- NCT05436340
- Acronym / sponsor ID
- EHePIcu / 2021/33-20
- Keywords
- Heel Pressure Ulcer, Plantar Flexion Contracture, Heel Protector
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: It was aimed to evaluate the effectiveness of using heel protector products for the prevention of heel pressure sore and plantar flexion contracture in patients hospitalized in intensive care units for a long time.
Design: The study is conducted as a Randomized Controlled Study. Method: Heel protectors will be used in the intervention group among the patients in the intensive care unit who meet the inclusion criteria of the study, and the control group will be positioned with a pillow, which is the standard practice. As calculated in the G-Power program with reference to the source, a total of 42 patients were determined to be included in the intervention group and 42 patients in the control group. These patients will be followed for a total of 14 days. Heel Scalp Evaluation and Goniometric Measurements will be made according to Braden Pressure Wound Risk Assessment Scale, Ramsey Sedation Scale, NPUAP and EPUAP Staging System and recorded in the data collection form created by the researcher.
H1: The heel protector is effective in preventing heel pressure ulcer. H0: The heel protector has no effect on preventing heel pressure ulcer. H2: The heel protector is effective in preventing plantar flexion contracture. H0: The heel protector has no effect on preventing plantar flexion contracture. H3: The heel protector is effective in improving the joint range of patients with plantar flexion contracture.
H0: The heel protector has no effect on improving joint range in patients with plantar flexion contracture.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EHepIcu | Experimental | Device: The Effect Of Heel Protector In Intensive Care Units, Device: Control group |
| Control Grubs | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- High-risk patients; patients who were intubated or extubated in the ICU for at least 5 days and received sedation
- Patients with Braden Pressure Sore Risk Assessment Scale 16 and below
- Patients with a Ramsey Sedation Scale of 4 and above
Key exclusion criteria (7 listed)
- BMI over 30
- Patients with vascular disease
- Patients with albumin level below 2.5 mg/dL
- Patients mobile within 5 days
- Patients hospitalized with heel pressure ulcer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Effect Of Heel Protector In Intensive Care UnitsIn the experimental group, foot joint opening and heel pressure sore formation will be observed by using heel protector pad. | Device | EHepIcu |
| Control groupHeel pads will not be used in the control group. Routine maintenance will be applied | Device | EHepIcu |
Primary outcome
Foot Joint Opening
Time frame: for 14 days
goniometric measurement by the researcher
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
Related trials for Pressure Ulcer, Heel
Enrolling by invitationObservational study
Evaluation of Commercially Available Heel Pads for the Prevention of Pressure Ulcers: An Observational Study of Incidence and Usability in Adult Surgical Patients.
Pressure Injury Prevention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebahat Ateş study director
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Effect Of Heel Protector In Intensive Care Units in people with Pressure Ulcer, Heel and Plantar Flexion Contracture of Tarsometatarsal Joint, run by Maltepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kübra Arslan (05549112925, arslankbraa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot Joint Opening (time frame: for 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.