The Effect Of Heel Protector In Intensive Care Units

NCT ID: NCT05436340

Last Updated: 2022-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pressure Ulcer, Heel Plantar Flexion Contracture of Tarsometatarsal Joint

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EHepIcu

Group Type EXPERIMENTAL

The Effect Of Heel Protector In Intensive Care Units

Intervention Type DEVICE

In the experimental group, foot joint opening and heel pressure sore formation will be observed by using heel protector pad.

Control group

Intervention Type DEVICE

Heel pads will not be used in the control group. Routine maintenance will be applied

Control Grubs

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

The Effect Of Heel Protector In Intensive Care Units

In the experimental group, foot joint opening and heel pressure sore formation will be observed by using heel protector pad.

Intervention Type DEVICE

Control group

Heel pads will not be used in the control group. Routine maintenance will be applied

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Maltepe University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kübra Arslan

Master's Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sebahat Ateş

Role: STUDY_DIRECTOR

Üsküdar Üniversitesi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kübra Arslan

Kocaeli, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kübra Arslan

Role: CONTACT

05549112925

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kübra Arslan

Role: primary

05549112925

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021/33-20

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Effect of Insoles in Plantar Fasciitis
NCT06563492 NOT_YET_RECRUITING NA
Heel Cushion for Plantar Fasciitis
NCT01017406 UNKNOWN PHASE3
Evidence-Based Orthotics Prosthetics Practices
NCT06175364 NOT_YET_RECRUITING NA