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The Effect Of Heel Protector In Intensive Care Units (EHePIcu)

M

Maltepe University

Status

Enrolling

Conditions

Plantar Flexion Contracture of Tarsometatarsal Joint
Pressure Ulcer, Heel

Treatments

Device: Control group
Device: The Effect Of Heel Protector In Intensive Care Units

Study type

Interventional

Funder types

Other

Identifiers

NCT05436340
2021/33-20

Details and patient eligibility

About

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.

Enrollment

84 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

84 participants in 2 patient groups

EHepIcu
Experimental group
Treatment:
Device: The Effect Of Heel Protector In Intensive Care Units
Device: Control group
Control Grubs
No Intervention group

Trial contacts and locations

1

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Central trial contact

Kübra Arslan

Data sourced from clinicaltrials.gov

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