Effectiveness and Costs of Pressure Ulcer Treatment and the Quality of Life of Patients With Pressure Ulcers Receiving Home-Based and Institutional Care

NCT07763106 | Not Yet Recruiting

• 1 other identifier: Resolution no. 11-VI/2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

A study aimed at comparing the effectiveness of treatment, costs, and quality of life of patients with pressure ulcers in home care and institutional care. Eighty individuals aged 60-90 years with stage II-IV pressure ulcers can participate in the study. Participants will be assessed for factors such as health status, independence, mood, and quality of life. The study will allow for better tailoring care to patients' needs. Other benefits of participating in the study is that the participants will receive a detailed assessment of their health, nutrition, quality of life, as well as support in managing their pressure ulcers. They will receive regular care and medical evaluations, which may positively impact their health and well-being. Refusing to participate in this study will not affect the patients treatment in any way. Please ask if there is anything that is unclear or if you would like additional information. Taking part in this study is entirely voluntary.

Conditions

Pressure Ulcer (PU); Pressure Ulcers, Bedsores, Decubitus Ulcer; Quality of Life; INSTITUTIONAL CARE; Wound Closure; Wound Care

Keywords

Pressure Ulcer; Quality of life; Home-Based; Institutional Care; wound care; wound closure; wound treatment

Outcome Measures

Primary Outcomes (2)

• Quality of Life Questionnaire Assessment - EQ-5D-5L Scale

  Quality of Life Questionnaire assessment will be conducted using the EQ-5D-5L - a standardized generic instrument for measuring health-related quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, together with a self-rated health visual analogue scale (EQ VAS) or QOL-AD (Quality of Life in Alzheimer's Disease) - a validated questionnaire designed to assess quality of life in individuals with dementia. The questionnaire will be presented in a version for the patient and a caregiver. The index scores range from roughly -0.59 to 1 (higher = better outcome), and EQ VAS scores range from 0 to 100 (higher = better health) Assessment will be conducted before the start of the study and then after 6 and 12 weeks of the study (the end of the study).

  From enrollment, during the study at 6 week and at the end of the study at 12 weeks

• Planimetry

  Planimetry - a quantitative method used to measure the surface area of pressure ulcers (cm²) to monitor wound healing over time. Measurements will be performed every two weeks. If the pressure ulcer heals before the end of the 12th week, the date of healing will be recorded in the documentation. The surface area of the pressure ulcer will be measured using planimetry. First, a waterproof marker will be used to trace the contours of the pressure ulcer on a transparent, soft, non-stretchable film, which will be placed directly on the pressure ulcer after disinfection. Next, the contour of the pressure ulcer will be transferred to a transparent, rigid film, and the surface area of the defect will be measured using a planimeter (Mutoh Kurta XGT, Altek, USA). The planimeter will be connected to a computer equipped with special C-GEO software (version 4.0, Nadowski SoftLine, PL), which allows for the calculation of pressure ulcer surface area and data storage.

  Form enrolment for every two weeks to the end of the study at 12 weeks

Secondary Outcomes (2)

• NSNS Scale

  From enrollment, during the study at 6 week and to the end of the study at 12 weeks

• Costs of pressure ulcer prevention and treatment assessment

  From enrollment to the end of treatment at 12 weeks

Other Outcomes (7)

• NPIAP/EPUAP Classification System

  At / upon enrollment

• MNA assessment

  At / upon enrollment

• GDS-30 Scale

  At / upon enrollment

Study Arms (2)

GE-1

EXPERIMENTAL

Experimental group 1 (GE1), in which 40 patients will be treated in long-term care facilities The study will be conducted for 12 weeks. The following will be assessed: * Effectiveness of pressure ulcer treatment based on changes in pressure ulcer surface area. * Patient quality of life and satisfaction with nursing care. * Costs of pressure ulcer prevention and treatment.

Behavioral: long-term care treatment

GE-2

EXPERIMENTAL

Experimental Group 2 (GE2), in which 40 patients will be treated in residential home care facilities The study will be conducted for 12 weeks. The following will be assessed: * Effectiveness of pressure ulcer treatment based on changes in pressure ulcer surface area. * Patient quality of life and satisfaction with nursing care. * Costs of pressure ulcer prevention and treatment.

Behavioral: residential home care treatment

Interventions

residential home care treatment BEHAVIORAL

residential home care treatment

GE-2

long-term care treatment BEHAVIORAL

long-term care treatment

GE-1

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women and men aged 60 to 90 years,
• stage II-IV pressure ulcers in the lumbar-sacral area of the trunk, pelvic girdle, and lower limbs,
• high risk of pressure ulcers (above 15 points on the Waterlow scale),
• daily functional ability below 40 points on the Barthel scale,
• consent from the patient or legal guardian/caregiver to participate in the study.

You may not qualify if:

• General contraindications (acute inflammatory conditions and febrile illnesses, venous thrombosis, cachexia),
• pressure ulcers requiring surgical treatment (black necrosis, inflammation of bones and soft tissues),
• tunneling pressure ulcers showing signs of acute inflammation,
• pressure ulcers showing signs of infection (causing fever, swelling, pain, and unpleasant odor),
• pressure ulcers with a surface area of less than 0.5 cm2,
• pressure ulcers occurring on the lower legs or feet in patients with acute and chronic venous insufficiency and diabetes,
• multiple pressure ulcers (\>2),
• malignant tumors,
• decompensated diabetes,
• end-stage chronic heart failure,
• end-stage renal disease,
• mental illness.

Sponsors & Collaborators

• The Jerzy Kukuczka Academy of Physical Education in Katowice: lead
• Salus Care Center, Rybnik, Poland: collaborator

Study Sites (3)

Department of Clinical Physiotherapy, Jerzy Kukuczka Academy of Physical Education in Katowice, 72A Mikolowska Street

Katowice, Silesian Voivodeship, 40-065, Poland

Location

LASERPOLAK, 92 Slowackiego Street, Myszkow

Katowice, Silesian Voivodeship, 42-300, Poland

Location

Salus Care Center, 12 Jastrzebska Street

Rybnik, Silesian Voivodeship, 44-200, Poland

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Anna Polak, Prof.

  The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Polak, Prof.

CONTACT

+ 48 0322075301; a.polak@awf.katowice.pl

Laura Piejko, PT, PhD

CONTACT

0322075310; l.piejko@awf.katowice.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 13, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-08

Locations

PL (3)