Pressure Ulcer (PU)NCT07763106
Effectiveness and Costs of Pressure Ulcer Treatment and the Quality of Life of Patients With Pressure Ulcers Receiving Home-Based and Institutional Care
A study testing residential home care treatment and long-term care treatment in people with Pressure Ulcer (PU) and Pressure Ulcers, Bedsores, Decubitus Ulcer, run by The Jerzy Kukuczka Academy of Physical Education in Katowice at 3 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Pressure Ulcer (PU), Pressure Ulcers, Bedsores, Decubitus Ulcer, Quality of Life
- What is being tested?
- residential home care treatment and long-term care treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesPoland
- Study dates
- 1 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 12Show fewer
- multiple pressure ulcers (>2),
- malignant tumors,
- decompensated diabetes,
- end-stage chronic heart failure,
- end-stage renal disease,
- mental illness.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland3 sites
Department of Clinical Physiotherapy, Jerzy Kukuczka Academy of Physical Education in Katowice, 72A Mikolowska Street
Katowice, Silesian Voivodeship, 40-065
Anna Polak, Prof., 0322075301, a.polak@awf.katowice.pl
Anna Polak, Prof.
LASERPOLAK, 92 Slowackiego Street, Myszkow
Katowice, Silesian Voivodeship, 42-300
Anna Polak, Prof., + 48 608519262, polanna@op.pl
Anna Polak, Prof.
Salus Care Center, 12 Jastrzebska Street
Rybnik, Silesian Voivodeship, 44-200
Violetta Dytko, MSc, + 48 601873608, centrumopiekisalus@gmail.com
Violetta Dytko, MSc
About this study
Official title: Comparative Assessment of the Effectiveness and Costs of Pressure Ulcer Treatment and the Quality of Life of Patients With Pressure Ulcers Receiving Home-Based and Institutional Care
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.
Read more
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.
Read the detailed description
The aim of the study is to evaluate and compare the effectiveness and costs of pressure ulcer treatment and the quality of life of patients with pressure ulcers receiving home and institutional care.
The study will include 80 patients with stage II-IV pressure ulcers, including:
- 40 patients residing in long-term care facilities (nursing and treatment facilities);
- 40 patients residing in their homes and receiving outpatient care.
Scope of care and nursing procedures for home care:
As part of home care, patients will receive regular nursing visits conducted on average four times a week, with the frequency adjustable - including on weekends and holidays - depending on the patient's health status and individual needs.
Nurses will provide services according to an individualized care plan developed based on an assessment of the patient's health status, level of independence, and home conditions.
Care will include, among other things, measuring vital signs, changing dressings, treating chronic wounds, administering medications (including injections), inserting catheters, and preventing pressure ulcers and complications resulting from limited mobility. Particular emphasis will be placed on health education for both patients and their caregivers - regarding self-care, self-care, and safe and effective functioning at home. The nurse will also serve as a coordinator, monitoring the patient's condition and, if necessary, informing the physician or other medical services about the need for additional interventions. The goal of home care is to improve the patient's quality of life, maintaining their health and functioning in the familiar and safe environment of home.
Scope of care and nursing procedures in long-term care facilities:
Patients residing in long-term care facilities will receive 24-hour nursing care provided by qualified personnel. This care will be implemented in accordance with an individualized care plan developed based on the patient's current health and functional needs. Daily nursing care, general condition monitoring, symptom monitoring, and support with basic activities of daily living such as hygiene, nutrition, and mobility will be provided. Nurses will also monitor medication intake and manage and supervise the prevention of complications related to immobilization (including pressure ulcers). Nursing care will also include health education for patients and, where possible, their families and caregivers. This care aims to maintain independence, improve quality of life, and support active participation in the treatment process.
Pressure ulcer prevention and treatment methods:
Proceedings will be in accordance with medical recommendations and best clinical practices.
This will include: pressure ulcer risk assessment, body positioning, skin care, appropriate dressings, pain and infection management, and nutritional and rehabilitation support.
- Conditions
- Pressure Ulcer (PU), Pressure Ulcers, Bedsores, Decubitus Ulcer, Quality of Life, INSTITUTIONAL CARE, Wound Closure, Wound Care
- Being tested
- residential home care treatment, long-term care treatment
- Keywords
- Pressure Ulcer, Quality of life, Home-Based, Institutional Care, wound care, wound closure, wound treatment
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
residential home care treatmentBehavioural
residential home care treatment
long-term care treatmentBehavioural
long-term care treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: residential home care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Form enrolment for every two weeks to the end of the study at 12 weeks
Secondary outcomes (2)
NSNS Scale
Newcastle Satisfaction with Nursing Scale (NSNS) - a validated instrument used to evaluate patients' experiences of and satisfaction with the quality of nursing care received during hospitalization or other healthcare services.
NSNS is used in clinical studies on the quality of nursing care in various medical facilities. It allows for the assessment of patient satisfaction with nursing care and fits perfectly with the study's objective, which concerns pressure ulcer management, where daily care, dressing changes, pressure ulcer prevention, and interpersonal relationships with staff are key. It can be used in both home care and inpatient settings.
The questionnaire uses clear and straightforward language, making it suitable for older adults.
Transformed scores on both subscales range from a minimum of 0 to a maximum of 100, where higher scores mean a better outcome.
Assessment will be conducted before the start of the study and then after 6 and 12 weeks of the study (end of the study).
Measured: 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
In long-term care, the following costs will be taken into account primarily:
- Personnel costs (nursing, care, and rehabilitation services).
- Basic medical supplies and standard dressings (e.g., gauze, bandages, sterile compresses).
- Medications from the reimbursement list.
- Patient meals and accommodations.
In home care (long-term nursing home care), the following costs will be taken into account primarily:
- Community nurse visits (nursing services costs).
- Basic dressings and medical supplies costs.
- Nursing procedures (dressing changes, measurements, patient and family education).
In both types of care, the following will also be taken into account:
- Costs of specialized dressings and care products.
- Transport costs for a home care nurse
- Rental costs of pressure-relief equipment (e.g., alternating pressure mattresses).
- Working time of non-medical caregivers.
- Additional diagnostics and specialist consultations.
The costs will be added up and calculated.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure Ulcer (PU)Studies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Jerzy Kukuczka Academy of Physical Education in Katowice
- Sponsor type
- University, hospital or other
- Collaborators
- Salus Care Center, Rybnik, Poland
- Responsible party
- Principal investigator, Laura Piejko, The Jerzy Kukuczka Academy of Physical Education in Katowice
- Investigators
- Anna Polak, Prof., Principal investigator, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763106
- Sponsor's protocol ID
- Resolution no. 11-VI/2025
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Assessment of the Effectiveness and Costs of Pressure Ulcer Treatment and the Quality of Life of Patients With Pressure Ulcers Receiving Home-Based and Institutional Care
- ClinicalTrials.gov ID
- NCT07763106
- Acronym / sponsor ID
- Resolution no. 11-VI/2025
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Jerzy Kukuczka Academy of Physical Education in KatowiceUniversity, hospital or other
- Collaborators
- Salus Care Center, Rybnik, Poland
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Aug 2026 (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.
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.
Detailed description
The aim of the study is to evaluate and compare the effectiveness and costs of pressure ulcer treatment and the quality of life of patients with pressure ulcers receiving home and institutional care.
The study will include 80 patients with stage II-IV pressure ulcers, including:
- 40 patients residing in long-term care facilities (nursing and treatment facilities);
- 40 patients residing in their homes and receiving outpatient care.
Scope of care and nursing procedures for home care:
As part of home care, patients will receive regular nursing visits conducted on average four times a week, with the frequency adjustable - including on weekends and holidays - depending on the patient's health status and individual needs.
Nurses will provide services according to an individualized care plan developed based on an assessment of the patient's health status, level of independence, and home conditions.
Care will include, among other things, measuring vital signs, changing dressings, treating chronic wounds, administering medications (including injections), inserting catheters, and preventing pressure ulcers and complications resulting from limited mobility. Particular emphasis will be placed on health education for both patients and their caregivers - regarding self-care, self-care, and safe and effective functioning at home. The nurse will also serve as a coordinator, monitoring the patient's condition and, if necessary, informing the physician or other medical services about the need for additional interventions. The goal of home care is to improve the patient's quality of life, maintaining their health and functioning in the familiar and safe environment of home.
Scope of care and nursing procedures in long-term care facilities:
Patients residing in long-term care facilities will receive 24-hour nursing care provided by qualified personnel. This care will be implemented in accordance with an individualized care plan developed based on the patient's current health and functional needs. Daily nursing care, general condition monitoring, symptom monitoring, and support with basic activities of daily living such as hygiene, nutrition, and mobility will be provided. Nurses will also monitor medication intake and manage and supervise the prevention of complications related to immobilization (including pressure ulcers). Nursing care will also include health education for patients and, where possible, their families and caregivers. This care aims to maintain independence, improve quality of life, and support active participation in the treatment process.
Pressure ulcer prevention and treatment methods:
Proceedings will be in accordance with medical recommendations and best clinical practices.
This will include: pressure ulcer risk assessment, body positioning, skin care, appropriate dressings, pain and infection management, and nutritional and rehabilitation support.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GE-1 | Experimental | Behavioral: long-term care treatmentExperimental 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. |
| GE-2 | Experimental | Behavioral: residential home care treatmentExperimental 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. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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,
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 |
|---|---|---|
| residential home care treatmentresidential home care treatment | Behavioural | GE-2 |
| long-term care treatmentlong-term care treatment | Behavioural | GE-1 |
Primary outcome
Quality of Life Questionnaire Assessment - EQ-5D-5L Scale
Time frame: From enrollment, during the study at 6 week and at the end of the study at 12 weeks
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).
Planimetry
Time frame: Form enrolment for every two weeks to the end of the study at 12 weeks
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.
2 secondary outcomes
NSNS Scale
Time frame: 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
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
Anna Polak, Prof. principal investigator
The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing residential home care treatment and long-term care treatment in people with Pressure Ulcer (PU) and Pressure Ulcers, Bedsores, Decubitus Ulcer, run by The Jerzy Kukuczka Academy of Physical Education in Katowice at 3 sites in Poland.
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 5 inclusion and 12 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: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Polak, Prof. (+ 48 0322075301, a.polak@awf.katowice.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Questionnaire Assessment - EQ-5D-5L Scale (time frame: From enrollment, during the study at 6 week and at the end of the study at 12 weeks). The study lists 2 primary outcomes in all. 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 13 Aug 2026.