Not Yet RecruitingNot Applicable

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

Poland80 participantsStarted 2026-09-01

Plain-language 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.

Who can participate

Age range

60 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Planimetry

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

Trial details

NCT IDNCT07763106

SponsorThe Jerzy Kukuczka Academy of Physical Education in Katowice

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-30

Contact for this trial

Anna Polak, Prof.

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

View on ClinicalTrials.gov More Pressure Ulcer (PU) trials