Effectiveness and Costs of Pressure Ulcer Treatment and the Quality of Life of Patients With Pressure Ulcers Receiving Home-Based and Institutional Care
Pressure Ulcer (PU)Pressure Ulcers, Bedsores, Decubitus UlcerQuality of LifeINSTITUTIONAL CAREWound ClosureWound Care
Investigational drug(s) / intervention(s)
residential home care treatmentlong-term care treatment
residential home care treatment: residential home care treatment
long-term care treatment: long-term care treatment
Study 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.
Eligibility
Sex
ALL
Min age
60 Years
Max age
90 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Quality of Life Questionnaire Assessment - EQ-5D-5L Scale — 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 — 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.
Trial sites (3)
Facility
City
Region
Status
Department of Clinical Physiotherapy, Jerzy Kukuczka Academy of Physical Education in Katowice, 72A Mikolowska Street
Katowice
Silesian Voivodeship
LASERPOLAK, 92 Slowackiego Street, Myszkow
Katowice
Silesian Voivodeship
Salus Care Center, 12 Jastrzebska Street
Rybnik
Silesian Voivodeship
More The Jerzy Kukuczka Academy of Physical Education in Katowice trials in Poland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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