Linköping University
Linköping, 58183, Sweden
Location contact
Sara Bergstrand, PhD
PRINCIPAL_INVESTIGATOR
Not Yet Recruiting
NCT Number: NCT06468306
Combined Molecular and Mechanistic Methods for Detection of Pressure Ulcers
This project aims to develop a novel method for identifying early tissue damage related to pressure ulcer (PU) development in vulnerable patients by measuring biomarkers of inflammation on the skin surface. PUs are common and costly injuries that result from prolonged pressure on the skin. Current methods to assess PU risk are unreliable, and the mechanisms of PU development are not well understood. This project contributes to new knowledge of PU etiology as well as the individual variability at a molecular level combined with new knowledge about nursing actions and clinical factors linked to PU progression and outcomes of prevention. The project will use non-invasive techniques and model-based analysis to identify specific biomolecules that reflect individual susceptibility to pressure exposure in different PU risk scenarios.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
Purpose and aims A pressure ulcer (PU) is a localized injury to the skin and/or underlying tissue and develop from prolonged pressure on the skin. Such injuries are common in the healthcare setting, especially among vulnerable elderly. PUs greatly decrease the quality of life of individuals and are costly for the healthcare system. As many as 14% of the inpatients suffered from PUs in the Swedish country's municipalities and regions during 2022. The origin and timing of events leading to PUs are not fully understood, and current methods to assess the risk for an individual to develop a PU, are unreliable. Therefore, there is an urgent need to develop more objective, sensitive and specific methods for identifying early signs of tissue damage before they come visible and thus avoid development of PUs.
The investigators have previously identified a preliminary set of molecular biomarkers (cytokines and proteins), sampled non-invasively in the sebum, that reflects the inflammatory process under-pinning PU etiology and, possibly, individual susceptibility to pressure exposure. Therefore, it is hypothesize that non-invasive measurements of specific biomolecules on the skin surface, together with model-based analysis, can be used for individualized PU prediction. Accordingly, the purpose of this project is to confirm and expand on these preliminary findings in different PU risk scenarios to model the underlying inflammatory processes that reflect the individual vulnerability of the skin caused by pressure exposure and use modeling to extract a new layer of mechanistic insights of the underlying inflammatory process in different patient populations.
The specific aims of the project are:
- To establish and validate optimal combinations of molecular biomarkers to identify individual susceptibility to pressure exposure during routine management regimes related to medical devises non-invasive ventilation (NIV) therapy.
- To unravel key mechanisms in inflammatory processes related to early tissue damage by developing a mathematical model for the timing of events in the response to pressure, based on collected biomolecules, earlier data, and interaction databases
- To identify risk factors of PU vulnerability on an individual level in routine clinical settings by combining biomolecules, model-based simulations, and clinical parameters
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- patients that use oronasal face masks in their ordinary care during routine management regimes of non invasive ventilation.
Exclusion criteria
- acute respiratory failure
- previous ICU care
- pressure ulcer on measurement site
Treatment and study plan
non-invasive ventilation teraphy, NIV
ProcedureRoutine management regimes of NIV
Primary outcomes
-
CTACK
Time frame: 2 minutes
inflammatory biomarker
-
ENA-78
Time frame: 2 minutes
inflammatory biomarker
-
Eotaxin
Time frame: 2 minutes
inflammatory biomarker
-
Eotaxin-2
Time frame: 2 minutes
inflammatory biomarker
-
Eotaxin-3
Time frame: 2 minutes
inflammatory biomarker
-
EPO
Time frame: 2 minutes
inflammatory biomarker
-
FLT3L
Time frame: 2 minutes
inflammatory biomarker
-
Fractalkine
Time frame: 2 minutes
inflammatory biomarker
-
G-CSF
Time frame: 2 minutes
inflammatory biomarker
-
GM-CSF
Time frame: 2 minutes
inflammatory biomarker
-
GRO-alpha
Time frame: 2 minutes
inflammatory biomarker
-
I-309
Time frame: 2 minutes
inflammatory biomarker
-
IFN-α2a
Time frame: 2 minutes
inflammatory biomarker
-
IFN-β
Time frame: 2 minutes
inflammatory biomarker
-
IFN-γ
Time frame: 2 minutes
inflammatory biomarker
-
IL-10
Time frame: 2 minutes
inflammatory biomarker
-
IL-12/IL-23p40
Time frame: 2 minutes
inflammatory biomarker
-
IL-12p70
Time frame: 2 minutes
inflammatory biomarker
-
IL-13
Time frame: 2 minutes
inflammatory biomarker
-
IL-15
Time frame: 2 minutes
inflammatory biomarker
-
IL-16
Time frame: 2 minutes
inflammatory biomarker
-
IL-17A
Time frame: 2 minutes
inflammatory biomarker
-
IL-17A/F
Time frame: 2 minutes
inflammatory biomarker
-
IL-17B
Time frame: 2 minutes
inflammatory biomarker
-
IL-17C
Time frame: 2 minutes
inflammatory biomarker
-
IL-17D
Time frame: 2 minutes
inflammatory biomarker
-
IL-17E/IL-25
Time frame: 2 minutes
inflammatory biomarker
-
IL-17F
Time frame: 2 minutes
inflammatory biomarker
-
IL-18
Time frame: 2 minutes
inflammatory biomarker
-
IL-1RA
Time frame: 2 minutes
inflammatory biomarker
-
IL-1α
Time frame: 2 minutes
inflammatory biomarker
-
IL-1β
Time frame: 2 minutes
inflammatory biomarker
-
IL-2
Time frame: 2 minutes
inflammatory biomarker
-
IL-21
Time frame: 2 minutes
inflammatory biomarker
-
IL-22
Time frame: 2 minutes
inflammatory biomarker
-
IL-23
Time frame: 2 minutes
inflammatory biomarker
-
IL-27
Time frame: 2 minutes
inflammatory biomarker
-
IL-29/IFN-L1
Time frame: 2 minutes
inflammatory biomarker
-
IL-2Ra
Time frame: 2 minutes
inflammatory biomarker
-
IL-3
Time frame: 2 minutes
inflammatory biomarker
-
IL-31
Time frame: 2 minutes
inflammatory biomarker
-
IL-33
Time frame: 2 minutes
inflammatory biomarker
-
IL-4
Time frame: 2 minutes
inflammatory biomarker
-
IL-5
Time frame: 2 minutes
inflammatory biomarker
-
IL-6
Time frame: 2 minutes
inflammatory biomarker
-
IL-7
Time frame: 2 minutes
inflammatory biomarker
-
IL-8
Time frame: 2 minutes
inflammatory biomarker
-
IL-9
Time frame: 2 minutes
inflammatory biomarker
-
IP-10
Time frame: 2 minutes
inflammatory biomarker
-
I-TAC
Time frame: 2 minutes
inflammatory biomarker
-
MCP-1
Time frame: 2 minutes
inflammatory biomarker
-
MCP-2
Time frame: 2 minutes
inflammatory biomarker
-
MCP-3
Time frame: 2 minutes
inflammatory biomarker
-
MCP-4
Time frame: 2 minutes
inflammatory biomarker
-
M-CSF
Time frame: 2 minutes
inflammatory biomarker
-
MDC
Time frame: 2 minutes
inflammatory biomarker
-
MIF
Time frame: 2 minutes
inflammatory biomarker
-
MIP-1α
Time frame: 2 minutes
inflammatory biomarker
-
MIP-1β
Time frame: 2 minutes
inflammatory biomarker
-
MIP-3α
Time frame: 2 minutes
inflammatory biomarker
-
MIP-3β
Time frame: 2 minutes
inflammatory biomarker
-
MIP-5
Time frame: 2 minutes
inflammatory biomarker
-
SDF-1alpha
Time frame: 2 minutes
inflammatory biomarker
-
TARC
Time frame: 2 minutes
inflammatory biomarker
-
TNF-α
Time frame: 2 minutes
inflammatory biomarker
-
TNF-β
Time frame: 2 minutes
inflammatory biomarker
-
TPO
Time frame: 2 minutes
inflammatory biomarker
-
TRAIL
Time frame: 2 minutes
inflammatory biomarker
-
TSLP
Time frame: 2 minutes
inflammatory biomarker
-
VEGF-A
Time frame: 2 minutes
inflammatory biomarker
-
YKL-40
Time frame: 2 minutes
inflammatory biomarker
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Linkoeping University
Other Gov
Collaborators
- Region Östergötland
Registry information
Official study title
Combined Molecular and Mechanistic Methods for Early Detection and Individual Prevention of Pressure Ulcer Formation in Vulnerable Patients
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2027
- First posted
- Jun 21, 2024
- Registry last updated
- Jun 21, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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