AzTrials
AzTrials

Pressure UlcerNCT06468306

Combined Molecular and Mechanistic Methods for Detection of Pressure Ulcers

An observational study of Pressure Ulcer and Inflammatory Response, run by Linkoeping University at 1 site in Sweden.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pressure Ulcer, Inflammatory Response
What is being tested?
non-invasive ventilation teraphy, NIV
Type of treatment
Surgery or procedure
How many people
150 participants
Where
1 siteSweden
Study dates
1 Aug 2024to 30 Dec 2027
Phase
Observational
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients that use oronasal face masks in their ordinary care during routine management regimes of non invasive ventilation.

Who may be able to join

  • patients that use oronasal face masks in their ordinary care during routine management regimes of non invasive ventilation.

Who cannot join

  • acute respiratory failure
  • previous ICU care
  • pressure ulcer on measurement site

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sara Bergstrand, PhD contact

+4613286773

sara.bergstrand@liu.se

Sweden1 site

  • Linköping University

    Linköping, 58183

    Sara Bergstrand, PhD

Other trials in Sweden

About this study

Official title: Combined Molecular and Mechanistic Methods for Early Detection and Individual Prevention of Pressure Ulcer Formation in Vulnerable Patients

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.

Read the detailed description

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:

  1. 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.
  2. 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
  3. To identify risk factors of PU vulnerability on an individual level in routine clinical settings by combining biomolecules, model-based simulations, and clinical parameters
Being tested
non-invasive ventilation teraphy, NIV
Keywords
Pressure Ulcer, nursing, prevention
Medical subject headings
Pressure Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • non-invasive ventilation teraphy, NIVProcedure or surgery

    Routine management regimes of NIV

Study groups in NCT06468306
Study groupRoleWhat they receive
individuals with NIV treatmentPatients that use oronasal face masks in their ordinary care to measure early-stage medical devise-related tissue damage during routine management regimes of NIV. Approximately 150 adult patients of both sexes will be recruited, from facilities that employ oronasal face masks in the routine care.
Receives: Procedure: non-invasive ventilation teraphy, NIV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CTACK

    inflammatory biomarker

    Measured: 2 minutes

  2. ENA-78

    inflammatory biomarker

    Measured: 2 minutes

  3. Eotaxin

    inflammatory biomarker

    Measured: 2 minutes

  4. Eotaxin-2

    inflammatory biomarker

    Measured: 2 minutes

  5. Eotaxin-3

    inflammatory biomarker

    Measured: 2 minutes

  6. EPO

    inflammatory biomarker

    Measured: 2 minutes

  7. FLT3L

    inflammatory biomarker

    Measured: 2 minutes

  8. Fractalkine

    inflammatory biomarker

    Measured: 2 minutes

  9. G-CSF

    inflammatory biomarker

    Measured: 2 minutes

  10. GM-CSF

    inflammatory biomarker

    Measured: 2 minutes

  11. GRO-alpha

    inflammatory biomarker

    Measured: 2 minutes

  12. I-309

    inflammatory biomarker

    Measured: 2 minutes

  13. IFN-α2a

    inflammatory biomarker

    Measured: 2 minutes

  14. IFN-β

    inflammatory biomarker

    Measured: 2 minutes

  15. IFN-γ

    inflammatory biomarker

    Measured: 2 minutes

  16. IL-10

    inflammatory biomarker

    Measured: 2 minutes

  17. IL-12/IL-23p40

    inflammatory biomarker

    Measured: 2 minutes

  18. IL-12p70

    inflammatory biomarker

    Measured: 2 minutes

  19. IL-13

    inflammatory biomarker

    Measured: 2 minutes

  20. IL-15

    inflammatory biomarker

    Measured: 2 minutes

  21. IL-16

    inflammatory biomarker

    Measured: 2 minutes

  22. IL-17A

    inflammatory biomarker

    Measured: 2 minutes

  23. IL-17A/F

    inflammatory biomarker

    Measured: 2 minutes

  24. IL-17B

    inflammatory biomarker

    Measured: 2 minutes

  25. IL-17C

    inflammatory biomarker

    Measured: 2 minutes

  26. IL-17D

    inflammatory biomarker

    Measured: 2 minutes

  27. IL-17E/IL-25

    inflammatory biomarker

    Measured: 2 minutes

  28. IL-17F

    inflammatory biomarker

    Measured: 2 minutes

  29. IL-18

    inflammatory biomarker

    Measured: 2 minutes

  30. IL-1RA

    inflammatory biomarker

    Measured: 2 minutes

  31. IL-1α

    inflammatory biomarker

    Measured: 2 minutes

  32. IL-1β

    inflammatory biomarker

    Measured: 2 minutes

  33. IL-2

    inflammatory biomarker

    Measured: 2 minutes

  34. IL-21

    inflammatory biomarker

    Measured: 2 minutes

  35. IL-22

    inflammatory biomarker

    Measured: 2 minutes

  36. IL-23

    inflammatory biomarker

    Measured: 2 minutes

  37. IL-27

    inflammatory biomarker

    Measured: 2 minutes

  38. IL-29/IFN-L1

    inflammatory biomarker

    Measured: 2 minutes

  39. IL-2Ra

    inflammatory biomarker

    Measured: 2 minutes

  40. IL-3

    inflammatory biomarker

    Measured: 2 minutes

  41. IL-31

    inflammatory biomarker

    Measured: 2 minutes

  42. IL-33

    inflammatory biomarker

    Measured: 2 minutes

  43. IL-4

    inflammatory biomarker

    Measured: 2 minutes

  44. IL-5

    inflammatory biomarker

    Measured: 2 minutes

  45. IL-6

    inflammatory biomarker

    Measured: 2 minutes

  46. IL-7

    inflammatory biomarker

    Measured: 2 minutes

  47. IL-8

    inflammatory biomarker

    Measured: 2 minutes

  48. IL-9

    inflammatory biomarker

    Measured: 2 minutes

  49. IP-10

    inflammatory biomarker

    Measured: 2 minutes

  50. I-TAC

    inflammatory biomarker

    Measured: 2 minutes

  51. MCP-1

    inflammatory biomarker

    Measured: 2 minutes

  52. MCP-2

    inflammatory biomarker

    Measured: 2 minutes

  53. MCP-3

    inflammatory biomarker

    Measured: 2 minutes

  54. MCP-4

    inflammatory biomarker

    Measured: 2 minutes

  55. M-CSF

    inflammatory biomarker

    Measured: 2 minutes

  56. MDC

    inflammatory biomarker

    Measured: 2 minutes

  57. MIF

    inflammatory biomarker

    Measured: 2 minutes

  58. MIP-1α

    inflammatory biomarker

    Measured: 2 minutes

  59. MIP-1β

    inflammatory biomarker

    Measured: 2 minutes

  60. MIP-3α

    inflammatory biomarker

    Measured: 2 minutes

  61. MIP-3β

    inflammatory biomarker

    Measured: 2 minutes

  62. MIP-5

    inflammatory biomarker

    Measured: 2 minutes

  63. SDF-1alpha

    inflammatory biomarker

    Measured: 2 minutes

  64. TARC

    inflammatory biomarker

    Measured: 2 minutes

  65. TNF-α

    inflammatory biomarker

    Measured: 2 minutes

  66. TNF-β

    inflammatory biomarker

    Measured: 2 minutes

  67. TPO

    inflammatory biomarker

    Measured: 2 minutes

  68. TRAIL

    inflammatory biomarker

    Measured: 2 minutes

  69. TSLP

    inflammatory biomarker

    Measured: 2 minutes

  70. VEGF-A

    inflammatory biomarker

    Measured: 2 minutes

  71. YKL-40

    inflammatory biomarker

    Measured: 2 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2024
  2. Study start1 Aug 2024 (estimated)
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06468306
Sponsor's protocol ID
2023-07341-01
Other IDs
2023
Status last verified
Jun 2024
First submitted
4 Jun 2024
Last updated
21 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IDP data will be shared outside the research group

Publications

  • Kallman U, Bergstrand S, Ek AC, Engstrom M, Lindgren M. Blood flow responses over sacrum in nursing home residents during one hour bed rest. Microcirculation. 2016 Oct;23(7):530-539. doi: 10.1111/micc.12303.

    PubMed 27534925

  • Feldt A, Kohler AK, Bergstrand S. Nurses' strategies to enable continuous positive airway pressure therapy in a general medical ward context: A qualitative study. Scand J Caring Sci. 2023 Jun;37(2):524-533. doi: 10.1111/scs.13136. Epub 2022 Nov 28.

    PubMed 36440591

  • John AJUK, Galdo FD, Gush R, Worsley PR. An evaluation of mechanical and biophysical skin parameters at different body locations. Skin Res Technol. 2023 Feb;29(2):e13292. doi: 10.1111/srt.13292.

    PubMed 36823505

  • Jayabal H, Bader DL, Worsley P. Development of an Efficient Extraction Methodology to Analyse Potential Inflammatory Biomarkers from Sebum. Skin Pharmacol Physiol. 2023;36(1):38-50. doi: 10.1159/000528653. Epub 2022 Dec 26.

    PubMed 36572004

Questions about this trial

What is this clinical trial studying?

An observational study of Pressure Ulcer and Inflammatory Response, run by Linkoeping University at 1 site in Sweden.

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 1 inclusion and 3 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 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. 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 Sara Bergstrand, PhD (+4613286773, sara.bergstrand@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CTACK (time frame: 2 minutes). The study lists 71 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06468306, which also lists 4 linked publications.

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 21 Jun 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in