Investigation of the Effect of Blood Pressure on Bedsores | NCT07696416

Studies
Investigation of the Effect of Blood Pressure on Bedsores

NCT07696416

Sponsor

Yuzuncu Yil University

Status

Not yet recruiting

Last Update Posted

Jul 10, 2026Actual

Enrollment

148Estimated

Phase

Not provided

Conditions

Decubitus Ulcer

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2026Estimated

Primary Completion Date

Nov 20, 2026Estimated

Completion Date

Nov 20, 2026Estimated

First Submitted Date

Jun 24, 2026

First Submission Date that Met QC Criteria

Jul 9, 2026

First Posted Date

Jul 10, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2026

Last Update Posted Date

Jul 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

The aim of this study is to comprehensively investigate the effect of blood pressure levels on the development of bedsores (pressure ulcers) in adult patients hospitalized in the internal medicine intensive care unit. In intensive care patients, several factors, such as prolonged immobility, decreased level of consciousness, circulatory disorders, and hemodynamic instability, increase the risk of bedsore formation. This study specifically aims to evaluate the effects of systemic blood pressure changes-such as hypotension or hypertension-on skin integrity and to determine the contribution of these effects to the development of bedsores.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

148Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intensive care patients		The development and timing of bedsores in patients will be recorded. Vital signs will also be monitored.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Decubitus Ulcer	Pressure ulcers will be assessed using the Norton Pressure Ulcer Scale Daily Rating.	For 10 days

Secondary Outcomes

Measure	Description	Time Frame
Vital signs - Blood pressure measurements (SBP, DBP)	Blood pressure measurements (SBP, DBP)	For 10 days
Vital signs - heart rate	heart rate will be taken.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients admitted to the intensive care unit,
Aged between 18-70 years,
Bedridden, immobile patients,
Patients who have signed the informed consent form themselves or through a close relative.

Exclusion Criteria:

Patients under 18 years of age,
Patients who did not give their consent for the study or whose relatives did not consent, or who wanted to leave while the study was ongoing,
Patients who arrived with bedsores

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

SBU. Van Education and Research Hospital Internal Intensive Care Unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hayrullah ŞAVLI	Contact	+905308981365		hayrullahsavli@gmail.com

Overall Officials

Name	Affiliation	Role
yavuz üren	Yuzuncu Yil University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SBU. Van Education and Research Hospital		Van		65000	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D003668	Pressure Ulcer

Ancestor Terms

ID	Term
D012883	Skin Ulcer
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided