NCT07394829

Brief Summary

After surgery, elastic compression is commonly used on the legs to support blood circulation and reduce the risk of complications such as swelling and venous thromboembolism. In clinical practice, compression is usually applied at fixed pressure levels, although individual patients may respond differently depending on their circulation and tissue tolerance. The purpose of this pilot study is to evaluate how different compression pressure levels affect peripheral circulation in adult patients during the early postoperative period. Participants will receive three different levels of leg compression applied sequentially under controlled conditions. Peripheral circulation will be assessed using non-invasive methods, including photoplethysmography and peripheral perfusion index measurements. The findings of this study are expected to provide preliminary evidence on individual circulatory responses to different compression pressures and to support the development of more personalized postoperative compression strategies in future clinical practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2026

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

January 31, 2026

Last Update Submit

April 5, 2026

Conditions

Postoperative Circulatory ChangesPeripheral Vascular DiseasesVenous Insufficiency of Leg

Keywords

Elastic compressionCompression pressurePostoperative carePeripheral perfusion indexLower extremity circulationPilot study

Outcome Measures

Primary Outcomes (2)

  • Peripheral Perfusion Index (PPI)

    Peripheral Perfusion Index (PPI) will be measured as a dimensionless numerical value using a non-invasive photoplethysmography-based monitoring device. PPI represents the ratio of pulsatile to non-pulsatile blood flow and serves as an objective indicator of peripheral microcirculatory perfusion. Measurements will be obtained at four predefined time points: baseline before compression (T0), after application of 30 mmHg compression (T1), after application of 45 mmHg compression (T2), and after application of 60 mmHg compression (T3). All measurements will be performed in the supine position following a standardized rest period of at least 10 minutes.

    Baseline (T0) and during sequential compression applications (T1-T3) within the first 48 hours after surgery

  • Venous Filling Time Measured by Photoplethysmography (seconds)

    Venous filling time will be measured in seconds (s) using non-invasive photoplethysmography to assess venous hemodynamic response of the lower extremity. Venous filling time reflects the rate of venous refilling following compression release. Measurements will be recorded at baseline (T0) and after each compression pressure level: 30 mmHg (T1), 45 mmHg (T2), and 60 mmHg (T3), using standardized sensor placement at the calf region in the supine position. .

    Baseline (T0) and during sequential compression applications (T1-T3) within the first 48 hours after surgery

Secondary Outcomes (3)

  • Lower Extremity Edema (Circumference Measurement, cm)

    Baseline (T0) and during sequential compression applications (T1-T3) within the first 48 hours after surgery

  • Skin Surface Temperature (°C)

    Baseline (T0) and during sequential compression applications (T1-T3) within the first 48 hours after surgery

  • Patient Comfort Assessed by Visual Analog Scale (VAS, 0-10)

    Baseline (T0) and during sequential compression applications (T1-T3) within the first 48 hours after surgery

Study Arms (1)

Sequential Compression Pressure Intervention

EXPERIMENTAL

All participants will receive sequential lower extremity compression at three predefined pressure levels (30 mmHg, 45 mmHg, and 60 mmHg) applied to the calf region during the early postoperative period, with repeated measurements at each pressure level within the same participant.

Device: Pressure-Controlled Compression Device

Interventions

Pressure-Controlled Compression DeviceDEVICE

A pressure-controlled compression device will be applied to the calf region to deliver sequential compression at three predefined pressure levels: low (30 mmHg), moderate (45 mmHg), and high (60 mmHg). Each pressure level will be applied for a fixed duration with rest periods between applications to allow peripheral circulation to return to baseline. Compression will be performed in the supine position during the early postoperative period.

Sequential Compression Pressure Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 to 65 years
  • Undergoing elective surgery
  • In the early postoperative period at the time of assessment
  • Hemodynamically stable
  • Intact skin on the lower extremities at the planned compression sites
  • Able to understand the study procedures
  • Willing and able to provide written informed consent

You may not qualify if:

  • Peripheral arterial disease or clinically significant arterial insufficiency
  • Current or previous diagnosis of deep vein thrombosis or venous thromboembolism
  • Known peripheral neuropathy or sensory impairment affecting the lower extremities
  • Open wounds, active infection, or dermatological conditions on the lower extremities
  • Severe edema requiring therapeutic intervention beyond standard postoperative care
  • Inability to tolerate compression therapy due to pain or discomfort
  • Pregnancy
  • Participation in another interventional clinical study during the same hospitalization period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ağrı Training and Research Hospital

Ağrı, Merkez, Turkey (Türkiye)

Location

Related Publications (5)

  • van Genderen ME,Paauwe J,de Jonge J,van der Valk RJ,Lima A,Bakker J,van Bommel J

    BACKGROUND

  • Ren W,Duan Y,Jan YK,Li J,Liu W,Pu F,Fan Y

    BACKGROUND

  • Agerskov M,Thusholdt ANW,Højlund J,Meyhoff CS,Sørensen H,Wiberg S,Secher NH,Bang Foss N

    BACKGROUND

  • Sun X, He H, Xu M, Long Y. Peripheral perfusion index of pulse oximetry in adult patients: a narrative review. Eur J Med Res. 2024 Sep 11;29(1):457. doi: 10.1186/s40001-024-02048-3.

    PMID: 39261939BACKGROUND

  • Sun X,He H,Xu M,Long Y

    BACKGROUND

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: All participants will receive sequential compression pressure levels applied in a single group design, with repeated measurements at each pressure level within the same participant.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 31, 2026

First Posted

February 6, 2026

Study Start

February 15, 2026

Primary Completion

April 1, 2026

Study Completion

April 5, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to the pilot nature of the study, the small sample size, and the single-center design. The collected data include detailed physiological measurements that could potentially increase the risk of participant re-identification. Aggregate and de-identified results will be reported in scientific publications in accordance with ethical approval and data protection regulations.

Locations

TU(1)