Bone Microcirculation After Remote Ischemic Preconditioning

February 22, 2023 updated by: Tobias Kisch, University Hospital Schleswig-Holstein

Effects of Remote Ischemic Preconditioning in Bone Microcirculation

In trauma surgery and hand surgery treatment strategies of none healing bone fractures aim at replacing pseudarthrosis by well vascularized bone and improving microcirculation. Although previous studies indicate that remote ischemic preconditioning (RIPC) can accelerate bone healing in case of non-union, only a few studies focused on the elucidation of its mechanisms of action. Therefore, the aim of this study is to evaluate the microcirculatory effects of remote ischemic preconditioning (RIPC) on scaphoid bones and metacarpal bones and metatarsal bones in a human in-vivo setting for the first time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • University of Schleswig-Holstein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Group A (n=20): Consent-capable male and female patients ≥18 years of age who have an intact scaphoid bone.
  • Group B (n=20): Consent-capable male and female patients ≥18 years of age who have an intact metacarpal bone.
  • Group C (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured scaphoid bone.
  • Group D (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured metacarpal bone.

Exclusion Criteria:

  • below 18 years of age
  • scar tissue above measuring focus
  • osteoporosis or comparable bone disease
  • medication that influences bones

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intact scaphoid bone

Group A (n=20): Consent-capable male and female patients ≥18 years of age who have an intact scaphoid bone.

Intervention: Remote Ischemic Preconditioning (by Blood Pressure Cuff)
Procedure: Remote Ischemic Preconditioning (by Blood Pressure Cuff)
Remote Ischemik Preconditioning is performed using a Blood Pressure Cuff with a pressure slightly above patients' blood pressure on the upper arm.
Experimental: Intact metacarpal bone

Group B (n=20): Consent-capable male and female patients ≥18 years of age who have an intact metacarpal bone.

Intervention: Remote Ischemic Preconditioning (by Blood Pressure Cuff)
Procedure: Remote Ischemic Preconditioning (by Blood Pressure Cuff)
Remote Ischemik Preconditioning is performed using a Blood Pressure Cuff with a pressure slightly above patients' blood pressure on the upper arm.
Experimental: Fractured scaphoid bone

Group C (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured scaphoid bone.

Intervention: Remote Ischemic Preconditioning (by Blood Pressure Cuff)
Procedure: Remote Ischemic Preconditioning (by Blood Pressure Cuff)
Remote Ischemik Preconditioning is performed using a Blood Pressure Cuff with a pressure slightly above patients' blood pressure on the upper arm.
Experimental: Fractured metacarpal bone

Group D (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured metacarpal bone.

Intervention: Remote Ischemic Preconditioning (by Blood Pressure Cuff)
Procedure: Remote Ischemic Preconditioning (by Blood Pressure Cuff)
Remote Ischemik Preconditioning is performed using a Blood Pressure Cuff with a pressure slightly above patients' blood pressure on the upper arm.
Experimental: Intact metatarsal bone

Group B (n=20): Consent-capable male and female patients ≥18 years of age who have an intact metatarsal bone.

Intervention: Remote Ischemic Preconditioning (by Blood Pressure Cuff)
Procedure: Remote Ischemic Preconditioning (by Blood Pressure Cuff)
Remote Ischemik Preconditioning is performed using a Blood Pressure Cuff with a pressure slightly above patients' blood pressure on the upper arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in microcirculation (composite outcome measure)
Time Frame: Baseline and 1 minute post-dose
  • Bone blood flow [arbitrary units AU]
  • Bone blood velocity [AU]
  • Tissue oxygen saturation [%]
  • Relative postcapillary venous filling pressure [AU] (Composite outcome measure)
Baseline and 1 minute post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Schleswig-Holstein

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

September 16, 2015

First Submitted That Met QC Criteria

September 16, 2015

First Posted (Estimate)

September 18, 2015

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-266-5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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