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Bone Microcirculation After Remote Ischemic Preconditioning

Effects of Remote Ischemic Preconditioning in Bone Microcirculation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02554500
Enrollment
80
Registered
2015-09-18
Start date
2015-09-30
Completion date
2023-02-28
Last updated
2023-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fractured Metacarpal Bone, Fractured Scaphoid Bone, Intact Metacarpal Bone, Intact Scaphoid Bone

Brief summary

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.

Interventions

PROCEDURERemote 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.

Sponsors

University Hospital Schleswig-Holstein
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in microcirculation (composite outcome measure)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)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026