Tracking of Red Blood Cells Using Super Resolution Ultrasound in Persons With Healthy or Overuse Injured Tendons

ConditionTendinopathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorUniversity Hospital Bispebjerg and Frederiksberg

About this trial

The goal of this observational study is to test whether a new ultrasound method, called SUper Resolution ultrasound imaging of Erythrocytes (SURE), can image the small blood vessels found in tendons of persons with a tendon overuse injury (tendinopathy). The main questions it aims to answer are:

* Is the method sensitive enough to detect the smallest blood vessels * What information about the blood flow can be obtained (flow velocity, pressure, shape of the vessels) * Can the flow in an injured tendon be distinguished from that of a healthy one

Participants will receive a non-invasive ultrasound examination of their Achilles (heel) or patellar (knee) tendon, using an advanced high frequency research ultrasound system.

Researchers will compare participants with either an Achilles or patellar tendon overuse injury to participants with healthy tendons, to see if there are distinct differences in the blood vessels that could help diagnose and treat the injuries.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 to 70 years of age.

BMI below 30.

Able to lie still for 1 minute.

Capable of providing signed informed consent.

Disqualifiers

Pregnancy.

Dementia.

Smoking.

Diabetes.

Trial population

Healthy participants: Persons who have no self-reported current or historical injuries to the tendon and surrounding tissue, and display no symptoms of tendinopathy upon examination. Participants with tendinopathy: Persons who have no self-reported current or historical injuries to the tendon and surrounding tissue, aside from a uni- or bi-lateral tendinopathy of the patellar or Achilles tendon based on two clinical criteria: Tendon pain during physical activity and Tendon pain on local palpation.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Super-Resolution Ultrasound Imaging of Erythrocytes (SURE)

    Diagnostic test

    Research ultrasound sequence for tracking erythrocytes and thereby generating a super-resolution image of the vasculature.

Treatment groups

135 Participants
are divided into 3 treatment groups
Group A: Control1 intervention
Group B: Tendinopathy Achilles1 intervention
Group C: Tendinopathy Patellar1 intervention

Trial outcomes

Primary outcomes

1

Vessel density (all)

Mean difference in blood vessel density detected by SURE imaging, between the healthy and tendinopathic group (across both patellar and Achilles).

Time frame
day 0 (the study is cross-sectional)

Secondary outcomes

1

Repeatability (vessel density)

Intraclass correlation of blood vessel density detected by SURE imaging in repeated ultrasound scans of the same tendon across all participants.

Time frame
day 0 (the study is cross-sectional)

Other outcomes

1

Vessel density (PT/AT)

Mean difference in blood vessel density detected by SURE imaging, between the healthy and tendinopathic group (within the patellar or Achilles individually).

Time frame
day 0 (the study is cross-sectional)
2

Other quantifiable measures of microvasculature

To-be-defined quantitative image analysis outcome of the microvasculature (due to the novelty of the method, the exact image analysis pipeline is not yet defined)

Time frame
day 0 (the study is cross-sectional)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Bispebjerg and Frederiksberg

Lead sponsor

Technical University of Denmark

Collaborator