NCT06142747

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Feb 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress58%
Feb 2024Jan 2028

First Submitted

Initial submission to the registry

November 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

February 8, 2024

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

3.9 years

First QC Date

November 15, 2023

Last Update Submit

January 20, 2026

Conditions

Keywords

Tendon Overuse InjuryAchilles TendonPatellar TendonUltrasonography

Outcome Measures

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).

    day 0 (the study is cross-sectional)

Secondary Outcomes (1)

  • Repeatability (vessel density)

    day 0 (the study is cross-sectional)

Other Outcomes (2)

  • Vessel density (PT/AT)

    day 0 (the study is cross-sectional)

  • Other quantifiable measures of microvasculature

    day 0 (the study is cross-sectional)

Study Arms (3)

Control

Healthy Controls. Super-Resolution Ultrasound Imaging of Erythrocytes (SURE) of both Achilles and Patellar Tendons.

Diagnostic Test: Super-Resolution Ultrasound Imaging of Erythrocytes (SURE)

Tendinopathy Achilles

Patients with Achilles Tendinopathy. Super-Resolution Ultrasound Imaging of Erythrocytes (SURE) of Achilles Tendons.

Diagnostic Test: Super-Resolution Ultrasound Imaging of Erythrocytes (SURE)

Tendinopathy Patellar

Patients with Patellar Tendinopathy. Super-Resolution Ultrasound Imaging of Erythrocytes (SURE) of Patellar Tendons.

Diagnostic Test: Super-Resolution Ultrasound Imaging of Erythrocytes (SURE)

Interventions

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

Also known as: Ultrasonography
ControlTendinopathy AchillesTendinopathy Patellar

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • to 70 years of age.
  • BMI below 30.
  • Able to lie still for 1 minute.
  • Capable of providing signed informed consent.

You may not qualify if:

  • Pregnancy.
  • Dementia.
  • Smoking.
  • Diabetes.
  • Arthritis.
  • Current or historical injuries to the tendon or surrounding tissue aside from tendinopathy.
  • Medical or surgical treatments for their tendinopathy that may influence blood flow.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports Medicine

Copenhagen, 2400, Denmark

RECRUITING

MeSH Terms

Conditions

Tendinopathy

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Michael Kjaer, PhD

    University Hospital Bispebjerg and Frederiksberg

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 21, 2023

Study Start

February 8, 2024

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

January 22, 2026

Record last verified: 2026-01

Locations