NCT05683080

Brief Summary

The aim of this study is to measure the recovery following Achilles tendon rupture. The investigators will use an ultrasound scan to look at the Achilles tendon, they will complete calf strength tests and use questionnaires to measure how individuals are managing in everyday life. The investigators will take these measurements when participants first arrive to the Achilles tendon rupture clinic, after 8 weeks, 10 weeks, 4 months, 6 months and 1 year.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

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

November 10, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

May 24, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

1.9 years

First QC Date

November 10, 2022

Last Update Submit

August 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Ultrasound Tissue Characterisation

    Imaging of the Achilles Tendon

    Week 0, week 8, week 10, 4 months, 6 months and 12 months

Secondary Outcomes (12)

  • Change in Achilles Tendon Rupture Score

    Week 0, week 8, week 10, 4 months, 6 months and 12 months

  • Change in Hospital Anxiety and Depression Scale

    Week 0, week 8, week 10, 4 months, 6 months and 12 months

  • Change in EuroQol- 5 Dimension -5 Level (EQ5D)

    Week 0, week 8, week 10, 4 months, 6 months and 12 months

  • Change in International Physical Activity Questionnaire

    Week 0, week 8, week 10, 4 months, 6 months and 12 months

  • Change in Tampa Scale for Kinesiophobia

    Week 0, week 8, week 10, 4 months, 6 months and 12 months

  • +7 more secondary outcomes

Study Arms (1)

Achilles Tendon Rupture

Individuals who have experienced an Achilles tendon rupture and presented to the Achilles tendon rupture clinic.

Other: Routine Clinical Care

Interventions

Participants completing the research study will receive routine clinical care

Achilles Tendon Rupture

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals who have experienced an Achilles Tendon Rupture and attended the Achilles Tendon Rupture Clinic

You may qualify if:

  • Able to provide informed consent
  • years of age or above

You may not qualify if:

  • Inability to provide informed consent due to cognitive impairment
  • Inability to provide informed consent as unable to understand sufficient English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hosptial of Leicester NHS Trust

Leicester, Leicester, LE1 5WW, United Kingdom

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2022

First Posted

January 12, 2023

Study Start

May 24, 2023

Primary Completion

May 1, 2025

Study Completion

August 1, 2025

Last Updated

September 4, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations