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Can a simple cuff boost achilles rupture healing?

NCT ID NCT06434272

Disease control Sponsor: University of Aarhus Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This trial tests whether adding blood flow restriction exercise (BFR) to usual care improves recovery in people with an acute Achilles tendon rupture treated without surgery. Participants are randomly assigned to receive BFR either early (weeks 1-12) or later (weeks 13-24) after injury. Researchers compare outcomes like heel-rise ability and patient-reported symptoms at 3 and 6 months to see if BFR helps and when starting it is most beneficial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Blood flow restriction exercise (BFR) - a rehabilitation method using a cuff to partially restrict blood flow during low-load exercises
What this could lead to
If effective, BFR could enhance recovery and strength after Achilles tendon rupture, potentially improving long-term function and reducing disability.
What could go wrong
The trial is early and results may not confirm benefit. BFR may cause discomfort or rare complications like blood clots, and optimal timing remains uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 218 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * aged 18 years or older * have started initial treatment within 72 hours of Achilles tendon rupture * understand written and spoken Danish Exclusion Criteria: * bilateral Achilles tendon rupture * previous Achilles tendon rupture in either leg * decreased lower extremity function, caused by conditions other than Achilles tendon rupture * treated with fluoroquinolones within the last six months * treated with corticosteroid injection(s) in the area near the Achilles tendon within the last six months. * diabetes * previous diagnosed thrombosis * Known atherosclerosis in the peripheral arteries of the lower limb * other reasons for exclusion (cognitive deficits, inability to provide informed consent, requiring cast-treatment due to low compliance regarding gradual wedge removal, etc.)

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Achilles tendon rupture

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aarhus University Hospital

    RECRUITING

    Aarhus N, Denmark, 8200, Denmark

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