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Could a blood flow cuff speed up achilles recovery?

NCT ID NCT07498166

Symptom relief Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether using a special cuff that limits blood flow during exercise can help people recover muscle strength and function after Achilles tendon repair surgery. 75 adults who had surgery for a torn Achilles tendon will be randomly assigned to either this blood flow restriction training plus standard physical therapy, a sham version, or standard therapy alone. Researchers will measure strength, muscle size, and patient-reported outcomes over 12 months.

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 resistance training using a personalized tourniquet system
What this could lead to
If it works, this could offer a safer way to rebuild muscle strength after Achilles tendon surgery without putting too much stress on the healing tendon.
What could go wrong
This is a small, early-stage trial with only 75 participants, so results may not apply to everyone. The device is experimental and may not improve recovery more than standard rehab.

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 75 people

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

Started

Feb 2026

Expected to finish

Feb 2027

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 to 75 years

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 * Adults aged 18 to 75 years * Acute unilateral midportion Achilles tendon rupture * Primary surgical repair performed within 2 weeks of injury * Willingness and ability to comply with the postoperative rehabilitation protocol and follow-up schedule Exclusion Criteria: * Cognitive impairment or inability to follow study instructions * Planned postoperative follow-up at another institution * Use of fluoroquinolone antibiotics or systemic corticosteroids within the past 6 months * Previous Achilles tendon rupture in either limb * Simultaneous bilateral Achilles tendon rupture * History of venous thromboembolism (deep venous thrombosis or pulmonary embolism) * Diabetes mellitus * Reduced lower extremity function due to conditions other than Achilles tendon rupture * Uncontrolled hypertension * Peripheral vascular disease or ankle-brachial index less than 1.0 * Chronic kidney disease or heart failure with lower extremity edema * Lower extremity dialysis access * Lower extremity thrombophlebitis * Active cancer or ongoing chemotherapy treatment * Prior lymphadenectomy * Tumor or malignancy affecting the lower extremities * Hemophilia or other major bleeding disorders * Factor V Leiden mutation or known thrombophilia * Sickle cell anemia * Pregnancy * Surgery within the previous month

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Conditions

The condition(s) this trial relates to.

Tendon Injuries

As listed by the trial registrant

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

Achilles tendon repairs/reconstructions Achilles tendon rupture Blood flow restriction therapy Dynamic blood flow restriction

Contacts and locations

Locations

  • Massachusetts General Hospital, Department of Orthopaedics

    Boston, Massachusetts, 02114, United States

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