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New injection aims to heal painful achilles tendons

NCT ID NCT05592990

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times

Summary

This study tested a single injection of tiny particles (NGI226) to see if it safely helps repair damaged Achilles tendons. 45 adults with mid-portion Achilles tendinopathy received either the study drug or a placebo. Researchers measured side effects and changes in tendon stiffness using ultrasound over 12 weeks.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

45 people

The number who actually took part.

Started

Jun 2023

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

30 to 70 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: * Written informed consent must be obtained prior to all study specific screening procedures, as close to the start of the screening period as possible. * Presence of clinically (local Achilles tendon pain on tendon-loading activities, pain on palpation at the level 2-6 cm proximal to the calcaneal insertion) and ultrasound (local tendon thickening with hypoechogenicities and irregular fibre orientation) or MRI diagnosed mid-portion Achilles tendinopathy with symptoms present ≥8 weeks but \<12 months at screening. * The Achilles tendinopathy must have been refractory to at least 6 weeks of conservative treatment (physiotherapy, NSAIDS, RICE), but participants do not need to be in physiotherapy at the time of study entry. Exclusion Criteria: * Medical condition that would affect safety of peritendon injection (e.g., peripheral vascular disease, use of anticoagulant medication) * History of recurrent, acute, symptomatic infections, including outbreaks of oral or genital herpes (\> 2 symptomatic infections or \>2 courses of anti-infective treatments required in the last 6 months; active systemic infection during last 2 weeks; known active infections (e.g. chronic or active Hepatis B or C, HIV) - simple cold excluded * History or evidence of clinically significant cardiac or cardiovascular disease * History of deep vein thrombosis, pulmonary embolism or evidence of primary or secondary hypercoagulable states * History of surgical intervention for the treatment of tendinopathy, history of ankle surgery, ankle arthritis, traumatic, inflammation or deformity of ankle * History of full-thickness tear or complete rupture of the Achilles tendon

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Advanced Research LLC

    Deerfield Beach, Florida, 33064, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Novartis Investigative Site

    Caluire-et-Cuire, 69300, France

  • Novartis Investigative Site

    Berlin, 10117, Germany

  • Novartis Investigative Site

    Hamburg, 20149, Germany

  • Novartis Investigative Site

    Hamburg, 22415, Germany

  • Tucson Orthopedic Institute PC

    Tucson, Arizona, 85712, United States

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