New injection aims to heal painful achilles tendons
NCT ID NCT05592990
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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45 people
The number who actually took part.
- Started
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Jun 2023
- Finished
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Feb 2026
- Lead sponsor
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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
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30 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Advanced Research LLC
Deerfield Beach, Florida, 33064, United States
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Houston Methodist Hospital
Houston, Texas, 77030, United States
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Novartis Investigative Site
Caluire-et-Cuire, 69300, France
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Novartis Investigative Site
Berlin, 10117, Germany
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Novartis Investigative Site
Hamburg, 20149, Germany
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Novartis Investigative Site
Hamburg, 22415, Germany
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Tucson Orthopedic Institute PC
Tucson, Arizona, 85712, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Tendon pain showdown: which injection works better?
- Keyhole surgery may beat open cuts for achilles repair
- Pilates put to the test for achilles pain relief
- Exercise study for sore achilles tendons pulled before it began
- New tool may predict who will suffer after achilles surgery