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Can collagen shots around the heel tendon speed recovery?

NCT ID NCT05464498

Symptom relief Sponsor: Guna S.p.a 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Achilles tendinopathy is a painful condition of the tendon at the back of the ankle. Researchers are testing whether injecting a collagen-based medical device around the tendon, combined with a physiotherapy program of eccentric strengthening exercises, improves pain and function more than physiotherapy alone. The trial enrolls 72 adults with recent tendon pain and measures changes using a standard Achilles questionnaire.

What this could mean

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

Active substance
a collagen-based medical device injected around the tendon
What this could lead to
If it works, collagen injections plus physiotherapy could become a way to ease Achilles tendon pain and help people move better.
What could go wrong
The trial is small and early, so results may not hold up in larger studies. Injections can cause soreness or reactions, and physiotherapy alone may work just as well.

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 72 people

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

Started

Jun 2022

Expected to finish

Nov 2026

An estimate. End dates often move.

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

18 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: * Male and female subjects aged 18 to 70 years; * Subjects with tendon pain for not more than 24 weeks; * Subjects with clinically diagnosed and ultrasonographically confirmed insertional/noninsertional/mystic tendinopathy; * Subjects with a VISA A score between 50 and 75; * VAS ≥ 5; * Subjects able to understand and answer the SF12 questionnaire; * Subjects able to understand and sign the informed consent. Exclusion Criteria: * subjects who have had surgery in the investigated area or lower extremity; * subjects who have previously undergone physiotherapy. * subjects with autoimmune diseases; * subjects with peripheral neuropathy; * subjects with calcific tendinopathy * subjects with pain of direct traumatic origin; * subjects with local/systemic infections; * subjects with neoplastic diseases; * subjects with gout; * subjects on corticosteroid treatment at the time of enrollment; * subjects who have used corticosteroids or fluoroquinolones in the three months prior to enrollment; * subjects who have used NSAIDs in the week prior to enrollment; * subjects who are pregnant and lactating; * subjects with contraindications to acetaminophen use; * allergy to porcine collagen.

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Conditions

The condition(s) this trial relates to.

disease of the tendon Osteogenesis Imperfecta, Type IV tenosynovitis

As listed by the trial registrant

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

Achilles tendinopathy Insertional achilles tendinopathy Peritendinitis Tendinopathy

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

  • U.O.C. Medicina Fisica e Riabilitativa dell'AOU "Policlinico Umberto I°"

    RECRUITING

    Roma, RO, 00185, Italy

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