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New nail aims to stop ankle infections in their tracks

NCT ID NCT06428448

Disease control Sponsor: OsteoRemedies, LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new medical device called the REMEDY SPECTRUM GV IM Spacer Nail for treating ankle-related infections. About 60 adults with ankle infections will receive the nail and be followed for 6 months. The goal is to see if the nail safely clears the infection and helps the wound heal.

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

About 60 people

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

Started

Feb 2026

Expected to finish

Dec 2027

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

21 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Be ≥ 21 years of age 2. Have an ankle-related infection 3. Is skeletally mature, as evidenced by closed epiphyses. 4. Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study 5. Be willing and able to comply with all study procedures including all pre-operative, post-operative requirements 6. If female and of child-bearing potential, must have a negative pregnancy test prior to the surgical procedure and no intention of becoming pregnant until study completion. Exclusion Criteria: 1. Infections that do not involve the ankle 2. Have a known immunodeficiency; including subjects who are receiving or have received immunosuppressants, immunostimulating agents or radiation therapy within 6 months prior to surgery 3. Affected limb is dysvascular 4. Where adequate soft-tissue coverage cannot be achieved 5. Have any mental or psychological disorder that would impair their ability to complete the study questionnaires 6. Are currently pregnant or breastfeeding, or planning to become pregnant or breastfeed any time during the course of the study 7. Are currently a prisoner 8. Have any medical condition or other circumstances, in the judgment of the Investigator, that might interfere with the ability to return for follow-up visits, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the subject unable to perform appropriate post-operative activities. 9. History of vancomycin or gentamicin allergy 10. Are implanted with other antibiotic eluting products.

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Conditions

The condition(s) this trial relates to.

periprosthetic joint infection

As listed by the trial registrant

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

Periprosthetic joint infection

How to take part

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

  1. The places running it

    3 sites. 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

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • OrthoCarolina Research Institute

    RECRUITING

    Charlotte, North Carolina, 28207, United States

  • University of Michigan Health - Sparrow Clinical Research Institute

    RECRUITING

    Lansing, Michigan, 48190, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.