REMEDY SPECTRUM Nail for Ankle Infections

Study to Evaluate the REMEDY SPECTRUM GV IM Spacer Nail in the Treatment of Ankle-Related Infections

Recruiting Phase 2 Interventional Study
Periprosthetic Joint Infection
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
21 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
OsteoRemedies, LLC · Industry
Who this trial is looking for

This trial is looking for adults with ankle-related infections to test a new treatment. Participants will receive the REMEDY SPECTRUM IM Spacer Nail and will need to complete some follow-up visits.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 21 years old
  • I have an ankle-related infection
  • I can give my written consent to participate
  • I am willing to follow the study procedures
  • If I am a woman who can get pregnant, I have a negative pregnancy test

You may not be able to join if

  • I have an infection that does not involve my ankle
  • I have a known immune deficiency
  • My affected limb has poor blood flow
  • I cannot have adequate soft-tissue coverage
  • I have a mental health disorder that affects my ability to participate
  • I am pregnant or breastfeeding
  • I am a prisoner
  • I have had an allergy to vancomycin or gentamicin

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial
This study is being conducted to evaluate the safety and effectiveness of the REMEDY SPECTRUM IM Spacer Nail in the treatment of ankle-related infections. The study is expected to take approximately 18 months from first subject enrolled to the last follow-up visit. It will have a 12-month enrollment period and a 6-month follow-up. This study is a Prospective, multicenter, single-arm clinical trial…
Trial Locations
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Eligibility Criteria
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 c…
Contacts

Crystal Djaba

470-736-7850

cdjaba@mcra.com

CONTACT

Jacob Schafer

jschafer@mcra.com

CONTACT