Peripheral Neuropathy Trial, Recruiting NCT06939686 Sponsor: Reprise Biomedical, Inc. Condition: Peripheral Neuropathy
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Peripheral Neuropathy Trial, Recruiting

NCT06939686
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are at least 18 years old and able to give informed consent
  • People who have a foot wound or ulcer classified as Wagner Grade 1 (a shallow wound that may be full or partial thickness); if the wound is near the ankle bone, no more than half of it can be above the midpoint of that bone (confirm with trial site)
  • People whose wound, after cleaning, measures between 1 cm² and 20 cm² in size
  • People whose wound has been present for at least 4 weeks before the screening visit
  • People who have documented evidence of adequate blood flow to the affected area, based on one of several accepted tests (confirm with trial site for which tests apply)
  • People whose other wounds, if any, are located at least 2 cm away from the main wound being studied
  • People who have had any previous wound infections that have been fully treated according to established medical guidelines
  • People who are able to use offloading or compression devices as required, have a stable home environment, and can attend follow-up appointments
  • People who agree to have digital photos taken of their wound
  • People joining the Miro3D treatment group must have a wound with a clean base, free of dead tissue or debris, at the time of treatment

Who may not be able to join:

  • People whose wound has already shrunk by 30% or more after two weeks of standard care between the screening and baseline visits
  • People with poorly controlled diabetes, indicated by an HbA1c level of 12% or higher
  • People with active, untreated, or uncontrolled bone infection (osteomyelitis)
  • People with cancer or blood vessel inflammation present at the wound site
  • People currently receiving chemotherapy
  • People currently on dialysis
  • People who have used experimental drugs or treatments within the 30 days before screening
  • People with health conditions that would make it difficult to safely participate in or complete the study (confirm with trial site)
  • People with a known allergy or sensitivity to pig-derived materials
  • People with third-degree burns
  • People showing signs of worsening poor blood flow or gangrene at the time of screening
  • People who have previously had radiation treatment at the wound site
  • People whose wound exposes internal surgical hardware, implants, or fixation devices
  • People who are transitioning to palliative or comfort-focused care

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Robert J. Snyder, DPM, Barry University

Phone: 954-721-4806

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Reprise Biomedical, Inc.
Registry
ClinicalTrials.gov
Start date
1 November 2024
Est. completion
31 July 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Percent Area Reduction (PAR) and Granulation Tissue Formation at 4 Weeks

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov