Phase 2 Peripheral Neuropathy Trial, Recruiting NCT04460573 Sponsor: University of Southern California Condition: Peripheral Neuropathy
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Phase 2 Peripheral Neuropathy Trial, Recruiting

NCT04460573
Recruiting Phase 2

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 male or female and aged 18 or older
  • People who have a diabetic foot ulcer (an open wound on the foot related to diabetes) that is not infected and does not have reduced blood flow, and that needs pressure to be taken off it to heal
  • People who are able to walk around at home, with or without help from another person or a device
  • People who are willing and able to sign a written consent form agreeing to take part

Who may not be able to join:

  • People whose wound has been present for longer than one year
  • People whose HbA1c (a measure of average blood sugar levels over time) is above 12%
  • People whose blood flow to the affected leg is below a certain level, whose blood flow cannot be measured using sound wave testing, or who are being considered for a procedure to improve blood flow to that limb during the study period
  • People who have an active Charcot neuropathy (a serious bone and joint condition in the foot) or a major foot shape problem that would prevent them from wearing the study's special smart boot
  • People who have had an amputation above the back of the foot on the affected leg
  • People who have a significant medical or mental health condition (confirm with trial site)
  • People who have abnormal lab test results that could interfere with taking part in the study (confirm with trial site)
  • People who are currently doing a structured exercise training program
  • People who have had changes made to their mental health or sleep medications within the last six weeks
  • People whose ulcer extends into the bone
  • People whose foot ulcer is not caused by diabetes
  • People who are unable or unwilling to attend required clinic visits or follow the study's instructions

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 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: David G Armstrong, DPN, MD, PhD, Professor of Surgery, Keck School of Medicine of USC

Phone: 3235162332

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
Phase 2
Registry
ClinicalTrials.gov
Start date
19 October 2021
Est. completion
31 March 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Wound healing at 12 weeks or sooner; Time to wound healing

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: 27 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