Peripheral Neuropathy Trial, Recruiting NCT06452914 Sponsor: Endocrine Research Solutions Condition: Peripheral Neuropathy
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Peripheral Neuropathy Trial, Recruiting

NCT06452914
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:

  • You have been diagnosed with mild to moderate diabetic neuropathy, with a score between 2 and 7 out of 10 on a standard nerve symptom assessment called the MNSI
  • You are currently experiencing symptoms of diabetic neuropathy
  • You are between 18 and 79 years old
  • You are able and willing to attend follow-up appointments and follow the study guidelines
  • You are willing and able to sign a consent form to participate in the research

Who may not be able to join:

  • You have a history of a nerve or brain condition such as multiple sclerosis or Parkinson's disease
  • You have ongoing pain conditions unrelated to diabetic neuropathy, such as spinal stenosis, lower back pain, or sciatica
  • You have an autoimmune or inflammatory disease other than diabetic neuropathy, such as multiple sclerosis or Lyme disease
  • You have previously had a stroke
  • You have any form of paralysis
  • Your MNSI nerve symptom assessment score is below 2 or above 7 out of 10
  • You have severe peripheral artery disease (poor blood flow to the limbs, confirmed by a specific blood pressure test) (confirm with trial site)
  • You have advanced chronic venous insufficiency, rated above stage 4 (confirm with trial site)
  • You have used any tobacco products within the last 90 days
  • You have an open wound in the area where the treatment would be applied
  • You have started a new medication for diabetic neuropathy symptoms within the last 90 days
  • You are younger than 18 or older than 79 years of age
  • You are unwilling or unable to sign the research consent form
  • The trial investigator believes, for any other reason, that participating may not be appropriate for you or could affect the study results

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 14 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: Gina Myers, INCREDIWEAR HOLDINGS, INC.

Phone: 6788784750

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
Endocrine Research Solutions
Registry
ClinicalTrials.gov
Start date
11 June 2024
Est. completion
1 June 2025

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Improved patient function as determined by pre-treatment and post-treatment Patient Specific Lower Extremity Functional Scale (LEFS), Michigan Neuropathy Screening Instrument (MNSI), and Quality of Life Questionnaire-Diabetic Neuropathy (QOL-DN) compared

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: 14 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