Peripheral Neuropathy Trial, Recruiting
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 Type 1 or Type 2 diabetes
- A doctor has confirmed you have nerve damage in your feet (neuropathy), tested using a simple touch test with a small filament
- You have had a foot ulcer (sore) on the bottom of your foot or toe that fully healed within the last 12 months, putting you in a "high-risk" category
- Any previous foot ulcers are completely healed, confirmed by two medical check-ups at least two weeks apart
- You are able to walk at least 30 steps on your own — using a walker or cane is fine
- You are 18 years of age or older
- You have adequate blood flow to your feet, as measured by specific tests (confirm with trial site if unsure)
- You are willing and able to use special pressure-relieving footwear as directed for the location of your healed ulcer
- You are willing to wear special sensor insoles (Orpyx Sensory Insoles) while walking and at home during waking hours, for at least 5 hours per day
- If you have had a partial foot amputation, it may still be compatible with the insoles, at the doctor's discretion
Who may not be able to join:
- You currently have an open wound or active ulcer on your foot or leg for any reason
- You have been diagnosed with dementia
- You have a psychiatric illness or personal circumstances that might make it difficult to follow the study requirements
- You have a serious heart, lung, or balance condition that stops you from walking at least 30 steps or standing for 5 minutes
- You are currently in, or have recently (within the last 30 days) been in, another clinical study involving a device designed to prevent or offload diabetic foot ulcers
- You are currently enrolled in any other remote foot monitoring program
- You have a bone infection (osteomyelitis) or tissue death (gangrene) in your lower leg or foot
- You have a serious foot joint condition called Charcot neuroarthropathy that has not been treated
- You have a bunion that a doctor believes could cause a new ulcer to form
- You have a severe foot positioning problem called extreme equinus (confirm with trial site)
- Your foot size is larger than a Men's 14 or Women's 12 (US sizing)
- You have an amputation above the ankle
- You have a foot amputation that is not compatible with the insoles, in the doctor's opinion
- You have foot deformities or amputations that would need surgery as the next step in your care, and the study footwear would not adequately help (reviewed by an outside panel)
- Your doctor determines you are not suitable for the trial for another reason
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.
Contact this trial
Principal Investigator: Caitlin Hicks, MD, John's Hopkins University
Phone: +1 (855) 996-7799
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
Where this trial is recruiting
Primary endpoints
Plantar ulcer recurrence
Can't join this trial?
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.