Wearable Insoles to Help Prevent Diabetic Foot Ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates whether adding Orpyx Sensory Insole System to usual care lowers the incidence of plantar ulcers in adults with diabetes and neuropathy who are at high risk. Participants will be followed to collect plantar pressure, temperature, step counts, movement, and adherence data to identify patterns linked to ulcer development. Secondary outcomes include quality of life, participant engagement, and economic measures such as cost-effectiveness. The study uses a real-world data approach to understand how sensor-based monitoring might improve prevention of diabetic foot complications. The trial is led by Johns Hopkins University with collaboration from NIDDK and Orpyx.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosed Type 1 or 2 diabetes
* Clinically diagnosed neuropathy via Neuropathy Monofilament Test (Appendix A)
* Qualification as a "high-risk participant," meaning a recent history (\<12 months) of a healed diabetic neuropathic ulceration on the weight-bearing surface of one or both feet (this includes the plantar distal toe surface)
* Complete healing of any previous foot ulcers, as defined by complete re-epithelialization of that ulcer which is confirmed by two medical exams that occur at least two weeks apart (screening visit and baseline study visit)
* Ability to walk independently (without use of wheelchair) for 30 steps. Use of a walker or cane is acceptable as long as the participant can walk for at least 30 steps.
* Aged \>18 years
* ABI \> 0.6 or TBI \> 0.4 or palpable pulses or evidence of healing in the last 2 months. If ABI \< 0.4, the patient's vascular lab studies (ABI, TBI, pulse volume recordings) will be reviewed by the study PI and a co-I vascular surgeon at USC.
* Subject is willing and able to maintain the required offloading (as applicable for the location of the healed ulcer)
* Subject is willing and able to wear the Orpyx Sensory Insoles during ambulatory activity and at home during waking hours, and for a minimum of 5 hours per day
* Amputations, if present, are compatible with the use of insoles at physician discretion (e.g. Transmetatarsal Amputation (TMA) are acceptable)

Exclusion Criteria:

* Active ulcer or presence of other open chronic wound (on foot or leg), regardless of etiology (e.g., vasculitis, neoplasms, or hematological disorders)
* Dementia
* Psychiatric illness or social situations that would limit compliance with the study
* Significant cardiopulmonary, severe imbalance, or other systemic disease limiting the participant's ability to walk at least 30 steps or to stand for an amount of time equal to or greater than five (5) minutes (self-reported)
* Current participation in another clinical investigation of a similar medical device designed to offload or prevent diabetic foot ulcer formation; or participation in such a study within 30 days prior to study enrollment, per physician discretion
* Current enrollment in any other remote patient pedal monitoring (RPPM) program
* Osteomyelitis or gangrene of the lower extremity
* Uncorrected plantar Charcot neuroarthropathy
* Bunion which would predispose ulcer formation (clinician discretion)
* Extreme equinus
* At the start of V1, and prior to randomization, the subject no longer meets the entrance criteria (inclusion and exclusion)
* Above ankle amputation
* Amputations not compatible with the insole, per physician discretion
* Foot deformities or amputations that require surgical intervention as the next step in standard of care, and that the study footwear and device would not adequately address (to be adjudicated by an outside review panel).
* Brannock-measured foot size \> Men's 14 (Women's 12)
* Physician discretion

Where it's running

• Johns Hopkins Hospital
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Caitlin Hicks, MD — John's Hopkins University
• Study coordinator: Emily Bray
• Email: emily.bray@orpyx.com
• Phone: +1 (855) 996-7799

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.