WIREDUP: Wearable Insoles for Recurrent Diabetic Ulcer Prevention

This study is testing the Orpyx® Sensory Insoles System to see if it can help prevent diabetic foot ulcers (sores) from coming back. These special insoles monitor things like pressure and temperature in your feet and give you real-time feedback to help you relieve pressure. The study wants to see if using these insoles along with standard care is better than standard care alone at preventing new ulcers over 12 months. You might be able to join if you have type 1 or 2 diabetes, nerve damage in your feet (neuropathy), and have had a healed diabetic foot ulcer in the last year. The study is also looking at how the insoles affect your quality of life and the economic impact.

Study design: This study is an interventional study planning to enroll 400 participants. It compares the Orpyx Sensory Insole System plus standard care to standard care alone.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed from baseline to the end of the study, which is 12 months, to measure plantar ulcer recurrence.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

WIREDUP: Wearable Insoles for Recurrent Diabetic Ulcer Prevention

Recruiting

NAAges 18+InterventionalPrevention

Johns Hopkins University

~400 participants

Updated 2026-07-14 on ClinicalTrials.gov

What's tested:Orpyx Sensory Insole System

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Plantar ulcer recurrence

Measured over Baseline to End of Study (12 months)

Conditions

Diabetes

Peripheral Neuropathy

Diabetic Foot

Diabetic Foot Ulcer

Where it's being run

1 sites across 1 states

Maryland1

Study leadership

Caitlin Hicks, MD · PRINCIPAL_INVESTIGATOR · John's Hopkins University

Who to contact

Emily Bray

[email protected]

+1 (855) 996-7799

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)

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

Exclusion

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

What this trial measures

Plantar ulcer recurrenceBaseline to End of Study (12 months)

Trialytics