WIREDUP: Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
The primary aim of this study is to demonstrate the impact of the Orpyx® Sensory Insoles (Orpyx Medical Technologies Inc., Calgary AB, Canada) ("Orpyx" or "the Company") as an adjunct to the standard of care (SOC), as compared to SOC alone, on reducing plantar ulceration incidence in individuals who are at risk for developing diabetic foot complications. The secondary aims of this study are to evaluate participant quality of life, participant engagement, and economic impact, including cost-effectiveness and cost-utility. The study will also use the unique data set collected (plantar pressure, temperature, step count, movement and adherence feedback) to identify foot-loading histories that either lead to or prevent the development of ulceration in the diabetic foot.
Sponsor: Johns Hopkins University
You may qualify if…
- ✓ 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)
You may not qualify if…
- ✕ 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
Where it's recruiting
Baltimore
Source: ClinicalTrials.gov · NCT05950659 · last updated 2026-07-14