Recruiting

Orpyx

Sponsor:

Johns Hopkins University

Code:

NCT05950659

Conditions

Diabetes

Peripheral Neuropathy

Diabetic Foot

Diabetic Foot Ulcer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Orpyx Sensory Insole System

Study Details

Brief summary:

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.

Conditions

Diabetes

Peripheral Neuropathy

Diabetic Foot

Diabetic Foot Ulcer

Study ID

NCT05950659

Start date

Apr 22, 2026

Status verified date

Jul, 2026

Completion date

May 1, 2029

Anticipated

Primary completion date

May 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention

no intervention: Control

Interventions

Orpyx Sensory Insole System

The Orpyx Sensory Insoles System uses Orpyx Sensory Technology: a powered limb overload warning technology intended for monitoring physiologic parameters, such as plantar pressure, temperature, motion, and adherence, and providing real-time cues for pressure offloading

Primary outcome measure

  • Plantar ulcer recurrence [ Time Frame: Baseline to End of Study (12 months) ]

Central Contacts and Locations

Central contacts

Emily Bray

+1 (855) 996-7799emily.bray@orpyx.com

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Shannon Hammerlund, MPH

667-306-9479shamme11@jh.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • Remote Patient Monitoring
  • Sensor-based Monitoring
  • Sensory Insoles

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-07-14.