DiabetesWIREDUPNCT07674420
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
A study testing Orpyx Sensory Insole System in people with Diabetes and Peripheral Neuropathy, run by Johns Hopkins University at 1 site in United States.
Trial summary
The primary objective of the study is to demonstrate the clinical advantages of using the Orpyx SI Sensory Insole (SI) system as an adjunct to standard of care in reducing plantar ulceration in high-risk individuals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Peripheral Neuropathy, Diabetic Foot Ulcer
- What is being tested?
- Orpyx Sensory Insole System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2023to Nov 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Ankle-Brachial Index (ABI) > 0.6 or Toe-Brachial Index (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 Principal Investigator and a Co-Investigator vascular surgeon
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University Hospital
Baltimore, Maryland, 21287
About this study
The primary objective of the study is to demonstrate the clinical advantages of using the Orpyx SI Sensory Insole (SI) system as an adjunct to standard of care in reducing plantar ulceration in high-risk individuals. The investigators aim to understand participant quality of life, the economic impact and cost-effectiveness of the Orpyx SI insole system, and to evaluate participant engagement and compliance.
- Conditions
- Diabetes, Peripheral Neuropathy, Diabetic Foot Ulcer
- Being tested
- Orpyx Sensory Insole System
- Keywords
- Sensory Insoles, Remote Patient Monitoring
- Medical subject headings
- Diabetes Mellitus, Peripheral Nervous System Diseases, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orpyx Sensory Insole SystemDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Orpyx Sensory Insole System Intervention | Experimental | Not described Receives: Device: Orpyx Sensory Insole System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plantar ulcer recurrence
Measured: Baseline to End of Study (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start17 Oct 2023
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Orpyx Medical Technologies Inc.
- Responsible party
- Sponsor
- Investigators
- Caitlyn Hicks, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674420
- Sponsor's protocol ID
- IRB00382559
- Acronym
- WIREDUP
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No