DiabetesWIREDUPNCT05950659
WIREDUP: 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 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Peripheral Neuropathy, Diabetic Foot
- 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
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2026to 1 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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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- 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)
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. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Shannon Hammerlund, MPH, 667-306-9479, shamme11@jh.edu
About this study
Official title: Prevention of Foot Ulcer Recurrence in Individuals Who Are at High-risk for Diabetic Foot Complications Using the Orpyx Sensory Insole System: a Multisite, Randomized, Controlled Trial
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
- Being tested
- Orpyx Sensory Insole System
- Keywords
- Remote Patient Monitoring, Sensor-based Monitoring, Sensory Insoles
- 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 |
|---|---|---|
| Intervention | Experimental | Not described Receives: Device: Orpyx Sensory Insole System |
| Control | No intervention | Not described |
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 (12 months)
Secondary outcomes (4)
Severity of Ulcer Recurrence
Severity of ulcer recurrence will be quantified using the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system.
Measured: From Baseline to End of Study Visit (12 months)
Participant quality of life
Health-related quality of life will be evaluated based on patient responses on the EuroQol- 5 Dimension (EQ-5D), Patient Interpretation of Neuropathy (PIN), and Modified Diabetic Foot-Care Behavior (MDFCB) ratings.
Measured: These will be evaluated at Baseline, 6 months, and 12 months (end of study).
Cost-effectiveness
A prospective cost-effectiveness and cost-utility analysis will be performed comparing the experimental and control arms.
Measured: Baseline to End of Study (12 months)
Participant engagement
For the Intervention arm only, this is measured by the number of successful interactions between the Remote Patient Monitoring (RPM) team and participant.
Measured: Baseline to End of Study (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start22 Apr 2026
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Orpyx Medical Technologies Inc.
- Responsible party
- Sponsor
- Investigators
- Caitlin Hicks, MD, Principal investigator, John's Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950659
- Sponsor's protocol ID
- IRB00527262
- Acronym
- WIREDUP
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2023
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Foot Ulcer Recurrence in Individuals Who Are at High-risk for Diabetic Foot Complications Using the Orpyx Sensory Insole System: a Multisite, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05950659
- Acronym / sponsor ID
- WIREDUP / IRB00527262
- Conditions
- Diabetes, Peripheral Neuropathy, Diabetic Foot, Diabetic Foot Ulcer
- Keywords
- Remote Patient Monitoring, Sensor-based Monitoring, Sensory Insoles
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Orpyx Medical Technologies Inc.
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Orpyx Sensory Insole System |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orpyx Sensory Insole SystemThe 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 | Device | Intervention |
Primary outcome
Plantar ulcer recurrence
Time frame: Baseline to End of Study (12 months)
4 secondary outcomes
Severity of Ulcer Recurrence
Time frame: From Baseline to End of Study Visit (12 months)
Participant quality of life
Time frame: These will be evaluated at Baseline, 6 months, and 12 months (end of study).
Cost-effectiveness
Time frame: Baseline to End of Study (12 months)
Participant engagement
Time frame: Baseline to End of Study (12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caitlin Hicks, MD principal investigator
John's Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Bray (+1 (855) 996-7799, emily.bray@orpyx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plantar ulcer recurrence (time frame: Baseline to End of Study (12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.