WIREDUP: Wearable Insoles for Recurrent Diabetic Ulcer Prevention (WIREDUP)

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes; Diabetic Foot; Diabetic Foot Ulcer; Peripheral Neuropathy
• Intervention / Treatment: Device: Orpyx Sensory Insole System

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily Bray; Phone Number: +1 (855) 996-7799; Email: emily.bray@orpyx.com

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins Hospital
      • Contact: Shannon Hammerlund, MPH; Phone Number: 667-306-9479; Email: shamme11@jh.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Device: 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
No Intervention: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plantar ulcer recurrence	Baseline to End of Study (12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline to End of Study (12 months)

Collaborators and Investigators

• Sponsor: Orpyx Medical Technologies Inc.
• Collaborators: Johns Hopkins University; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Caitlin Hicks, MD, John's Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Remote Patient Monitoring; Sensor-based Monitoring; Sensory Insoles
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neuromuscular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Ulcer; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Diabetes Mellitus; Peripheral Nervous System Diseases; Diabetic Foot
• Other Study ID Numbers: WIREDUP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes