Wearable Insoles for Recurrent Diabetic Ulcer Prevention (WIREDUP)

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, as compared to standard of care alone, 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes; Diabetic Foot Ulcer; Peripheral Neuropathy
• Intervention / Treatment: Device: Orpyx Sensory Insole System

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University Hospital

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
• 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)

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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Orpyx Sensory Insole System 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plantar ulcer recurrence	Baseline to End of Study (3 months)

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Orpyx Medical Technologies Inc.
• Investigators: Principal Investigator: Caitlyn Hicks, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Remote Patient 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: IRB00382559

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.: No