WIREDUP: Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Orpyx Sensory Insole System
DeviceThe 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
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Plantar ulcer recurrence
Time frame
Baseline to End of Study (12 months)Secondary outcomes
1
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.
Time frame
From Baseline to End of Study Visit (12 months)2
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.
Time frame
These will be evaluated at Baseline, 6 months, and 12 months (end of study).3
Cost-effectiveness
A prospective cost-effectiveness and cost-utility analysis will be performed comparing the experimental and control arms.
Time frame
Baseline to End of Study (12 months)4
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.
Time frame
Baseline to End of Study (12 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Orpyx Medical Technologies Inc.
Collaborator
Source ClinicalTrials.gov