WIREDUP: Wearable Insoles for Recurrent Diabetic Ulcer Prevention

Launched by ORPYX MEDICAL TECHNOLOGIES INC. · Jul 11, 2023

Keywords

ClinConnect Summary

The WIREDUP clinical trial is studying the effectiveness of special wearable insoles called Orpyx® Sensory Insoles in helping people with diabetes prevent foot ulcers. These insoles will be used alongside standard care to see if they can lower the chances of developing ulcers in high-risk individuals. The trial also aims to understand how these insoles might improve participants' quality of life and gather data on their foot health, which could help identify what causes or prevents foot problems.

To participate in this study, you must be at least 18 years old and have either Type 1 or Type 2 diabetes, along with diagnosed nerve damage in your feet. You should have healed any previous foot ulcers and be able to walk independently for at least 30 steps. Participants will need to wear the insoles for a minimum of five hours a day during daily activities. The trial is not yet recruiting, so it’s a good time to learn more about it and see if you or someone you care about may be eligible when it starts.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosed Type 1 or 2 diabetes
• • Clinically diagnosed neuropathy via Neuropathy Monofilament Test
• • 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 (V0 and V1)
• • 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
• • Ability to understand all study requirements and have a life expectancy greater than the study duration
• • Vascular assessment (i.e., ABI, segmental pressure) that demonstrates the participant has adequate lower extremity perfusion
• • 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
• • Compatibility of the device with the participant's footwear
• • Most recent HbA1c level of \< 12.0% (in the last 12 months)
• • Amputations, if present, are compatible with the use of insoles
• Exclusion Criteria:
• • Active ulcer or presence of other open chronic wound (on foot or other body surface), regardless of etiology (e.g., vasculitis, neoplasms, or hematological disorders)
• • History of known non-neuropathic foot ulcer (e.g., arterial, or venous insufficiency ulcer)
• • Presence of severe vascular disease (refer to acceptable ABI parameters in inclusion criteria)
• • Dementia
• • Psychiatric illness or social situations that would limit compliance with the study
• • Serious underlying balance dysfunction, regardless of etiology
• • Significant cardiopulmonary 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
• • Current participation in another clinical investigation of a medical device or a drug; or participation in such a study within 30 days prior to study enrolment
• • Osteomyelitis or gangrene of the lower extremity
• • Uncorrected plantar Charcot neuroarthropathy
• • Bunion which would predispose ulcer formation (clinician discretion)
• • Extreme equinus
• • Hallux valgus
• • Hallux rigidus / limitus
• • HbA1c levels \>= 12%
• • At the start of V1, and prior to randomization, the subject no longer meets the entrance criteria (inclusion and exclusion)
• • Any condition that would affect or limit the ability to properly fit both shoes with the device under study
• • Subject has a history of intercurrent illness or conditions that would compromise the safety of the subject or their ability to participate in the study
• • Amputations on the foot which the clinician deems incompatible with the insoles (i.e., those that require additive insole modifications)