Orpyx Insoles for Diabetic Foot

(WIREDUP Trial)

Overseen By Emily Bray

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Orpyx Medical Technologies Inc.

Disqualifiers: Active ulcer, Dementia, Psychiatric illness, Cardiopulmonary disease, Osteomyelitis, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests special insoles called Orpyx Sensory Insoles to determine if they can help prevent foot ulcers in people with diabetes. The goal is to assess whether these insoles, when combined with regular care, can reduce the risk of foot sores that often affect those with diabetes. The trial also examines how these insoles impact quality of life and costs. Suitable participants have type 1 or 2 diabetes, have recently healed from a foot ulcer, and can walk at least 30 steps. Participants must wear the insoles for at least 5 hours each day. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance diabetic foot care.

What prior data suggests that the Orpyx Sensory Insole System is safe for individuals at risk for diabetic foot complications?

Research has shown that the Orpyx Sensory Insole System is generally easy to use. In a study with 40 participants, they wore the insoles for an average of 8.9 hours a day without major issues, indicating that most users found them comfortable and simple to use.

The insoles also help prevent diabetic foot ulcers, which are painful sores that can lead to serious health issues if untreated. The system's sensors monitor foot pressure and provide feedback to help reduce these risks.

Overall, evidence suggests that the Orpyx Sensory Insole System is safe, with no major side effects reported, making it a promising choice for those seeking to prevent diabetes-related foot problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for diabetic foot, which often focus on wound care and pressure relief, the Orpyx Sensory Insole System introduces a novel approach by using sensor technology to monitor pressure and provide real-time feedback. This innovative system aims to prevent foot ulcers before they develop by alerting users to adjust their posture or activity based on the pressure data. Researchers are excited about this technology because it has the potential to significantly reduce the risk of foot ulcers, a common and serious complication for people with diabetes, by addressing the issue proactively rather than reactively.

What evidence suggests that the Orpyx Sensory Insole System is effective for reducing diabetic foot complications?

Studies have shown that the Orpyx Sensory Insole System can significantly reduce the risk of foot ulcers in people with diabetes. One study found that patients using these insoles developed fewer foot ulcers. In this trial, participants in the intervention arm will use the Orpyx Sensory Insole System, which monitors pressure on the soles and provides feedback to prevent damage. This system can also save money by reducing the need for treatments related to foot problems. Overall, evidence suggests that these insoles effectively prevent diabetic foot ulcers. ^{1 2 3 6 7}

Who Is on the Research Team?

Caitlin Hicks, MD

Principal Investigator

John's Hopkins University

Are You a Good Fit for This Trial?

This trial is for people with type 1 or type 2 diabetes who have recently healed a foot ulcer caused by nerve damage, can walk at least 30 steps (with or without a cane/walker), have good blood flow in their legs, and are willing to wear special insoles daily. They must also understand the study requirements.

Inclusion Criteria

Qualification as a high-risk participant with recent history (<12 months) of healed diabetic neuropathic ulceration on weight-bearing surface of one or both feet

ABI > 0.6 or TBI > 0.4 or palpable pulses or evidence of healing in last 2 months; if ABI < 0.4, vascular lab studies reviewed by study PI and co-I vascular surgeon

I have been diagnosed with neuropathy after a monofilament test.

Exclusion Criteria

I have severe difficulty flexing my foot upward.

Dementia

Psychiatric illness or social situations limiting study compliance

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Orpyx Sensory Insoles as an adjunct to standard care to reduce plantar ulceration incidence

12 months

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Orpyx Sensory Insole System

Trial Overview

The study compares standard diabetic foot care alone versus standard care plus Orpyx Sensory Insoles—wearable devices that monitor pressure and activity—to see if they help prevent new foot ulcers in high-risk individuals.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Group II: Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

Orpyx Medical Technologies Inc.

Lead Sponsor

Trials

3

Recruited

580+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Citations

1.

orpyx.com

orpyx.com/resources/evaluating-the-effectiveness-of-plantar-sensory-insoles-and-remote-patient-monitoring-for-early-intervention-in-diabetic-foot-ulcer-prevention-in-patients-with-peripheral-neuropathy

Evaluating the Effectiveness of Plantar Sensory Insoles ...

Patient case series showed of the 40 participants provided with the sensory insole system, average daily use was 8.9 hours per day, and remained steady over ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11085305/

A Multi-Faceted Digital Health Solution for Monitoring and ...

Sensory insole data enabled patient-facing biofeedback to cue active plantar offloading in response to sustained high plantar pressures, and RPM ...

3.

orpyx.com

orpyx.com/

Orpyx | Extending healthspan for people living with diabetes

The Orpyx Sensory Insole system with remote patient monitoring helps reduce the risk of foot complications by monitoring plantar pressure, adherence, ...

4.

orpyx.com

orpyx.com/payers

Diabetic Foot Ulcers are Common, Costly, and Preventable

The Orpyx Sensory Insole system captures the most robust plantar data set including pressure, temperature, adherence, and step count. Randomized Controlled ...

5.

orpyx.com

orpyx.com/resources/cost-effectiveness-of-smart-insoles-in-preventing-ulcer-recurrence-for-people-in-diabetic-foot-remission

Cost effectiveness of smart insoles in preventing ulcer ...

A peer-reviewed study showed a drastic decrease in the occurrence of foot ulcers and a substantial cost savings when using SOC + Orpyx technology.

6.

orpyx.com

orpyx.com/resources/orpyx-launches-orpyx-si-sensory-insoles-with-remote-patient-monitoring-to-prevent-diabetic-foot-ulcers

Orpyx® Launches Orpyx SI Sensory Insoles with Remote ...

The company's core product line, the Orpyx SI Sensory Insoles with remote patient monitoring, helps manage and prevent diabetic foot ulcers and ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02586519

Pressure-Sensing Insoles in the Neuropathic Ulcer ...

The SurroSense Rx system (Orpyx Medical Technologies Inc., Calgary, AB) is a smart insole system designed to aid in the prevention of plantar pressure ...