WIREDUP: Wearable Insoles for Recurrent Diabetic Ulcer Prevention (NCT05950659)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Johns Hopkins Hospital — Baltimore, Maryland
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Johns Hopkins Hospital — Baltimore, Maryland
📞 Contact the Study Coordinator
Phone: (855) 996-7799
Email: emily.bray@orpyx.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Diabetes
- Northern Manhattan Study of Metabolism and Mind — New York, New York
- The Effect of Grocery Support Dose on Food Insecurity and Disease Control Among Covered California Members With Diabetes or Hypertension — San Francisco, California
- Eversense® Non-adjunctive Use Post Approval Study — Los Angeles, California
- Evaluating the Health Outcomes of the Joslin Why WAIT Program — Boston, Massachusetts
- Community Engagement Alliance Against Disparities — Washington D.C., District of Columbia
- Meta-Analyses of the Effect of Plant Protein Versus Animal Protein on Cardiometabolic Risk — Toronto, Ontario
Explore by condition: All Diabetes clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.