🏛️ Verified NIH Record • Updated 2025-12-09
Total Contact Soft Cast in Diabetic Foot Ulcers (NCT04210089)
🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: University of Minnesota
🩺 Plain-English Summary (8th-Grade Level)
To determine the effectiveness, compliance, patient tolerance, ease of use and safety of total contact soft cast in diabetic foot ulcers.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (1 items) and avoid the listed exclusions (7 items).
Location: University of Minnesota — Minneapolis, Minnesota
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Allergy to Calamine or Zinc oxide
- Inability to have leg wrapped
- Inability to be seen weekly or as needed
- Unable or unwilling to consent
- Prisoners
- Persons lacking capacity to consent
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of Minnesota — Minneapolis, Minnesota
💰 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.