Sponsor:
University of Minnesota
Code:
NCT04210089
Conditions
Diabetic Foot Ulcer
Diabetes Mellitus
Foot Ulcer
Foot Ulcer, Diabetic
Ulcer
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Interventions
Total Contact Soft Cast
Cam Boot
Brief summary:
Conditions
Diabetic Foot Ulcer
Diabetes Mellitus
Foot Ulcer
Foot Ulcer, Diabetic
Ulcer
Study ID
NCT04210089
Start date
Oct 13, 2020
Status verified date
Dec, 2025
Completion date
Oct 1, 2026
Anticipated
Primary completion date
Oct 1, 2026
Anticipated
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Enrollment
100 participants
Anticipated
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary purpose
Treatment
Arms
experimental: Soft Cast with a Removable Cam Boot
experimental: Soft Cast without a Removable Cam Boot
no intervention: Conventional
Interventions
Total Contact Soft Cast
Cam Boot
Primary outcome measure
Central contacts
Locations
University of Minnesota
Recruiting
Minneapolis, Minnesota, United States, 55454
Contacts
Sponsor
University of Minnesota
Last update posted
Dec 15, 2025
Last verified
Dec, 2025
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2025-12-15.