Using a special cast to heal diabetic foot ulcers
Official title: Total Contact Soft Cast in Diabetic Foot Ulcers
Run by University of Minnesota · NCT04210089 · Data updated 2026-11-12
This study tests whether a special soft cast can help heal diabetic foot ulcers better than regular methods.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Status | Recruiting |
| Started | October 13, 2020 |
| Main results expected | October 1, 2027 |
| Study ends | October 1, 2027 |
| Registry record updated | October 2, 2026 |
| Trial ID | NCT04210089 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with diabetic foot ulcers who can comply with weekly follow-up visits.
✕Probably not a fit
Patients with allergies to key materials used in the cast or those unable to consent or comply with treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness and safety of a total contact soft cast for treating diabetic foot ulcers compared to traditional offloading methods. Participants will receive a customized cast that includes various layers of materials designed to support the healing process. The study will also assess patient compliance, tolerance, and ease of use of the cast, with some patients potentially using a removable cam boot. Weekly follow-ups will be conducted to monitor progress and adjust treatment as necessary.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and comfortable treatment option for patients with diabetic foot ulcers.
How similar studies have gone: While there have been various approaches to treating diabetic foot ulcers, the specific use of a total contact soft cast is less commonly studied, making this a novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Any adult with a diabetic foot ulcer 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
Where it's running
-
University of Minnesota
Minneapolis, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Joseph Schuster, DPM — University of Minnesota
- Study coordinator: Joseph Schuster
- Email: schus122@umn.edu
- Phone: 612-273-9400
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using human placental membrane wraps with regular wound care to help heal stubborn diabetic foot and venous leg ulcers
This trial tests whether adding one of four human placental membrane wraps to standard wound care helps people with nonhealing diabetic foot or venous leg ulcers heal faster and more completely than standard care alone.
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Evaluating new treatments for nonhealing diabetic foot and venous leg ulcers.
This study is testing whether new treatments for stubborn diabetic foot and leg ulcers can help people heal better when combined with standard care compared to just standard care alone.
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Human placental membrane products plus standard care for nonhealing diabetic foot and venous leg ulcers
This trial will try human placental membrane products together with standard wound care to help adults whose diabetic foot ulcers or venous leg ulcers have not healed.
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Single-layer placental graft plus standard care for stubborn diabetic foot ulcers
This trial will try a single-layer placental-based graft together with usual wound care for adults whose diabetic foot ulcers did not heal after standard treatment in an earlier trial.
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Wound matrix treatments for nonhealing diabetic foot ulcers
This trial will test whether adding special wound matrix products to standard care helps close hard-to-heal diabetic foot ulcers in adults with type 1 or 2 diabetes within 12 weeks.
-
Evaluating human placental membrane products for treating nonhealing diabetic foot and venous leg ulcers
This study is testing whether using human placental products along with regular care can help people with stubborn diabetic foot and leg ulcers heal better.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.