Using a special cast to heal diabetic foot ulcers
Total Contact Soft Cast in Diabetic Foot Ulcers
This study tests whether a special soft cast can help heal diabetic foot ulcers better than regular methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT04210089 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with diabetic foot ulcers who can comply with weekly follow-up visits.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Minneapolis, Minnesota
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.