Diabetes Mellitus Clinical Trial
Official title:
Total Contact Soft Cast in Diabetic Foot Ulcers
To determine the effectiveness, compliance, patient tolerance, ease of use and safety of total contact soft cast in diabetic foot ulcers.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | October 1, 2024 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete Healing Rates | Complete healing is defined as complete epithelization of the ulcer. Outcome will be reported in days. | 16 weeks | |
Secondary | Patient Compliance with Use of the Total Contact Soft Cast | The percentage of patients who use the total contact soft cast until complete healing or 16 weeks of treatment will be calculated. | 16 weeks | |
Secondary | Patient Complications | The percentage of patients who need to stop using the soft case due to complications will be calculated. | 16 weeks |
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