The Goal of this study is to evaluate the wound volume reduction rate and the time to closure when using Vendaje to manage diabetic wounds. The participants will be treated weekly for up to 12 weeks. The data will be compared to retrospective Standard of care data from similarly controlled studies
Patients will be recruited by the site PIs and will be educated on the details of the study through the use of a detailed And IRB approved informed consent. They must meet the inclusion/exclusion criteria which includes appropriate testing for perfusion and control of diabetes. Once accepted a screening visit without Vendaje treatment but SOC treatment to determine if closure with SOC will be adequate. If the SOC screen fails a threat protocol begins for up to 12 weeks or closure. data will be collected using digital planimetry and also recorded in a research binder with CRFs provided. A final visit 2 weeks after closure or end of 12 weeks will provided information related to wound recurrence.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Dehydrated Human Amniotic Membrane
Time Closure in Diabetic foot ulcers Managed with Vendaje
The effect on closure rates of diabetic foot ulcers when Vendaje is applied to the wound bed
Time frame: 12 weeks of treatment
Reduction of wound volume in diabetic foot ulcers treated with Vendaje
Effect of Venaje on the volume reduction of diabetic foot ulcers when Vendaje is applied.
Time frame: 12 weeks of treatment
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