A Controlled Prospective Treatment Study to Evaluate the Efficacy of

Status Not yet recruiting

Clinical Trial Summary

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

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06150209
Study type	Interventional
Source	BioStem Technologies
Contact	John Starinski, DPM
Phone	5702365300
Email	jstarinski@biostemtech.com
Status	Not yet recruiting
Phase	N/A
Start date	January 15, 2024
Completion date	June 15, 2025

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See also
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A Controlled Prospective Treatment Study to Evaluate the Efficacy of Vendaje.

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms