Characterization of AmnioExcel Plus in Two Treatment Paradigms
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|ClinicalTrials.gov Identifier: NCT04233580|
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : July 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcer||Device: Amnio Excel + weekly Device: Amnio Excel + max every 2 weeks||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Characterization of AmnioExcel Plus in Two Treatment Paradigms|
|Actual Study Start Date :||July 9, 2020|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||June 1, 2022|
Active Comparator: Weekly AmnioEXCEL+ group
AmnioEXCEL+ will be applied weekly at study visits
Device: Amnio Excel + weekly
Amnio Excel + weekly
Active Comparator: PRN AmnioEXCEL+ group
AmnioEXCEL+ will be applied maximum every 2 weeks (PRN, in the case that the wound requires debridement at a visit not intended for AE+ application, the wound will be treated as SOC)
Device: Amnio Excel + max every 2 weeks
Amnio Excel + max every 2 weeks
- Ekare wound measurement application to track wound healing. [ Time Frame: 12 weeks ]Incidence of healing at 12 weeks, tracked by wound measuring camera/app which performs a 3D measurement. This tracks rate of healing.
- Ekare wound measurement application to track wound percent volume reduction [ Time Frame: 12 weeks ]Percent of volume reduction at 12 weeks, tracked by wound measuring camera/app which performs a 3D measurement and calculates the volume.
- Ekare wound measurement application to track wound percent area reduction [ Time Frame: 12 weeks ]Percent of area reduction at 12 weeks, tracked by wound measuring camera/app which performs a 3D measurement and calculates the area.
- Hyperspectral imaging camera to track wound bed perfusion. [ Time Frame: 12 weeks ]Hyperspectral imaging camera is used to track wound bed perfusion by calculating oxygenation and deoxygenation of the wound bed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04233580
|Contact: Tara Kristofemail@example.com|
|Contact: Debby Noblefirstname.lastname@example.org|
|United States, Texas|
|UT Southwestern Medical Center at Dallas||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Tara Kristof 214-648-9007 Tara.Kristof@UTSouthwestern.edu|
|Principal Investigator:||Lawrence Lavery, DPM MPH||UT Southwestern Medical Center|