Characterization of AmnioExcel Plus in Two Treatment Paradigms

Completed · Not applicable

Conditions studied: Diabetic Foot Ulcer

In brief

The Investigators plan to evaluate healing in two cohorts of patients with diabetic foot wounds (n=20) that receive optimal treatment including serial wound debridement and off-loading with a boot or postop shoe and AmnioEXCEL+. In one cohort, AmnioEXCEL+ will be applied weekly at study visits and in the second cohort, 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). In addition, the Investigators will collect data on other potential confounding factors that could affect healing such as antibiotic, anti-fungal and anti-infective medications, tobacco, comorbidities, diabetes control, infection, perfusion, and activity. Wound healing, including wound size and adverse events will be evaluated.

Key facts

Study ID
NCT04233580
Run by
University of Texas Southwestern Medical Center
People needed
40
Starts
2020-07-09
Expected to finish
2021-04-06
Last updated by the study team
2023-07-24

Who can join

Age: 21 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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