At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Characterization of AmnioExcel Plus in Two Treatment Paradigms
In Brief
A clinical study evaluating Amnio Excel + weekly and Amnio Excel + max every 2 weeks for Diabetic Foot Ulcer. Completed, enrolled 40 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Amnio Excel + weekly
Amnio Excel + max every 2 weeks