drugset / Trial / NCT03742440

GrafixPL PRIME Evaluation Case Study

NCT03742440 ↗

NaSingle-groupOpen-labelTreatment

Summary

The investigators plan to evaluate healing in a cohort of patients with chronic wounds (n=40) that receive optimal treatment including serial wound debridement and off-loading with total contact casts or a boot and GrafixPL PRIME. In addition, the investigators will collect data on other potential confounding factors that could affect healing such as medications, tobacco, nutrition, comorbidities, diabetes control, infection, perfusion, and activity. Wound healing, including wound size and adverse events will be evaluated. The objective of this study is to understand the use of this product to evaluate wound healing in 40 patients.

Timeline

Start
2018-11-20
Primary completion
2020-03-01
Completion
2020-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject GrafixPL PRIME Unknown — —

Indications