GrafixPL PRIME Evaluation Case Study

Status Completed

Clinical Trial 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.

Clinical Trial Description

Screening and Enrollment: - Review and sign the Informed Consent and HIPAA Authorization - Review the inclusion and exclusion criteria If the subject qualifies for the study, they will participate in the following procedures (weekly visits, +/-4 days): Visit 0: - Demographics (such as age, gender, race or ethnicity) - Medical/Surgical and Social History, Current Antibiotics. - Laboratory Results - Vascular - ABI - Neurological evaluation - Monofilament and VPT - Vitals - Sitting blood pressure and Pulse rate, Height/Weight, and BMI - Wound debridement - eKare - Wound imaging measurement - Application of GrafixPL PRIME - Current Antibiotics - Offloading - Adverse Events - Source documentation Visits 1 - 11: - Wound debridement - eKare - Wound imaging measurement - Application of GrafixPL PRIME - Current Antibiotics - Offloading - Adverse Events - Source documentation Visit 12/End of Study (EOS) Visit: - Wound debridement - eKare - Wound imaging measurement - Current Antibiotics - Offloading - Adverse Events - Source documentation (End of Study will occur on the date the subject is healed) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03742440
Study type	Interventional
Source	University of Texas Southwestern Medical Center
Contact
Status	Completed
Phase	Phase 4
Start date	November 20, 2018
Completion date	March 1, 2020

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