NCT03742440

GrafixPL PRIME Evaluation Case Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
BIOLOGICAL	GrafixPL PRIME	GrafixPL PRIME

Timeline

• Start date: 2018-11-20
• Primary completion: 2020-03-01
• Completion: 2020-03-01
• First posted: 2018-11-15
• Last updated: 2023-07-24
• Results posted: 2020-07-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study