Trial Outcomes & Findings for GrafixPL PRIME Evaluation Case Study (NCT NCT03742440)

NCT ID: NCT03742440

Last Updated: 2023-07-24

Results Overview

Complete closure of the index ulcer, defined as 100% re-epithelialization as determined by the Investigator by week 12 or the End of Treatment Visit.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 40 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2023-07-24

Participant Flow

Participant milestones

Measure	GrafixPL PRIME Open-label case series to evaluate GrafixPL PRIME. All subjects receive the product. GrafixPL PRIME: GrafixPL PRIME
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

GrafixPL PRIME Evaluation Case Study

Baseline characteristics by cohort

Measure	GrafixPL PRIME n=40 feet Open-label case series to evaluate GrafixPL PRIME. All subjects receive the product. GrafixPL PRIME: GrafixPL PRIME
Age, Continuous Age of All Participants	61 years STANDARD_DEVIATION 36 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants
Race/Ethnicity, Customized Race · Caucasian	25 Participants n=5 Participants
Race/Ethnicity, Customized Race · African American	7 Participants n=5 Participants
Race/Ethnicity, Customized Race · Hispanic	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Complete closure of the index ulcer, defined as 100% re-epithelialization as determined by the Investigator by week 12 or the End of Treatment Visit.

Outcome measures

Measure	GrafixPL PRIME n=40 Participants Open-label case series to evaluate GrafixPL PRIME. All subjects receive the product. GrafixPL PRIME: GrafixPL PRIME
Number of Participants With Complete Closure of the Index Ulcer	19 Participants

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	GrafixPL PRIME n=40 Participants Open-label case series to evaluate GrafixPL PRIME. All subjects receive the product. GrafixPL PRIME: GrafixPL PRIME
Time to Closure	40.0 days Standard Deviation 20.1

SECONDARY outcome

Timeframe: 12 weeks

Population: There was no control arm in this study. Analysis of these data was separated into two groups - "closed wounds" and "not closed wounds." Wounds that closed achieved full epithelialization within the 12 week study time frame. Wounds that did not close did not achieve full epithelialization by the end of study visit.

There was no control arm in this study - everyone enrolled received treatment. Analysis of these data was separated into two groups - "closed wounds" and "not closed wounds." Wounds that closed achieved full epithelialization within the 12 week study time frame. Wounds that did not close did not achieve full epithelialization by the end of study visit.

Outcome measures

Measure	GrafixPL PRIME n=40 Participants Open-label case series to evaluate GrafixPL PRIME. All subjects receive the product. GrafixPL PRIME: GrafixPL PRIME
Total Adverse Events Closed	6 number of adverse events
Total Adverse Events Not closed	17 number of adverse events

Adverse Events

GrafixPL PRIME

Serious events: 5 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	GrafixPL PRIME n=40 participants at risk Open-label case series to evaluate GrafixPL PRIME. All subjects received the product. GrafixPL PRIME: GrafixPL PRIME
Surgical and medical procedures Hospitalized for foot-related issue	5.0% 2/40 • Number of events 2 • 12 weeks of weekly visits
Infections and infestations Non-foot related hospitalization	7.5% 3/40 • Number of events 3 • 12 weeks of weekly visits

Other adverse events

Measure	GrafixPL PRIME n=40 participants at risk Open-label case series to evaluate GrafixPL PRIME. All subjects received the product. GrafixPL PRIME: GrafixPL PRIME
Infections and infestations All adverse events	57.5% 23/40 • Number of events 23 • 12 weeks of weekly visits

Additional Information

Lawrence Lavery, DPM, MPH

UT Southwestern Medical Center at Dallas

Phone: 214-645-0544

Email: Larry.Lavery@UTSouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place