GrafixPL PRIME Evaluation Case Study

• ClinicalTrials.gov Identifier: NCT03742440
• Recruitment Status: Completed
• First Posted: November 15, 2018
• Results First Posted: July 30, 2020
• Last Update Posted: July 30, 2020
• Sponsor: University of Texas Southwestern Medical Center
• Collaborator: Osiris Therapeutics
• Information provided by (Responsible Party): Larry Lavery, University of Texas Southwestern Medical Center

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Diabetic Foot Ulcer
• Intervention: Biological: GrafixPL PRIME
• Enrollment: 40

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	GrafixPL PRIME
Arm/Group Description	Open-label case series to evaluate GrafixPL PRIME. All subjects receive the product. GrafixPL PRIME: GrafixPL PRIME
Period Title: Overall Study
Started	40
Completed	40
Not Completed	0

Baseline Characteristics

Arm/Group Title		GrafixPL PRIME
Arm/Group Description		Open-label case series to evaluate GrafixPL PRIME. All subjects receive the product. GrafixPL PRIME: GrafixPL PRIME
Overall Number of Baseline Participants		40
Overall Number of Units Analyzed; Type of Units Analyzed: Feet		40
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
Age of All Participants	Number Analyzed	40 participants
		61 (36)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	40 participants
	Female	8 20.0%
	Male	32 80.0%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
Race	Number Analyzed	40 participants
	Caucasian	25 62.5%
	African American	7 17.5%
	Hispanic	8 20.0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Complete Closure of the Index Ulcer
Description	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.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	GrafixPL PRIME
Arm/Group Description:	Open-label case series to evaluate GrafixPL PRIME. All subjects receive the product. GrafixPL PRIME: GrafixPL PRIME
Overall Number of Participants Analyzed	40
Measure Type: Count of Participants; Unit of Measure: Participants
	19 47.5%

2. Secondary Outcome

Title	Time to Closure
Description	[Not Specified]
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	GrafixPL PRIME
Arm/Group Description:	Open-label case series to evaluate GrafixPL PRIME. All subjects receive the product. GrafixPL PRIME: GrafixPL PRIME
Overall Number of Participants Analyzed	40
Mean (Standard Deviation); Unit of Measure: days
	40.0 (20.1)

3. Secondary Outcome

Title	Total Adverse Events
Description	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.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title		GrafixPL PRIME
Arm/Group Description:		Open-label case series to evaluate GrafixPL PRIME. All subjects receive the product. GrafixPL PRIME: GrafixPL PRIME
Overall Number of Participants Analyzed		40
Measure Type: Number; Unit of Measure: number of adverse events
Closed	Number Analyzed	19 participants
		6
Not closed	Number Analyzed	21 participants
		17

Adverse Events

Time Frame	12 weeks of weekly visits
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	GrafixPL PRIME
Arm/Group Description	Open-label case series to evaluate GrafixPL PRIME. All subjects received the product. GrafixPL PRIME: GrafixPL PRIME
All-Cause Mortality
	GrafixPL PRIME
	Affected / at Risk (%)
Total	0/40 (0.00%)
Serious Adverse Events
	GrafixPL PRIME
	Affected / at Risk (%)	# Events
Total	5/40 (12.50%)
Infections and infestations
Non-foot related hospitalization †	3/40 (7.50%)	3
Surgical and medical procedures
Hospitalized for foot-related issue †	2/40 (5.00%)	2
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	GrafixPL PRIME
	Affected / at Risk (%)	# Events
Total	23/40 (57.50%)
Infections and infestations
All adverse events † [1]	23/40 (57.50%)	23
† Indicates events were collected by systematic assessment; [1] Includes all reinfections of the foot, pneumonia, antibiotics for any reason not including foot infection, and cutaneous abscess on non-study limb.

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Lawrence Lavery, DPM, MPH
• Organization: UT Southwestern Medical Center at Dallas
• Phone: 214-645-0544
• EMail: Larry.Lavery@UTSouthwestern.edu

• Responsible Party: Larry Lavery, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT03742440
• Other Study ID Numbers: 022018-035
• First Submitted: November 9, 2018
• First Posted: November 15, 2018
• Results First Submitted: July 13, 2020
• Results First Posted: July 30, 2020
• Last Update Posted: July 30, 2020