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GrafixPL PRIME Evaluation Case Study

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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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GrafixPL PRIME
Hide 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
Arm/Group Title GrafixPL PRIME
Hide 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
Hide 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%
1.Primary Outcome
Title Number of Participants With Complete Closure of the Index Ulcer
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GrafixPL PRIME
Hide 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
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GrafixPL PRIME
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Time Frame 12 weeks of weekly visits
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GrafixPL PRIME
Hide 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%)    
Hide 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
Hide 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.
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
Layout table for Results Point of Contact information
Name/Title: Lawrence Lavery, DPM, MPH
Organization: UT Southwestern Medical Center at Dallas
Phone: 214-645-0544
EMail: Larry.Lavery@UTSouthwestern.edu
Layout table for additonal information
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