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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

Tracking Information
First Submitted Date  ICMJE November 9, 2018
First Posted Date  ICMJE November 15, 2018
Results First Submitted Date  ICMJE July 13, 2020
Results First Posted Date  ICMJE July 30, 2020
Last Update Posted Date July 30, 2020
Actual Study Start Date  ICMJE November 20, 2018
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2020)
Number of Participants With Complete Closure of the Index Ulcer [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
wound closure/wound measurement [ Time Frame: 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2020)
  • Time to Closure [ Time Frame: 12 weeks ]
  • Total Adverse Events [ Time Frame: 12 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GrafixPL PRIME Evaluation Case Study
Official Title  ICMJE GrafixPL PRIME Evaluation Case Study
Brief 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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Foot Ulcer
Intervention  ICMJE Biological: GrafixPL PRIME
GrafixPL PRIME
Study Arms  ICMJE GrafixPL PRIME
Open-label case series to evaluate GrafixPL PRIME. All subjects receive the product.
Intervention: Biological: GrafixPL PRIME
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 1, 2020
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Able to provide informed consent
  • 18-90 years of age
  • Chronic foot ulceration below the ankle - persistent for 30 days or longer
  • Ankle Brachial Index (ABI) >0.5 (Bedside ABI is acceptable for screening purposes as the formal imaging ABI may not be resulted prior to surgery)

Exclusion Criteria:

  • Unable to provide informed consent
  • <18 or >90 years of age
  • History of poor compliance with follow-up visits
  • Gangrene
  • Untreated Osteomyelitis
  • Widespread malignancy
  • Active alcohol or substance abuse such as cocaine, heroin, or methamphetamines
  • Currently Pregnant or planning pregnancy during the course of intended participation in the study
  • Is nursing or actively lactating
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03742440
Other Study ID Numbers  ICMJE 022018-035
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Larry Lavery, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Osiris Therapeutics
Investigators  ICMJE
Principal Investigator: Lawrence Lavery, DPM MPH UT Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP