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GrafixPL PRIME Evaluation Case Study

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ClinicalTrials.gov Identifier: NCT03742440
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : January 7, 2019
Sponsor:
Collaborator:
Osiris Therapeutics
Information provided by (Responsible Party):
Larry Lavery, University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Biological: GrafixPL PRIME Phase 4

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: GrafixPL PRIME Evaluation Case Study
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
GrafixPL PRIME
Open-label case series to evaluate GrafixPL PRIME. All subjects receive the product.
Biological: GrafixPL PRIME
GrafixPL PRIME




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742440


Contacts
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Contact: Tara Kristof 214-648-9007 Tara.Kristof@UTSouthwestern.edu
Contact: Debby Noble 214-648-8686 Debby.Noble@UTSouthwestern.edu

Locations
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United States, Texas
UT Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Tara Kristof    214-648-9007    Tara.Kristof@UTSouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Osiris Therapeutics
Investigators
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Principal Investigator: Lawrence Lavery, DPM MPH UT Southwestern Medical Center

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Responsible Party: Larry Lavery, Professor and Director of Research, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03742440     History of Changes
Other Study ID Numbers: 022018-035
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019

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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
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases