GrafixPL PRIME Evaluation Case Study

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Biological: GrafixPL PRIME

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: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center at Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: GrafixPL PRIME; Open-label case series to evaluate GrafixPL PRIME. All subjects receive the product.	Biological: GrafixPL PRIME; GrafixPL PRIME

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Closure		12 weeks
Total Adverse Events	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.	12 weeks

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Osiris Therapeutics
• Investigators: Principal Investigator: Lawrence Lavery, DPM MPH, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2018
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: November 9, 2018
• First Submitted That Met QC Criteria: November 13, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: 022018-035

Drug and device information, study documents

• 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