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Completed

NCT Number: NCT03742440

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.

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Key information

Conditions

Diabetic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GrafixPL PRIME

Biological

GrafixPL PRIME

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time to Closure

    Time frame: 12 weeks

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • Osiris Therapeutics

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 15, 2018
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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