GrafixPL PRIME Evaluation Case Study

NCT03742440 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 022018-035
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time to Closure

  12 weeks

• Total Adverse Events

  12 weeks

Study Arms (1)

GrafixPL PRIME

OTHER

Open-label case series to evaluate GrafixPL PRIME. All subjects receive the product.

Biological: GrafixPL PRIME

Interventions

GrafixPL PRIME BIOLOGICAL

GrafixPL PRIME

GrafixPL PRIME

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide informed consent
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Osiris Therapeutics: collaborator

Study Sites (1)

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Lawrence Lavery, DPM, MPH
• Organization: UT Southwestern Medical Center at Dallas

Larry.Lavery@UTSouthwestern.edu

214-645-0544

Study Officials

• Lawrence Lavery, DPM MPH

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director of Research

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 15, 2018
• Study Start: November 20, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: July 24, 2023
• Results First Posted: July 30, 2020

Record last verified: 2023-07

Locations

US (1)