GrafixPL PRIME Evaluation Case Study

Diabetic Foot Ulcer Clinical Trial

Official title:

GrafixPL PRIME Evaluation Case Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03742440
• Other study ID #: 022018-035
• Status: Completed
• Phase: Phase 4
• Start date: November 20, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: July 2023
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer

Intervention

Biological:
• GrafixPL PRIME
GrafixPL PRIME

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center at Dallas	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Osiris Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to Closure		12 weeks
Secondary	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