Clinical trial NCT03742440: GrafixPL PRIME Evaluation Case Study
Official title: GrafixPL PRIME Evaluation Case Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Foot Ulcer
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Osiris Therapeutics
First posted: 2018-11-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Eligibility 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

Primary outcomes:
measure: Number of Participants With Complete Closure of the Index Ulcer
timeFrame: 12 weeks
Secondary outcomes:
measure: Time to Closure
timeFrame: 12 weeks
measure: Total Adverse Events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Lawrence Lavery, DPM MPH
role: PRINCIPAL_INVESTIGATOR
References: