GrafixPL PRIME Evaluation Case Study

Study Overview
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Brief Summary
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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
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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)

Official Title
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GrafixPL PRIME Evaluation Case Study

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Biological: GrafixPL PRIME


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |