GrafixPL PRIME Evaluation Case Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-20

Study Completion Date

2020-03-01

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.

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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)

Conditions

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Diabetic Foot Ulcer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GrafixPL PRIME

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

Group Type OTHER

GrafixPL PRIME

Intervention Type BIOLOGICAL

GrafixPL PRIME

Interventions

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GrafixPL PRIME

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No