GrafixCORE®: Open-Label Study to Evaluate the Safety and Efficacy of GrafixCORE® for Complex Diabetic Foot Wounds

Study Overview
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Brief Summary
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A multicenter, open-label, single-arm study to evaluate the safety and efficacy of GrafixCORE® for the treatment of complex diabetic foot wounds with exposed tendon and/or bone.

Official Title
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A Multicenter, Open-label, Single-Arm Study to Evaluate the Safety and Efficacy of GrafixCORE® for the Treatment of Complex Diabetic Foot Wounds With Exposed Tendon and/or Bone

Conditions
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Complex Diabetic Foot Wounds

Intervention / Treatment
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* Other: Grafix®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 18 years and 85 years of age inclusive, as of the date of screening Confirmed diagnosis of Type I or Type II Diabetes Index wound graded in the Texas Classification System as Grade II-III, Stage A or C (without active infection) Wound is located on the foot below the malleoli Wound accommodates up to three (3) 5 cm x 5 cm pieces of GrafixCORE® that completely cover the wound Patient's wound extends through the dermis and into subcutaneous tissue with evidence of exposed muscle, tendon, bone, and/or joint capsule Patient has adequate circulation to the foot as documented by either: Ankle Brachial Index (ABI) ≥ 0.5 and ≤ 1.2, or In patients with non-compressible ankle vessels, a Toe BP ≥ 40 mmHg or TcPO2 > 30 mmHg, or Skin perfusion pressure > 30 mmHg Exclusion Criteria: Index Wound is of non-diabetic pathophysiology Gangrene is present on any part of the affected foot Index Wound is over a Charcot deformity The longest dimension of the Index Wound exceeds 15 cm at the Baseline Visit Patient has a glycated hemoglobin A1 (HbA1c) level of >14% Requiring intravenous (IV) antibiotics to treat the index wound infection at enrollment Patient has a wound within 15cm of the Index Ulcer identified for study consideration Patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS) Current evidence of osteomyelitis, cellulitis, or other evidence of infection including fever or pus drainage from the wound site Patient has active malignancy other than non-melanoma skin cancer Patient's random blood sugar is >450 mg/dl at screening Patient has untreated alcohol or substance abuse at the time of screening, or is deemed to be non-adherent to the protocol by the Investigator Pregnant women Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 30 days of screening Patient has allergy to primary or secondary dressing materials used in this trial Patient has had within the last 14 days, or is currently undergoing, or is planning for wound treatments with enzymes, growth factors, living skin, dermal substitutes or other advanced biological therapies In the opinion of the Investigator, the patient is unsuitable for participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Open-Label<br>Grafix®: Cryopreserved Placental Membrane | Other: Grafix®<br>* The treatment indication is for complex diabetic foot wounds with exposed tendon and/or bone that can accommodate up to three 5cm x 5cm pieces of Grafix®. Patients will be treated for up to 16 weeks. Patients will be evaluated at screening and then weekly throughout the study or until wound closure.<br>* Other names: Allograft Tissue;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 100% granulation of wound as determined by the investigator |  | Up to 16 weeks after the Initial Treatment Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to 100% granulation |  | Up to 16 weeks after the Initial Treatment Visit | 
| Number of applications of Grafix® |  | Up to 16 weeks after the Initial Treatment Visit | 
| Measurement of percent wound area reduction as determined by the investigator |  | Up to 16 weeks after the Initial Treatment Visit | 
| Closure of wound defined by 100% re-epithelialization |  | Up to 16 weeks after the Initial Treatment Visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DFU, Complex Wound, Diabetic Foot Ulcer, GrafixCORE, Exposed tendon, Exposed bone, Allograft tissue