GrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers

Study Overview
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Brief Summary
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The objective of the study is to compare the efficacy of weekly GrafixPRIME® administration to an Active Comparator in patients with chronic DFUs in a randomized, single-blind study.

Official Title
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A Multicenter, Randomized, Single-Blind Study Comparing the Efficacy of GrafixPRIME® to Active Comparator for the Treatment of Chronic Diabetic Foot Ulcers

Conditions
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Foot Ulcer, Diabetic

Intervention / Treatment
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* Other: GrafixPRIME®
* Procedure: Dressing Application
* Device: Off-loading (walking boot)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 or Type 2 Diabetes Chronic ulcer (present for ≥4 weeks, but not more than 52 weeks) Index ulcer located below the malleoli on the plantar or dorsal surface of the foot Index ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone or joint capsule Adequate circulation to the foot (documented by ABI or TBI) Exclusion Criteria: Gangrene present on affected foot Index ulcer is over a Charcot deformity Patient is receiving dialysis Patient has 2 or more previous amputations Patient has HbA1c >12% or random blood sugar >450 mg/dl Chronic oral steroid use Use of IV corticosteroid, immunosuppressive, or cytotoxic agents IV antibiotics Another ulcer within 5cm of the Index ulcer Cellulitis, evidence of infection, or osteomyelitis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GrafixPRIME®<br>GrafixPRIME® is cryopreserved human placental membrane Patients will be fitted with off-loading devices | Other: GrafixPRIME®<br>* Human tissue, Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing.<br>Device: Off-loading (walking boot)<br>* Patients will be fitted for an off-loading device (walking boot) and agree to comply with use of the device during the course of the study<br>|
| Active Comparator: Active Comparator<br>Wound cover, Dressing Application Patients will be fitted with off-loading devices | Procedure: Dressing Application<br>* Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing.<br>Device: Off-loading (walking boot)<br>* Patients will be fitted for an off-loading device (walking boot) and agree to comply with use of the device during the course of the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete closure of index wound |  | Up to Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to wound closure |  | Up to Day 56 | 
| Proportion of patients that achieve a 50% reduction or greater in wound size |  | Day 28 | 
| Number of product applications |  | Up to Day 56 | 
| Number of Adverse Events |  | Up to Day 56 | 
| Number of patients with worsening of wound by ≥50% increase in size |  | Up to Day 56 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Grafix