TruSkin®: Study for the Treatment of Chronic Diabetic Foot Ulcers

Study Overview
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Brief Summary
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The purpose of this study is to compare the clinical outcomes of TruSkin® and an Active Comparator in patients with chronic diabetic foot ulcers.

Official Title
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A Multicenter, Randomized, Single-Blind Study Comparing the Clinical Outcomes of TruSkin® and an Active Comparator for the Treatment of Chronic Diabetic Foot Ulcers

Conditions
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Diabetic Foot Ulcers

Intervention / Treatment
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* Other: TruSkin®
* Other: Wound Cover


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 18 years and 80 years of age inclusive, as of the date of screening Confirmed diagnosis of Type 1 or Type 2 Diabetes An Index Ulcer that is chronic (defined as present for > 4 weeks, but not present for more than 52 weeks at the Screening Visit) Index Ulcer is located below the malleolus The Index Ulcer is a Diabetic Foot Ulcer (DFU) greater than 3 cm2, inclusive, at the Screening Visit The longest length and longest width measurements for the Index Ulcer are no less than 1 cm each at the Screening Visit The Index Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule Wound is free of necrotic debris Patient has adequate circulation to the foot as documented by ABI or TBI Exclusion Criteria: Index Ulcer is of non-diabetic pathophysiology Gangrene is present on any part of the affected foot Index Ulcer is over a Charcot deformity Patient is currently receiving dialysis or planning to go on dialysis Patient has a glycated hemoglobin A1c (HbA1c) level of >12% Chronic oral steroid use >7.5 mg daily for longer than 3 months at the time of screening Patient is receiving IV corticosteroids, immunosuppressive or cytotoxic agents at the time of screening Requiring intravenous (IV) antibiotics to treat the index wound infection at the time of screening Patient has an ulcer within 5 cm of the Index Ulcer identified for study consideration Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS) Current evidence of cellulitis, or other evidence of infection including fever or pus drainage from the wound site Current evidence of osteomyelitis or history of osteomyelitis within 30 days of screening Patient has active malignancy other than non-melanoma skin cancer Patient's Index Ulcer has decreased by ≥ 20% during 1-week screening period Patient's random blood sugar is > 450 mg/dl at screening Patient is unable to properly off-load the index wound as a part of standard of care Patient has untreated alcohol or substance abuse at the time of screening Pregnant women and women who are breastfeeding Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 30 days of screening Patient has had within the last 30 days, or is currently undergoing, or is planning for wound treatments with growth factors, living skin, dermal substitutes or other advanced biological therapies Patient is an employee, or an immediate family member of an employee, of the sponsor company or site research staff conducting the study Patients who have already been randomized in Protocol 351 at any center may not be considered for screening or for re-entry into the trial at any center, even after the End of Study Visit Patients with a history of poor compliance, or an unwillingness or inability to adhere to the requirements of the protocol

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: TruSkin®<br>Cryopreserved skin allograft | Other: TruSkin®<br> <br> |
| Active Comparator: Wound Cover<br>Active Comparator for Diabetic Foot Ulcers | Other: Wound Cover<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients that achieve a 50% or greater reduction in wound size by 8 weeks |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients that achieve complete closure of the index wound by 12 weeks |  | 12 weeks | 
| Proportion of Patients that achieve a 50% or greater reduction in wound size by 4 weeks |  | 4 weeks | 
| Time to initial wound closure |  | Up to 84 days | 
| Number of product applications |  | Up to 84 days | 
| Number of AEs |  | Up to 84 days | 
| Number of patients with worsening of index wound defined by ≥ 50% increase in wound size |  | Up to 84 days |