Efficacy and Safety Study in 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 determine the safety and efficacy of Dermal-LSR plus Standard of Care (SOC) for the treatment of diabetic foot ulcers (DFU)in comparison to the treatment to SOC alone.

Detailed Description
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The study is a pivotal, prospective, randomized, controlled, open-label, multi-center study that will evaluate the effectiveness and safety of topically applied Dermal-LSR in chronic DFUs.

Official Title
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Pivotal Study to Evaluate the Efficacy and Safety of Dermal-Living Skin Replacement (Dermal-LSR) in the Treatment of Chronic Diabetic Foot Ulcers

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: Dermal - Living Skin Replacement (Dermal - LSR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has signed a written informed consent prior to the first study intervention Is at least 18 and <85 years of age Has one or more diabetic foot ulcers on the target limb, with only one marked for the study (target ulcer). It must have the following characteristics:Plantar; Grade 2 per Curative Health Services Classification; Non-infected; Neuropathic; Non-malignant; At least 1.0-25cm^2 post-debridement; Present for at least 6 weeks Has Type I or II Diabetes Mellitus with an HBA1c between 6-10% Has a maximum fasting blood glucose level of 13.8 mmol/L An ankle-brachial systolic pressure index between 0.7 and 1.3 If female and of childbearing potential has a negative serum pregnancy test and is neither breastfeeding or intending to become pregnant during the study Able and willing to attend the scheduled visits and comply with study procedures. Exclusion Criteria: Known or suspected disease of the immune system Active or untreated malignancy or active, uncontrolled connective tissue disease Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before enrollment Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement Has undergone revascularization procedure aimed at increasing blood flow in the treatment target limb < 4 weeks prior to enrollment Active febrile illness AST, ALT, ALP >3x the normal upper limit Serum Creatinine >2x the normal upper limit Osteomyelitis Active Charcot Use of any topical treatments other than SOC (standard of care)at the time of enrollment Enrollment in any investigational clinical trial within 30 days of the screening visit Known or suspected hypersensitivity to any study product components Recent or current history of alcohol or drug abuse Any condition, which in the opinion of the Investigator, would interfere with the evaluation of the study product or poses a health risk to the subject All site personnel directly affiliated with this study and their immediate families

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 84 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Dermal - Living Skin Replacement (Dermal - LSR)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the efficacy and safety of Dermal-LSR plus Standard of Care (SOC) for the treatment of chronic diabetic foot ulcers in comparison to treatment with SOC alone. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Foot Ulcer, Diabetes Mellitus, Debridement, Dermal-LSR, Standard of Care