MIRODERM H2H DFU Study

Study Overview
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Brief Summary
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This study will assess the ability of MIRODERM to heal difficult diabetic foot ulcers within 12 weeks of treatment.

Detailed Description
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The primary objective of this study is to determine the number of successful complete wound closures within 12 weeks of treatment with MIRODERM Fenestrated Biological Wound Matrix. Some secondary objectives of this study include documenting the time course of wound healing and assessing changes in quality of life. The primary cohort is individuals suffering from a diabetic foot ulcer that has not been healed in the last 3 months and after at least 2 attempts with an advanced biologic. Ulcer will be between 1 and 12 cm squared, less than 5 mm deep, full thickness, below the ankle, and with no exposed bone or tendon. Subjects will be 18 or older, have Type I or II diabetes with adequate vascular profusion. Subjects will be unable to participate if they have osteomyelitis, Charcot foot, a known collagen vascular disease, are on dialyses, are immunocompromised or have an HbA1c level equal to or great than 12%. This is a single-arm study with no Independent Variables. Descriptive data to be collected will include demographics, pathology and medical history. Outcome assessments: proportion of subjects with 100% epithelialization of wound SF-36 Adverse events

Official Title
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Effectiveness of MIRODERM® Biologic Wound Matrix in the Treatment of Hard-to-Heal Diabetic Foot Ulcers

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: Biologic wound graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old or older at time of initial visit Have Type I or Type II diabetes Have a neuropathic diabetic foot ulcer with the following characteristics: Is greater than 1 cm2 and less than or equal to 12 cm2 Has failed to close following at least 2 treatments with a biologic Has been present for 90 days or longer Does not show signs of infection Is full thickness (Wagner Grade I or II) Located distal to the malleolus Depth of less than or equal to 5 mm No exposed capsule, tendon or bone No tunneling, undermining or sinus tracts Not between the toes Be willing and able to maintain required off-loading of affected limb Be willing and able to perform necessary dressing changes Have at least one of the following: An Ankle-brachial index (ABI) ≥ 0.8 TcPO2 of ≥ 30 mmHg A toe pressure of ≥ 50 mmHg Exclusion Criteria: Be pregnant or be planning to become pregnant during the study Have had a Chopart's Amputation (or higher) Have a history of bone cancer of the affected limb Be undergoing dialysis Have active osteomyelitis or be receiving treatment for osteomyelitis Be diagnosed with unstable Charcot Foot on the affected side Have an HbA1c level of ≥ 12% within the past 90 days Have another ulcer within 2 cm of the study ulcer Be immunocompromised or at risk of immunosuppression as determined by the treating investigator Have a known collagen vascular disease or connective tissue disease Have received treatment of the study ulcer with a skin substitute product or topical growth factor within the past 4 weeks Be participating in another medical research study Have a sensitivity to porcine material

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MIRODERM<br>Biologic wound graft | Device: Biologic wound graft<br>* Diabetic foot ulcer will be treated by grafting with MIRODERM Biologic Wound Matrix<br>* Other names: MIRODERM Biologic Wound Matrix treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants | Percentage of participants with healed ulcers within 12 weeks of treatment | 12 weeks |