Affinity Prospective Diabetic Foot Trial Crossover Group

Study Overview
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Brief Summary
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This study is an extension of the randomized controlled trial NT-DFU-AFF-01. Subjects that were randomized to the Standard of Care group will be able to crossover to the NT-DFU-AFF-02 trial and receive Affinity fHSAM if certain criteria are met.

Detailed Description
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This study is an extension of the randomized controlled trial NT-DFU-AFF-01 in which subjects were randomized to SOC for 12 weeks or SOC and fresh hypothermically stored human amniotic membrane (Affinity; fHSAM) for 12 weeks to determine if addition of fHSAM to SOC results in faster healing of Wagner grade 1 and 2 DFUs compared to SOC alone. At 6 weeks, patients from this RCT (NT-DFU-AFF-01) with study DFUs that have not been reduced in area by at least 40% will be exited from the study and considered treatment failures. This group (Group 2C) will constitute the active population in this single arm study (NT-DFU-AFF-02). Study wounds will receive up to 12 weeks of continuing SOC and fHSAM. The standard of care therapy in this study is offloading of the DFU, appropriate sharp or surgical debridement, and aggressive infection management with the use of appropriate dressings (defined later in the protocol). A number of offloading systems are commercially available. The choice of offloading will be at the discretion of the principal investigator but should be total contact casting, fixed ankle walker boot, or equivalent device to the fixed ankle walker boot. The Screening Phase (1 day) consists of a series of screening assessments designed to determine eligibility followed by, for those who meet the eligibility criteria (described in more detail below), treatment. At the Screening Visit (S1), written informed consent from the subject will be obtained by the Investigator or suitably qualified designee before the performance of any other protocol-specific procedure. The Screening Period is designed to determine whether subjects are eligible to proceed to the Treatment Phase of the study. The Treatment Phase (12 Weeks) begins on the same day as the screening visit. During the Treatment Phase, subjects will be evaluated on a weekly basis. Efficacy evaluations each week will include Investigator assessment of ulcer healing and measurements of ulcer size using digital photographic planimetry. Safety evaluations during the Treatment Phase will consist of adverse event assessments at each visit. Subjects whose ulcers do not achieve closure at 12 weeks or who experience an amputation will be deemed treatment failures.

Official Title
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A Multi-center, Randomized Controlled Clinical Trial Evaluating the Effect of Fresh Amniotic Membrane in the Treatment of Diabetic Foot Ulcers: Crossover Group From Standard of Care

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Other: Affinity human amniotic membrane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A percentage area reduction of less than 40% after having received 6 weeks of treatment with SOC in the NT-DFU-01 trial. Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen. Subject has read and signed the IRB/IEC approved Informed Consent Form. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence). At least 18 years old. Exclusion Criteria: Failure to complete 6 weeks of SOC in the original NT-DFU-01 study Any AE or SAE that occurred during the NT-DFU-01 study, which, in the opinion of the investigator would preclude the subject successfully having Affinity applied for up to 12 weeks. Subject is unlikely to complete a regimen of Affinity and SOC for up to 12 weeks due to personal reasons. Subject is pregnant or breast feeding. Osteomyelitis or bone infection of the affected foot as assessed by X-ray.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: Graft<br>Affinity human amniotic membrane | Other: Affinity human amniotic membrane<br>* fresh hypothermically stored human amniotic membrane<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to initial closure of diabetic foot ulcer |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of healed wounds |  | 12 weeks | 
| Mean wastage of graft | healed wounds only | 12 weeks | 
| Mean cost to heal | healed wounds only | 12 weeks |