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

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.