This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Diabetic Foot Ulcers
Male or Female, 18 years of age or older
Subject has a medical diagnosis of Type I or Type II Diabetes Mellitus requiring oral or glycemic control and/or insulin replacement therapy with a diabetic foot ulcer
Subject has a diabetic foot ulcer of Wagner grade 1, 2, or 3 without infection or clinically visible exposed bone. Wagner 3 is acceptable if the diagnosis is acute osteomyelitis and the subject has successfully completed IV antibiotic treatment prior to screening.
Ulcer area is a minimum of 0.5 cm2 and a maximum of 25 cm2 at first treatment visit
Subject is unable to comply with protocol treatment
Target ulcer is a Wagner 3 of acute osteomyelitis that has not been successfully treated with 6 weeks of IV antibiotics or is diagnosed as chronic refractory osteomyelitis.
Wagner 3, 4, or 5 involving tendon, bone, or joint.
Presence of systemic infection, sepsis, or osteomyelitis at screening.
NuScience Medical Biologics, LLC
Lead sponsor
SygNola, LLC
Collaborator