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.
Single group
NeoThelium FT (HCT/P 361)
Other interventionNeoThelium FT (HCT/P 361) is a dehydrated wound covering derived from donated human placental tissue. NeoThelium FT is a dual-layer membrane with amnion and chorion combination layers.
Complete wound closure
The primary endpoint will be the percentage of target ulcers that achieve complete wound closure by manual measurement utilizing a ruler.
Percentage Wound Area Change
The percentage change in wound area from TV-1 to TV-13 will be measured weekly using standardized method of wound area measurement and physical examination.
Follow-Up Closure
Number of wounds remaining closed during the 2-week follow-up
Time to Closure
Average number of grafts/weeks used to achieve wound closure
Hemoglobin A1c
Average Sample of HbA1c
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NuScience Medical Biologics, LLC
Lead sponsor
SygNola, LLC
Collaborator
