This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Open Wounds
This research will take place across multiple medical centers, where both researchers and participants will know which treatment is being used (open label). Patients who agree to participate and meet the study requirements during screening will begin SOC plus NeoThelium FT weekly applications. The subject will continue follow-up per the original schedule. As this is a post-marketing study, it will gather information regarding the efficacy of treatment while also supporting insurance reimbursement decisions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
NeoThelium FT is a dehydrated wound covering derived from donated human placental tissue. NeoThelium FT is a dual-layer membrane with amnion and chorion combination layers.
MedCentris of Hammond
Hammond, Louisiana, United States
RECRUITINGComplete Wound Closure
The primary endpoint will be the percentage of target ulcers that achieve complete wound closure.
Time frame: 1-14 weeks
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.
Time frame: 1-12 weeks
Follow-Up Closure
Number of wounds remaining closed during the 2-week follow-up
Time frame: 2 weeks
Time to Closure
Average number of grafts/weeks used to achieve wound closure
Time frame: 1-12 weeks
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