Evaluating the Efficacy and Safety of NeoThelium FT Amnion Skin Graft in the Management of Venous Leg Ulcers: A Prospective Case Series

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Venous Leg Ulcers

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or Female, 18 years of age or older

• Subject has a medical diagnosis of venous leg ulcer or venous insufficiency with a lower extremity wound

• Subject has an venous leg ulcer without infection or clinically visible exposed bone

• Index wound is a minimum of 1 cm2 and a maximum of 30 cm2 at first treatment visit

• Adequate circulation if wound is location on the lower extremity demonstrated by an ABI of \>0.7 and \<1.3, or TBI of \>0.6 within 30 days prior to informed consent OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to the first treatment visit.

• Venous Leg Ulcer is being treated with compression therapy for 7 days prior to treatment visit 1

• Index wound is free of necrotic debris prior to NeoThelium FT application

• Female subjects of childbearing potential having a negative pregnancy test prior to the first treatment visit

• Wound free of clinical signs/symptoms of infection (no purulent discharge or cellulitis) post-debridement during screening and prior to the first treatment visit.

⁃ Subject is able and willing to follow the protocol requirements

⁃ Subject had signed informed consent

⁃ If 2 or more wounds are present, the wounds must be separated by at least 2 cm

Locations
United States
Louisiana
MedCentris of Slidell
RECRUITING
Slidell
Contact Information
Primary
Angelina Ferguson, DNP
info@sygnola.com
(985) 629-4013
Backup
Sarah Moore
info@sygnola.com
(985) 629-4013
Time Frame
Start Date: 2025-09-02
Estimated Completion Date: 2026-03-29
Participants
Target number of participants: 10
Treatments
Experimental: NeoThelium FT (HCT/P 361)+ SOC
Wound cleansing, sharps debridement, NeoThelium FT application, Dressing for moisture balance, Offloading
Related Therapeutic Areas
Sponsors
Leads: NuScience Medical Biologics, LLC
Collaborators: SygNola, LLC

This content was sourced from clinicaltrials.gov