Evaluating the Efficacy of NeoThelium FT in the Treatment of Venous Leg Ulcers
NCT06930768 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132
Last updated 2026-04-13
Summary
This is a randomized controlled trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating venous leg ulcers.
Conditions
- Venous Leg Ulcer
Interventions
- OTHER
-
Standard of Care
Wound cleansing, Sharps debridement, Dressing for moisture balance, Offloading
- OTHER
-
NeoThelium FT
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.
Sponsors & Collaborators
-
SygNola, LLC
collaborator INDUSTRY -
NuScience Medical Biologics, LLC
lead INDUSTRY
Principal Investigators
-
Angelina Ferguson, DNP · SygNola, LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-01
- Primary Completion
- 2027-03-01
- Completion
- 2027-06-01
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