Evaluating the Efficacy of NeoThelium FT in the Treatment of Venous Leg Ulcers

Sponsor
NuScience Medical Biologics, LLC
Study ID
NCT06930768
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard of Care — OTHER
    Wound cleansing, Sharps debridement, Dressing for moisture balance, Offloading
  • NeoThelium FT — OTHER
    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.

Study Details

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.

Key Dates

First listed
Apr 16, 2025
Start date
Jul 1, 2026
Status verified
Apr 2026
Primary completion
Mar 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: No Intervention: Standard of Care
    Wound cleansing, Sharps debridement, Dressing for moisture balance, Offloading
  • Experimental: Intervention: NeoThelium FT & Standard of Care
    Wound cleansing, sharps debridement, NeoThelium FT application, Dressing for moisture balance, Offloading

Primary Outcome Measure

Complete Wound Closure [ Time Frame: 1-12 weeks ]

Central Contacts

Related Studies