Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Venous Leg Ulcers

Part of paid clinical trials in Metairie, Louisiana.

Sponsor
NuScience Medical Biologics, LLC
Study ID
NCT07061613
Status
Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • NeoThelium FT (HCT/P 361) — OTHER
    NeoThelium FT is a dehydrated wound covering derived from donated human placental tissue.

Study Details

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

Key Dates

Start date
Sep 2, 2025
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Jul 29, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NeoThelium FT (HCT/P 361)+ SOC
    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

Locations (2)

FacilityCityStateZIPSite coordinators
MedCentris of MetairieMetairieLouisiana70001-
MedCentris of SlidellSlidellLouisiana70458
Donyille Singletary, RN
Katie Schloegel, FNP (PRINCIPAL_INVESTIGATOR)

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