Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers

Part of paid clinical trials in Alexandria, Louisiana.

Sponsor
NuScience Medical Biologics, LLC
Study ID
NCT07039396
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 (HCT/P 361) 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 prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Diabetic Foot Ulcers

Key Dates

Start date
Aug 26, 2025
Status verified
Mar 2026
Primary completion
May 1, 2026
Completion
Jun 1, 2026

Study Design

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

Arms

  • Experimental: NeoThelium FT + 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 (3)

FacilityCityStateZIPSite coordinators
MedCentris of AlexandriaAlexandriaLouisiana71301
Laura Whittington, LPN
318-545-0655
Rachel Ward, FNP (PRINCIPAL_INVESTIGATOR)
MedCentris of LeesvilleLeesvilleLouisiana71446
Brandi Shuff, LPN
337-282-1091
Stefanie Corley, FNP (PRINCIPAL_INVESTIGATOR)
MedCentris of ManyManyLouisiana71449
Brandi Shuff, LPN
337-282-1091
Stefanie Corley, FNP (PRINCIPAL_INVESTIGATOR)

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