Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers

Part of paid clinical trials in Alexandria, Louisiana.

Sponsor
NuScience Medical Biologics, LLC
Study ID
NCT06938685
Status
Recruiting
Apply to this trial

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 crossover trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating diabetic foot ulcers.

Key Dates

Start date
Oct 6, 2025
Status verified
May 2026
Primary completion
Sep 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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

Locations (8)

FacilityCityStateZIPSite coordinators
MedCentris of AlexandriaAlexandriaLouisiana71301
Laura Whittington, LPN
[email protected]
Rachel Ward, FNP (PRINCIPAL_INVESTIGATOR)
MedCentris of FranklintonFranklintonLouisiana70438
Amanda Stephens
[email protected]
Tony Seal, NP (PRINCIPAL_INVESTIGATOR)
MedCentris of HammondHammondLouisiana70403
Chelsea Smith
[email protected]
Amber Landry, NP (PRINCIPAL_INVESTIGATOR)
MedCentris of MindenMindenLouisiana71055
Brianna Thompson
[email protected]
Taheera Forbes, NP (PRINCIPAL_INVESTIGATOR)
MedCentris of MonroeMonroeLouisiana71201
Monica Shinall, BSN
[email protected]
Tiffany Dew, LPN
[email protected]
Libbi Trawick, NP (PRINCIPAL_INVESTIGATOR)
MedCentris of NatchezNatchezMississippi39120-
MedCentris of PicayunePicayuneMississippi39466
Emily Adams, LPN
[email protected]
Gavin Mayo, FNP (PRINCIPAL_INVESTIGATOR)
Pace Foot and Ankle CenterBryn MawrPennsylvania19010-

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