Evaluating the Efficacy of NeoThelium FT in the Treatment of Chronic Open Wounds

Conditions

• Open Wound

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 chronic open wounds.

Key Dates

Start date

Oct 16, 2025

Status verified

May 2026

Primary completion

Aug 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

• Angelina Ferguson, DNP
  (985) 629-4013
  [email protected]
• Sarah Moore, MBE
  (985) 629-4013
  [email protected]

Locations (14)

Find similar trials in Denham Springs, LA

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