Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Open Wounds

NCT07041177 | Completed

• 1 other identifier: NeOpen
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Open Wounds

Conditions

Open Wound

Keywords

Chronic Wounds; Cellular, Acellular, Matrix-like Product (CAMP); Cellular and/or Tissue Product (CTP); Dehydrated Complete Human Placental Membrane (dCHPM)

Outcome Measures

Primary Outcomes (1)

• Complete Wound Closure

  The primary endpoint will be the percentage of target ulcers that achieve complete wound closure.

  1-14 weeks

Secondary Outcomes (3)

• Percentage Wound Area Change

  1-12 weeks

• Follow-Up Closure

  2 weeks

• Time to Closure

  1-12 weeks

Study Arms (1)

NeoThelium FT + SOC

EXPERIMENTAL

Wound cleansing, sharps debridement, NeoThelium FT application, Dressing for moisture balance, Offloading

Other: NeoThelium FT

Interventions

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.

NeoThelium FT + SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female, 18 years of age or older
• Subject has a medical diagnosis of "other" Open wound
• Subject has a chronic open wound present for 4 weeks or greater (documented in medical record)
• Ulcer area is a minimum of 1 cm2 and a maximum of 25 cm2 at first treatment visit
• Index wound has a maximum depth of 1cm at the first treatment visit
• Subject is able and willing to follow the protocol requirements
• Subject had signed informed consent
• Adequate circulation if wound is location on the lower extremity demonstrated by an ABI of \>0.7 and \<1.3, or TBI of \>0.6 within 30 days prior to informed consent OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to the first treatment visit.
• The chronic open wound is treated with offloading therapy at the Principal Investigator's discretion, if applicable to location, while standing, sitting, and lying down for 7 days prior to the first treatment visit
• Wound free of clinical infection or clinically visible exposed bone (no purulent discharge, cellulitis, or osteomyelitis) 7 days prior to treatment visit 1

You may not qualify if:

• Subject is unable to comply with protocol treatment
• Subject with a wound diagnosis of diabetic foot wound, pressure wound, venous leg wound, burn wound, or alternative diagnosis other than "open wound"
• Presence of systemic infection, sepsis, or osteomyelitis at screening.
• Multiple wounds at the same site of the referenced wound with \< 2 cm separation from the target ulcer.
• Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing.
• Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound.
• Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
• Known contraindications or hypersensitivity to amniotic membrane products or components of NeoThelium FT.
• Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P interfering with wound treatment and/or healing.
• Subject is pregnant or breastfeeding
• Subject with history of immunosuppressant treatment (systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the ulcer surface for \>2 weeks duration within 30 days prior to the first treatment visit; or anticipated use of the above during the course of the study
• Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to enrollment
• Index ulcer suspicious of neoplasm in the opinion of the principal investigator
• Open wound with active infection
• Wound depth with visible exposed bone

Sponsors & Collaborators

• NuScience Medical Biologics, LLC: lead
• SygNola, LLC: collaborator

Study Sites (1)

MedCentris of Hammond

Hammond, Louisiana, 70403, United States

Location

Study Officials

• Angelina Ferguson, DNP

  SygNola, LLC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: NeoThelium FT in addition to Standard of Care

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 27, 2025
• Study Start: August 25, 2025
• Primary Completion: April 10, 2026
• Study Completion: April 10, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)