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

NCT07061613 | Recruiting

• 1 other identifier: NeoVein
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Venous Leg Ulcer

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.

  1-12 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 (HCT/P 361)+ SOC

EXPERIMENTAL

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

Other: NeoThelium FT (HCT/P 361)

Interventions

NeoThelium FT (HCT/P 361) OTHER

NeoThelium FT is a dehydrated wound covering derived from donated human placental tissue.

NeoThelium FT (HCT/P 361)+ 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 venous leg ulcer or venous insufficiency with a lower extremity wound
• Subject has an venous leg ulcer without infection or clinically visible exposed bone
• Index wound is a minimum of 1 cm2 and a maximum of 30 cm2 at first treatment visit
• 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.
• Venous Leg Ulcer is being treated with compression therapy for 7 days prior to treatment visit 1
• Index wound is free of necrotic debris prior to NeoThelium FT application
• Female subjects of childbearing potential having a negative pregnancy test prior to the first treatment visit
• Wound free of clinical signs/symptoms of infection (no purulent discharge or cellulitis) post-debridement during screening and prior to the first treatment visit.
• Subject is able and willing to follow the protocol requirements
• Subject had signed informed consent
• If 2 or more wounds are present, the wounds must be separated by at least 2 cm

You may not qualify if:

• Subject is unable to comply with protocol treatment
• Presence of infection prior to screening.
• Multiple VLUs on the same leg with \< 2 cm separation from the target ulcer.
• Subject has comorbid conditions that may compromise subject safety or wound healing in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders
• 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

Sponsors & Collaborators

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

Study Sites (2)

MedCentris of Metairie

Metairie, Louisiana, 70001, United States

COMPLETED

MedCentris of Slidell

Slidell, Louisiana, 70458, United States

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Angelina Ferguson

  SygNola, LLC

  STUDY CHAIR

Central Study Contacts

Angelina Ferguson, DNP

CONTACT

(985) 629-4013; info@sygnola.com

Sarah Moore

CONTACT

(985) 629-4013; info@sygnola.com

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: July 1, 2025
• First Posted: July 11, 2025
• Study Start: September 2, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 29, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)