Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Chronic Pressure Ulcers

NCT07158658 | Recruiting

• 1 other identifier: NeoPress
• 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 Chronic Pressure Ulcers

Conditions

Pressure Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Complete Wound Closure

  Complete wound closure (100% epithelialization without drainage)

  1-16 weeks

Secondary Outcomes (3)

• Percent Area Reduction

  1-16 weeks

• Wound Closure

  2 weeks

• Number of Grafts

  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 (HCT/P 361)

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.

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 Pressure Injury/Ulcer located on the pelvis or lower extremity
• Subject has a Pressure Injury/Ulcer Stage 2 or 3 without infection
• Index ulcer is a minimum of 1cm2 and a maximum of 30cm2 at first treatment visit
• Index ulcer has a depth of ≤ 1cm2, and subject is compliant to use continuous NPWT with 75-100mmHg, at the providers discretion
• Index ulcer has a depth of \> 1cm2, and subject is compliant to use continuous NPWT with 75-100mmHg
• Pressure Injury/Ulcer is treated with offloading therapy while standing, sitting and lying down (if applicable to wound location) for 7 days prior to the first treatment visit
• Adequate circulation of ulcer, if located on the lower extremity, demonstrated by an ABI of \>0.7 and \<1.3, or TBI of \>0.6 within 30 days prior to the first treatment visit
• Index ulcer is free of infection prior to the first treatment visit and during screening phase.
• Index ulcer 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
• Subject is able and willing to follow the protocol requirements
• Subject had signed informed consent
• If 2 or more ulcers are present, the ulcers must be separated by at least 2 cm

You may not qualify if:

• Subject has a known life expectancy of \<1 year
• Subject is unable to comply with protocol treatment
• 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 in the opinion of the investigator
• 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 to tissue-engineered allograft
• Concurrent participation in alternative clinical trial that involves investigational drug or product 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 \>14 days 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 the first treatment visit
• Pressure Injury/Ulcer of Stage 4 or active osteomyelitis
• Wound depth with visible exposed bone
• HBOT within 14 days prior to the first treatment visit
• Revascularization surgery on the index ulcer leg within 30 days of screening phase
• Index ulcer suspicious of neoplasm in the opinion of the investigator

Sponsors & Collaborators

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

Study Sites (2)

MedCentris of Bossier City

Bossier City, Louisiana, 71111, United States

RECRUITING

MedCentris of Rayville

Rayville, Louisiana, 71269, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Angelina Ferguson, DNP

  SygNola, LLC

  STUDY CHAIR

Central Study Contacts

Angelina Ferguson, DNP

CONTACT

986-629-4013; dr.aferguson@sygnola.com

Sarah Moore, MBE

CONTACT

986-629-4013; sarah.moore@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: August 25, 2025
• First Posted: September 8, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)