Evaluating the Efficacy of NeoThelium FT in the Treatment of Pressure Injuries

NCT06918548 | Not Yet Recruiting

• 1 other identifier: PROTECT
• Study Type: interventional
• Target: 148
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized controlled trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating pressure injuries.

Conditions

Pressure Injury

Keywords

Chronic wounds; Wound Medicine; 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.

  1-16 weeks

Secondary Outcomes (4)

• Percentage Wound Area Change

  1-16 weeks

• Time to Closure

  1-16 weeks

• Follow-Up Closure

  2 weeks

• Pain Assessment

  Day 0, Day 14, Day 35, Day 56, Day 77, Day 98, Day 112

Other Outcomes (2)

• Wound closure rate in comparison to initial area

  Day 0 through Day 112

• Adverse Events and Serious Adverse Events

  Day -14 through 126 days

Study Arms (2)

No Intervention: Standard of Care

ACTIVE COMPARATOR

Wound cleansing, Sharps debridement, Dressing for moisture balance, Offloading

Other: Standard of Care

Intervention: NeoThelium FT & Standard of Care

EXPERIMENTAL

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

Other: NeoThelium FT

Interventions

Standard of Care OTHER

Wound cleansing, Sharps debridement, Dressing for moisture balance, Offloading

No Intervention: Standard of Care

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.

Intervention: NeoThelium FT & Standard of Care

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 present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC
• Subject has a Pressure Injury/Ulcer with a historical wound measurement showing less than 50% healing within 30 days prior to randomization
• Subject has a Pressure Injury/Ulcer with screening wound measurement showing less than 25% healing within 14 days prior to randomization
• Subject has a Pressure Injury/Ulcer Stage 2, 3, and 4 without infection or clinically visible exposed bone
• Index ulcer is a minimum of 1cm2 and a maximum of 25cm2 at first treatment visit
• Index ulcer has a maximum depth of 1cm at first screening visit
• Pressure Injury/Ulcer is treated with offloading therapy while standing, sitting and lying down (if applicable to wound location) for 14 days prior to randomization
• Adequate circulation of ulcer demonstrated by an ABI of \>0.7 and \<1.3, or TBI of \>0.6 within 30 days prior to randomization
• Index ulcer is free of infection prior to randomization and during screening phase.
• Index ulcer is free of necrotic debris prior to \[insert product/device\] application
• Female subjects of childbearing potential having a negative pregnancy test prior to randomization
• Index ulcer is free of infection prior to randomization and during screening phase noted with the NERDS Assessment. Infection must be adequately treated and controlled prior to randomization.
• Having a Mini Nutritional Assessment Score of 12 or higher indicated a normal nutritional status

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
• 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
• Wound reduces in area by ≥25% after 14 days of SOC prior to randomization
• 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 randomization; 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 randomization
• Pressure Injury/Ulcer of Stage 4 grade with active osteomyelitis or exposed visible bone
• Wound depth with visible exposed bone
• HBOT within 14 days prior to randomization
• Revascularization surgery on the index ulcer leg within 30 days of screening phase

Sponsors & Collaborators

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

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Angelina Ferguson, DNP

  SygNola, LLC

  STUDY DIRECTOR

Central Study Contacts

Angelina Ferguson, DNP

CONTACT

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

Sarah Moore, MBE

CONTACT

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

Study Design

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

Model Details: The subject will be randomized to one of the following treatments: * Standard of care * NeoThelium FT in addition to standard of care

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 9, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share