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

May 5, 2026 updated by: NuScience Medical Biologics, LLC

A Randomized Controlled Multisite Crossover Trial Evaluating the Efficacy of NeoThelium FT in the Treatment of "Other" Open Wounds

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This research will take place across multiple medical centers, where both researchers and participants will know which treatment is being used (open label). Patients who agree to participate and meet the study requirements during screening will be randomly assigned to one of two groups: either standard of care (SOC) alone, or SOC plus NeoThelium FT.

The study includes a crossover component for subjects in the SOC arm. At treatment visit 13 (approximately 84 days post-randomization), SOC arm subjects not having achieved complete wound closure, and still meeting the inclusion/exclusion criteria, are eligible to cross over to the IP arm (SOC plus NeoThelium FT). Crossover subjects will begin IP arm treatment with weekly NeoThelium FT applications for up to 12 treatment visits. The subject will continue follow-up per the original schedule. As this is a post-marketing study, it will gather information regarding the efficacy of treatment while also supporting insurance reimbursement decisions. All subjects will complete two-week screening phase prior to being randomized into a treatment arm. Treatment arms will consist of NeoThelium FT in conjunction with standard of care, vs. standard of care alone. The primary endpoint will be the percentage of target ulcers that achieve complete wound closure within 12 weeks. Secondary endpoints consist of wound percentage area reduction rates and pain assessment.

Study Type

Interventional

Enrollment (Estimated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Angelina Ferguson, DNP
  • Phone Number: (985) 629-4013
  • Email: info@sygnola.com

Study Contact Backup

Study Locations

  • United States
    • Louisiana
      • Denham Springs, Louisiana, United States, 70726
        • Recruiting
        • MedCentris of Denham Springs
        • Principal Investigator:
          • Monique Consoer, NP
        • Contact:
      • Hammond, Louisiana, United States, 70403
      • Lafayette, Louisiana, United States, 70507
      • Leesville, Louisiana, United States, 71146
        • Recruiting
        • MedCentris of Leesville
        • Principal Investigator:
          • Stefanie Corley, FNP
        • Contact:
      • Many, Louisiana, United States, 71449
      • Marksville, Louisiana, United States, 71351
      • Metairie, Louisiana, United States, 70001
        • Recruiting
        • MedCentris of Metairie
        • Contact:
        • Principal Investigator:
          • Sarah Logrande, NP
      • Minden, Louisiana, United States, 71055
      • Slidell, Louisiana, United States, 70458
        • Recruiting
        • MedCentris of Slidell
        • Principal Investigator:
          • Katie Schloegel, FNP
        • Contact:
    • Mississippi
      • D'Iberville, Mississippi, United States, 39540
        • Recruiting
        • MedCentris of D'iberville
        • Contact:
        • Principal Investigator:
          • Miranda Reeves, FNP
      • McComb, Mississippi, United States, 39648
      • Natchez, Mississippi, United States, 39120
        • Completed
        • MedCentris of Natchez
      • Southaven, Mississippi, United States, 38671
        • Recruiting
        • MedCentris of Southaven
        • Principal Investigator:
          • Carlene McAllister, NP
        • Contact:
    • New York
      • Brooklyn, New York, United States, 11234
        • Recruiting
        • Northeast Podiatry Consultant
        • Contact:
        • Principal Investigator:
          • David Simon, DPM, FACFAS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or Female, 18 years of age or older
  2. Subject has a medical diagnosis of "other" Open wound
  3. Subject has a chronic open wound present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC
  4. Subject has a chronic open wound with a historical wound measurement showing less than 25% healing within 14 days prior to screening
  5. Subject has a chronic open wound with screening wound measurement showing less than 25% healing within 14 days prior to randomization
  6. Subject has an Open wound without infection or clinically visible exposed bone
  7. Index wound is a minimum of 0.5cm2 and a maximum of 25cm2 at first treatment visit
  8. Index ulcer has a maximum depth of 1cm at screening visit 1
  9. The chronic open wound is treated with offloading therapy, if applicable to location, while standing, sitting, and lying down for 14 days prior to randomization
  10. Adequate circulation of wounds located below the knee demonstrated by an ABI of >0.7 and <1.3, or TBI of >0.6 within 30 days prior to randomization OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to randomization.
  11. Index ulcer is free of infection prior to randomization and during screening phase.
  12. Index ulcer is free of necrotic debris prior to NeoThelium FT application
  13. Female subjects of childbearing potential having a negative pregnancy test prior to randomization
  14. 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.
  15. Subject is able and willing to follow the protocol requirements
  16. Subject had signed informed consent
  17. If 2 or more ulcers are present, the ulcers must be separated by at least 2 cm

Exclusion Criteria:

  1. Subject with a wound diagnosis of diabetic foot wound, pressure wound, venous leg wound, burn wound, or alternative diagnosis other than "open wound"
  2. Subject has a known life expectancy of <1 year
  3. Subject is unable to comply with protocol treatment
  4. 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.
  5. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound
  6. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
  7. Known contraindications to tissue-engineered allograft
  8. Concurrent participation in alternative clinical trial that involves investigational drug or product interfering with wound treatment and/or healing
  9. Subject is pregnant or breastfeeding
  10. Subject with history of immunosuppressant treatment (systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the wound surface for >2 weeks duration within 30 days prior to randomization; or anticipated use of the above during the course of the study
  11. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization
  12. Open wound with active infection
  13. Wound depth with visible exposed bone
  14. HBOT within 14 days prior to randomization
  15. Revascularization surgery on the index wound leg within 30 days of screening phase
  16. Index wound suspicious of neoplasm in the opinion of the principal investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: No Intervention: Standard of Care
Wound cleansing, Sharps debridement, Dressing for moisture balance, Offloading
Other: 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
Other: NeoThelium FT
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Wound Closure
Time Frame: 1-12 weeks
The primary endpoint will be the percentage of target ulcers that achieve complete wound closure.
1-12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Wound Area Change
Time Frame: 1-12 weeks
The percentage change in wound area from TV-1 to TV-13 will be measured weekly using digital photographic planimetry and physical examination.
1-12 weeks
Pain Assessment
Time Frame: Day 0, Day 14, Day 35, Day 56, Day 84
Change in pain associated with the target ulcer will be assessed using the Numeric Pain Rating Scale at designated time points
Day 0, Day 14, Day 35, Day 56, Day 84

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Closure
Time Frame: 1-12 weeks
Average number of grafts and/or weeks used to achieve wound closure
1-12 weeks
Follow-Up Closure
Time Frame: 2 weeks
Number of wounds remaining closed during the 2-week follow-up
2 weeks
Adverse Events and Serious Adverse Events
Time Frame: Day -14 through 91 days
The number and nature of adverse events (AEs) and series adverse events (SAEs) occurring during the study will be tracked and reported.
Day -14 through 91 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NuScience Medical Biologics, LLC

Collaborators

SygNola, LLC

Investigators

  • Study Director: Angelina Ferguson, DNP, SygNola, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

March 31, 2025

First Submitted That Met QC Criteria

April 8, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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