Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers

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

Evaluation of the Efficacy of NeoThelium FT in the Healing of Chronic Diabetic Foot Ulcers: A Randomized Controlled Multicenter Crossover Trial

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 diabetic foot ulcers.

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 a 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 area reduction rates, time to closure, follow-up closure, 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
      • Alexandria, Louisiana, United States, 71301
      • Franklinton, Louisiana, United States, 70438
      • Hammond, Louisiana, United States, 70403
      • Minden, Louisiana, United States, 71055
      • Monroe, Louisiana, United States, 71201
    • Mississippi
      • Natchez, Mississippi, United States, 39120
        • Completed
        • MedCentris of Natchez
      • Picayune, Mississippi, United States, 39466
        • Recruiting
        • MedCentris of Picayune
        • Contact:
        • Principal Investigator:
          • Gavin Mayo, FNP
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Completed
        • Pace Foot and Ankle Center

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 Type I or Type II Diabetes Mellitus requiring oral or glycemic control and/or insulin replacement therapy
  3. Subject has a diabetic foot ulcer 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 diabetic foot ulcer with a historical wound measurement showing less than 25% healing in 14 days prior to screening
  5. Subject has a diabetic foot ulcer with screening wound measurement showing less than 25% healing in 14 days prior to randomization
  6. Subject has a diabetic foot ulcer of Wagner grade 1, 2, or 3 without infection or clinically visible exposed bone. Wagner 3 is acceptable if the diagnosis is acute osteomyelitis and the subject has successfully completed IV antibiotic treatment prior to screening.
  7. Index ulcer is a minimum of 0.5cm2 and a maximum of 25cm2 at first treatment visit
  8. Diabetic foot ulcer is being treated with offloading therapy for 14 days prior to randomization
  9. 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 OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to randomization.
  10. Index ulcer is free of infection prior to randomization and during screening phase. Infection must be adequately treated and controlled as defined by Infectious Disease Society of America (IDSA) Guidelines PEDIS Grade 1.
  11. Index ulcer is free of necrotic debris prior to NeoThelium FT application
  12. Female subjects of childbearing potential having a negative pregnancy test prior to randomization
  13. Subject is able and willing to follow the protocol requirements
  14. Subject had signed informed consent
  15. If 2 or more ulcers are present, the ulcers must be separated by at least 2 cm

Exclusion Criteria:

  1. Subject has a known life expectance of <1 year
  2. Subject is unable to comply with protocol treatment
  3. 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
  4. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound
  5. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
  6. Known contraindications to tissue-engineered allograft
  7. Concurrent participation in alternative clinical trial that involves investigational drug or device interfering with wound treatment and/or healing
  8. Subject is pregnant or breastfeeding
  9. 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
  10. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization
  11. Diabetic foot ulcer of Wagner 3 grade with active acute infection that has not completed IV antibiotic treatment, or Wagner 3 grade with chronic refractory osteomyelitis
  12. Wound depth with visible exposed bone
  13. HBOT within 14 days prior to randomization
  14. Revascularization surgery on the index ulcer leg within 30 days of screening phase
  15. Index ulcer 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
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
Hemoglobin A1c
Time Frame: Day -14 through 91 days
Incidence of wound closure vs HbA1c
Day -14 through 91 days
Time to Closure
Time Frame: 1-12 weeks
Average number of grafts/weeks used to achieve wound closure
1-12 weeks

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 Chair: Desmond Bell, DPM, 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 6, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

March 31, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 22, 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

  • OMNEO

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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