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

NCT06938685 | Recruiting

• 1 other identifier: OMNEO
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Diabetic Foot Ulcer

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.

  1-12 weeks

Secondary Outcomes (2)

• Percentage Wound Area Change

  1-12 weeks

• Pain Assessment

  Day 0, Day 14, Day 35, Day 56, Day 84

Other Outcomes (4)

• Hemoglobin A1c

  Day -14 through 91 days

• Adverse Events and Serious Adverse Events

  Day -14 through 91 days

• Time to Closure

  1-12 weeks

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 Type I or Type II Diabetes Mellitus requiring oral or glycemic control and/or insulin replacement therapy
• 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
• Subject has a diabetic foot ulcer with a historical wound measurement showing less than 25% healing in 14 days prior to screening
• Subject has a diabetic foot ulcer with screening wound measurement showing less than 25% healing in 14 days prior to randomization
• 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.
• Index ulcer is a minimum of 0.5cm2 and a maximum of 25cm2 at first treatment visit
• Diabetic foot ulcer is being treated with offloading therapy 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 OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to randomization.
• 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.
• Index ulcer is free of necrotic debris prior to NeoThelium FT application
• Female subjects of childbearing potential having a negative pregnancy test prior to randomization
• 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 expectance 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 device 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 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
• 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
• 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
• Index ulcer suspicious of neoplasm in the opinion of the principal investigator

Sponsors & Collaborators

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

Study Sites (8)

MedCentris of Alexandria

Alexandria, Louisiana, 71301, United States

RECRUITING

MedCentris of Franklinton

Franklinton, Louisiana, 70438, United States

RECRUITING

MedCentris of Hammond

Hammond, Louisiana, 70403, United States

RECRUITING

MedCentris of Minden

Minden, Louisiana, 71055, United States

RECRUITING

MedCentris of Monroe

Monroe, Louisiana, 71201, United States

RECRUITING

MedCentris of Natchez

Natchez, Mississippi, 39120, United States

COMPLETED

MedCentris of Picayune

Picayune, Mississippi, 39466, United States

RECRUITING

Pace Foot and Ankle Center

Bryn Mawr, Pennsylvania, 19010, United States

COMPLETED

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

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

Study Officials

• Desmond Bell, DPM

  SygNola, LLC

  STUDY CHAIR

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: CROSSOVER
• 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 22, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)