Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers

NCT07039396 | Recruiting

• 1 other identifier: NeoDia
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief Summary

This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Diabetic Foot Ulcers

Conditions

Diabetic Foot Ulcer

Keywords

Chronic Wounds; 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 by manual measurement utilizing a ruler.

  1-12 weeks

Secondary Outcomes (4)

• Percentage Wound Area Change

  1-12 weeks

• Follow-Up Closure

  2 weeks

• Time to Closure

  1-12 weeks

• Hemoglobin A1c

  1 week

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 Type I or Type II Diabetes Mellitus requiring oral or glycemic control and/or insulin replacement therapy with a diabetic foot ulcer
• 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.
• Ulcer area is a minimum of 0.5 cm2 and a maximum of 25 cm2 at first treatment visit
• Subject is able and willing to follow the protocol requirements
• Subject had signed informed consent
• Adequate circulation if wound is location on the lower extremity demonstrated by an ABI of \>0.7 and \<1.3, or TBI of \>0.6 within 30 days prior to informed consent OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to the first treatment visit.
• Diabetic foot ulcer is being treated with TCC offloading therapy OR Fixed Ankle Walker if approved by Medical Monitor for 7 days prior to treatment visit 1
• Wound free of clinical infection (no purulent discharge, cellulitis, or osteomyelitis) post-debridement.
• Record of serum hemoglobin A1c within 90 days prior to the first treatment visit

You may not qualify if:

• Subject is unable to comply with protocol treatment
• Target ulcer is a Wagner 3 of acute osteomyelitis that has not been successfully treated with 6 weeks of IV antibiotics or is diagnosed as chronic refractory osteomyelitis.
• Wagner 3, 4, or 5 involving tendon, bone, or joint.
• Presence of systemic infection, sepsis, or osteomyelitis at screening.
• Multiple DFUs on the same foot with \< 2 cm separation from the target ulcer.
• 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 or hypersensitivity to amniotic membrane products or components of NeoThelium FT.
• Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P 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 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 enrollment
• Index ulcer suspicious of neoplasm in the opinion of the principal investigator

Sponsors & Collaborators

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

Study Sites (3)

MedCentris of Alexandria

Alexandria, Louisiana, 71301, United States

RECRUITING

MedCentris of Leesville

Leesville, Louisiana, 71446, United States

RECRUITING

MedCentris of Many

Many, Louisiana, 71449, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

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

Study Officials

• Angelina Ferguson, DNP

  SygNola, LLC

  STUDY CHAIR

Central Study Contacts

Angelina Ferguson, DNP

CONTACT

986-629-4013; info@sygnola.com

Sarah Moore, MBE

CONTACT

986-629-4013; info@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: June 18, 2025
• First Posted: June 26, 2025
• Study Start: August 26, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)