RECRUITING

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

Conditions

Diabetic Foot Ulcer Chronic Wounds Cellular, Acellular, Matrix-like product (CAMP)Cellular and/or Tissue Product (CTP)Dehydrated Complete Human Placental Membrane (dCHPM)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Evaluating the Efficacy and Safety of NeoThelium FT Amnion Skin Graft in the Management of Diabetic Foot Ulcers: A Prospective Case Series

Quick Facts

Study Start:2025-08-26

Study Completion:2026-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07039396

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 with a diabetic foot ulcer 3. 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. 4. Ulcer area is a minimum of 0.5 cm2 and a maximum of 25 cm2 at first treatment visit 5. Subject is able and willing to follow the protocol requirements 6. Subject had signed informed consent 7. 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. 8. 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 9. Wound free of clinical infection (no purulent discharge, cellulitis, or osteomyelitis) post-debridement. 10. Record of serum hemoglobin A1c within 90 days prior to the first treatment visit	1. Subject is unable to comply with protocol treatment 2. 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. 3. Wagner 3, 4, or 5 involving tendon, bone, or joint. 4. Presence of systemic infection, sepsis, or osteomyelitis at screening. 5. Multiple DFUs on the same foot with \< 2 cm separation from the target ulcer. 6. 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. 7. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound. 8. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator 9. Known contraindications or hypersensitivity to amniotic membrane products or components of NeoThelium FT. 10. Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P interfering with wound treatment and/or healing. 11. Subject is pregnant or breastfeeding 12. 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 13. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to enrollment 14. Index ulcer suspicious of neoplasm in the opinion of the principal investigator

Inclusion Criteria

Exclusion 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 with a diabetic foot ulcer
3. 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.
4. Ulcer area is a minimum of 0.5 cm2 and a maximum of 25 cm2 at first treatment visit
5. Subject is able and willing to follow the protocol requirements
6. Subject had signed informed consent
7. 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.
8. 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
9. Wound free of clinical infection (no purulent discharge, cellulitis, or osteomyelitis) post-debridement.
10. Record of serum hemoglobin A1c within 90 days prior to the first treatment visit

1. Subject is unable to comply with protocol treatment
2. 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.
3. Wagner 3, 4, or 5 involving tendon, bone, or joint.
4. Presence of systemic infection, sepsis, or osteomyelitis at screening.
5. Multiple DFUs on the same foot with \< 2 cm separation from the target ulcer.
6. 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.
7. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound.
8. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
9. Known contraindications or hypersensitivity to amniotic membrane products or components of NeoThelium FT.
10. Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P interfering with wound treatment and/or healing.
11. Subject is pregnant or breastfeeding
12. 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
13. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to enrollment
14. Index ulcer suspicious of neoplasm in the opinion of the principal investigator

Contacts and Locations

Study Contact

Angelina Ferguson, DNP

CONTACT

986-629-4013

info@sygnola.com

Sarah Moore, MBE

CONTACT

986-629-4013

info@sygnola.com

Principal Investigator

Angelina Ferguson, DNP

STUDY_CHAIR

SygNola, LLC

Study Locations (Sites)

MedCentris of Alexandria

Alexandria, Louisiana, 71301

United States

Collaborators and Investigators

Sponsor: NuScience Medical Biologics, LLC

Angelina Ferguson, DNP, STUDY_CHAIR, 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 Registration Dates

Study Start Date2025-08-26

Study Completion Date2026-01-01

Study Record Updates

Study Start Date2025-08-26

Study Completion Date2026-01-01

Terms related to this study

Keywords Provided by Researchers

Chronic Wounds
Cellular, Acellular, Matrix-like product (CAMP)
Cellular and/or Tissue Product (CTP)
Dehydrated Complete Human Placental Membrane (dCHPM)

Additional Relevant MeSH Terms

Diabetic Foot Ulcer