RECRUITING

Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Venous Leg Ulcers

Conditions

Venous Leg 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 Venous Leg Ulcers

Official Title

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

Quick Facts

Study Start:2025-09-02

Study Completion:2026-03-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07061613

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 venous leg ulcer or venous insufficiency with a lower extremity wound 3. Subject has an venous leg ulcer without infection or clinically visible exposed bone 4. Index wound is a minimum of 1 cm2 and a maximum of 30 cm2 at first treatment visit 5. 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. 6. Venous Leg Ulcer is being treated with compression therapy for 7 days prior to treatment visit 1 7. Index wound is free of necrotic debris prior to NeoThelium FT application 8. Female subjects of childbearing potential having a negative pregnancy test prior to the first treatment visit 9. Wound free of clinical signs/symptoms of infection (no purulent discharge or cellulitis) post-debridement during screening and prior to the first treatment visit. 10. Subject is able and willing to follow the protocol requirements 11. Subject had signed informed consent 12. If 2 or more wounds are present, the wounds must be separated by at least 2 cm	1. Subject is unable to comply with protocol treatment 2. Presence of infection prior to screening. 3. Multiple VLUs on the same leg with \< 2 cm separation from the target ulcer. 4. Subject has comorbid conditions that may compromise subject safety or wound healing in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders 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 or hypersensitivity to amniotic membrane products or components of NeoThelium FT. 8. Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P 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 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 11. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to enrollment 12. 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 venous leg ulcer or venous insufficiency with a lower extremity wound
3. Subject has an venous leg ulcer without infection or clinically visible exposed bone
4. Index wound is a minimum of 1 cm2 and a maximum of 30 cm2 at first treatment visit
5. 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.
6. Venous Leg Ulcer is being treated with compression therapy for 7 days prior to treatment visit 1
7. Index wound is free of necrotic debris prior to NeoThelium FT application
8. Female subjects of childbearing potential having a negative pregnancy test prior to the first treatment visit
9. Wound free of clinical signs/symptoms of infection (no purulent discharge or cellulitis) post-debridement during screening and prior to the first treatment visit.
10. Subject is able and willing to follow the protocol requirements
11. Subject had signed informed consent
12. If 2 or more wounds are present, the wounds must be separated by at least 2 cm

1. Subject is unable to comply with protocol treatment
2. Presence of infection prior to screening.
3. Multiple VLUs on the same leg with \< 2 cm separation from the target ulcer.
4. Subject has comorbid conditions that may compromise subject safety or wound healing in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders
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 or hypersensitivity to amniotic membrane products or components of NeoThelium FT.
8. Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P 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 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
11. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to enrollment
12. Index ulcer suspicious of neoplasm in the opinion of the principal investigator

Contacts and Locations

Study Contact

Angelina Ferguson, DNP

CONTACT

(985) 629-4013

info@sygnola.com

Sarah Moore

CONTACT

(985) 629-4013

info@sygnola.com

Principal Investigator

Angelina Ferguson

STUDY_CHAIR

SygNola, LLC

Study Locations (Sites)

MedCentris of Slidell

Slidell, Louisiana, 70458

United States

Collaborators and Investigators

Sponsor: NuScience Medical Biologics, LLC

Angelina Ferguson, 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 Date2025-09-02

Study Completion Date2026-03-29

Study Record Updates

Study Start Date2025-09-02

Study Completion Date2026-03-29

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

Venous Leg Ulcer