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

NuScience Medical Biologics, LLC

Status: Enrolling

Conditions: Venous Leg Ulcer

Treatments: Other: NeoThelium FT (HCT/P 361)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07061613

NeoVein

Details and patient eligibility

About

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

Full 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 begin SOC plus NeoThelium FT weekly applications. 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

NeoThelium FT (HCT/P 361)+ SOC

Experimental group

Description:

Wound cleansing, sharps debridement, NeoThelium FT application, Dressing for moisture balance, Offloading

Treatment:

Other: NeoThelium FT (HCT/P 361)