Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Open Wounds

NuScience Medical Biologics, LLC

Status: Enrolling

Conditions: Open Wound

Treatments: Other: NeoThelium FT

Study type: Interventional

Funder types: Industry

Identifiers

NCT07041177

NeOpen

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 Open Wounds

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 "other" Open wound
3. Subject has a chronic open wound present for 4 weeks or greater (documented in medical record)
4. Ulcer area is a minimum of 1 cm2 and a maximum of 25 cm2 at first treatment visit
5. Index wound has a maximum depth of 1cm at the first treatment visit
6. Subject is able and willing to follow the protocol requirements
7. Subject had signed informed consent
8. 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.
9. The chronic open wound is treated with offloading therapy at the Principal Investigator's discretion, if applicable to location, while standing, sitting, and lying down for 7 days prior to the first treatment visit
10. Wound free of clinical infection or clinically visible exposed bone (no purulent discharge, cellulitis, or osteomyelitis) 7 days prior to treatment visit 1

Exclusion criteria

1. Subject is unable to comply with protocol treatment
2. Subject with a wound diagnosis of diabetic foot wound, pressure wound, venous leg wound, burn wound, or alternative diagnosis other than "open wound"
3. Presence of systemic infection, sepsis, or osteomyelitis at screening.
4. Multiple wounds at the same site of the referenced wound with < 2 cm separation from the target ulcer.
5. 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.
6. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound.
7. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
8. Known contraindications or hypersensitivity to amniotic membrane products or components of NeoThelium FT.
9. Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P interfering with wound treatment and/or healing.
10. Subject is pregnant or breastfeeding
11. 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
12. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to enrollment
13. Index ulcer suspicious of neoplasm in the opinion of the principal investigator
14. Open wound with active infection
15. Wound depth with visible exposed bone
16. Index wound 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 + SOC

Experimental group

Description:

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

Treatment:

Other: NeoThelium FT