Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Chronic Pressure Ulcers

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.

Inclusion criteria

• Male or Female, 18 years of age or older
• Subject has a medical diagnosis of Pressure Injury/Ulcer located on the pelvis or lower extremity
• Subject has a Pressure Injury/Ulcer Stage 2 or 3 without infection
• Index ulcer is a minimum of 1cm2 and a maximum of 30cm2 at first treatment visit
• Index ulcer has a depth of ≤ 1cm2, and subject is compliant to use continuous NPWT with 75-100mmHg, at the providers discretion
• Index ulcer has a depth of > 1cm2, and subject is compliant to use continuous NPWT with 75-100mmHg
• Pressure Injury/Ulcer is treated with offloading therapy while standing, sitting and lying down (if applicable to wound location) for 7 days prior to the first treatment visit
• Adequate circulation of ulcer, if located on the lower extremity, demonstrated by an ABI of >0.7 and <1.3, or TBI of >0.6 within 30 days prior to the first treatment visit
• Index ulcer is free of infection prior to the first treatment visit and during screening phase.
• Index ulcer is free of necrotic debris prior to NeoThelium FT application
• Female subjects of childbearing potential having a negative pregnancy test prior to the first treatment visit
• Subject is able and willing to follow the protocol requirements
• Subject had signed informed consent
• If 2 or more ulcers are present, the ulcers must be separated by at least 2 cm

Exclusion criteria

• Subject has a known life expectancy of <1 year
• Subject is unable to comply with protocol treatment
• 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 in the opinion of the investigator
• 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 to tissue-engineered allograft
• Concurrent participation in alternative clinical trial that involves investigational drug or product 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 >14 days 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 the first treatment visit
• Pressure Injury/Ulcer of Stage 4 or active osteomyelitis
• Wound depth with visible exposed bone
• HBOT within 14 days prior to the first treatment visit
• Revascularization surgery on the index ulcer leg within 30 days of screening phase
• Index ulcer suspicious of neoplasm in the opinion of the investigator