Overview
This is a randomized controlled crossover trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating diabetic foot ulcers.
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 be randomly assigned to one of two groups: either standard of care (SOC) alone, or SOC plus NeoThelium FT.
The study includes a crossover component for subjects in the SOC arm. At treatment visit 13 (approximately 84 days post-randomization), SOC arm subjects not having achieved complete wound closure, and still meeting the inclusion/exclusion criteria, are eligible to cross over to the IP arm (SOC plus NeoThelium FT). Crossover subjects will begin IP arm treatment with weekly NeoThelium FT applications for up to 12 treatment visits. 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. All subjects will complete a two-week screening phase prior to being randomized into a treatment arm. Treatment arms will consist of NeoThelium FT in conjunction with standard of care, vs. standard of care alone. The primary endpoint will be the percentage of target ulcers that achieve complete wound closure within 12 weeks. Secondary endpoints consist of wound area reduction rates, time to closure, follow-up closure, and pain assessment.
Eligibility
Inclusion Criteria:
- Male or Female, 18 years of age or older
- Subject has a medical diagnosis of Type I or Type II Diabetes Mellitus requiring oral or glycemic control and/or insulin replacement therapy
- Subject has a diabetic foot ulcer present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC
- Subject has a diabetic foot ulcer with a historical wound measurement showing less than 25% healing in 14 days prior to screening
- Subject has a diabetic foot ulcer with screening wound measurement showing less than 25% healing in 14 days prior to randomization
- 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.
- Index ulcer is a minimum of 0.5cm2 and a maximum of 25cm2 at first treatment visit
- Diabetic foot ulcer is being treated with offloading therapy for 14 days prior to randomization
- Adequate circulation of ulcer demonstrated by an ABI of >0.7 and <1.3, or TBI of >0.6 within 30 days prior to randomization OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to randomization.
- Index ulcer is free of infection prior to randomization and during screening phase. Infection must be adequately treated and controlled as defined by Infectious Disease Society of America (IDSA) Guidelines PEDIS Grade 1.
- Index ulcer is free of necrotic debris prior to NeoThelium FT application
- Female subjects of childbearing potential having a negative pregnancy test prior to randomization
- 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 expectance 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
- 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 device 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 >2 weeks duration within 30 days prior to randomization; 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 randomization
- Diabetic foot ulcer of Wagner 3 grade with active acute infection that has not completed IV antibiotic treatment, or Wagner 3 grade with chronic refractory osteomyelitis
- Wound depth with visible exposed bone
- HBOT within 14 days prior to randomization
- Revascularization surgery on the index ulcer leg within 30 days of screening phase
- Index ulcer suspicious of neoplasm in the opinion of the principal investigator