Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-24 @ 12:36 PM
NCT ID:
NCT06918561
Eligibility Criteria:
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), and less than 12 months duration if being treated with continuous SOC
4. Subject has a chronic open wound with a historical wound measurement showing less than 25% healing within 14 days prior to screening
5. Subject has a chronic open wound with screening wound measurement showing less than 25% healing within 14 days prior to randomization
6. Subject has an Open wound without infection or clinically visible exposed bone
7. Index wound is a minimum of 0.5cm2 and a maximum of 25cm2 at first treatment visit
8. Index ulcer has a maximum depth of 1cm at screening visit 1
9. The chronic open wound is treated with offloading therapy, if applicable to location, while standing, sitting, and lying down for 14 days prior to randomization
10. Adequate circulation of wounds located below the knee 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.
11. Index ulcer is free of infection prior to randomization and during screening phase.
12. Index ulcer is free of necrotic debris prior to NeoThelium FT application
13. Female subjects of childbearing potential having a negative pregnancy test prior to randomization
14. Index ulcer is free of infection prior to randomization and during screening phase noted with the NERDS Assessment. Infection must be adequately treated and controlled prior to randomization.
15. Subject is able and willing to follow the protocol requirements
16. Subject had signed informed consent
17. If 2 or more ulcers are present, the ulcers must be separated by at least 2 cm
Exclusion Criteria:
1. Subject with a wound diagnosis of diabetic foot wound, pressure wound, venous leg wound, burn wound, or alternative diagnosis other than "open wound"
2. Subject has a known life expectancy of \<1 year
3. Subject is unable to comply with protocol treatment
4. 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.
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 to tissue-engineered allograft
8. Concurrent participation in alternative clinical trial that involves investigational drug or product 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 wound surface for \>2 weeks duration within 30 days prior to randomization; 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 randomization
12. Open wound with active infection
13. Wound depth with visible exposed bone
14. HBOT within 14 days prior to randomization
15. Revascularization surgery on the index wound leg within 30 days of screening phase
16. Index wound suspicious of neoplasm in the opinion of the principal investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06918561
Study Brief:
Protocol Section:
NCT06918561