Evaluating the Efficacy of NeoThelium FT in the Treatment of Chronic Open Wounds (NCT06918561) | Clinical Trial Compass
RecruitingNot Applicable
Evaluating the Efficacy of NeoThelium FT in the Treatment of Chronic Open Wounds
United States132 participantsStarted 2025-10-16
Plain-language summary
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 chronic open wounds.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or Female, 18 years of age or older
. Subject has a medical diagnosis of "other" Open wound
. 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
. Subject has a chronic open wound with a historical wound measurement showing less than 25% healing within 14 days prior to screening
. Subject has a chronic open wound with screening wound measurement showing less than 25% healing within 14 days prior to randomization
. Subject has an Open wound without infection or clinically visible exposed bone
. Index wound is a minimum of 0.5cm2 and a maximum of 25cm2 at first treatment visit
. Index ulcer has a maximum depth of 1cm at screening visit 1
Exclusion criteria
. Subject with a wound diagnosis of diabetic foot wound, pressure wound, venous leg wound, burn wound, or alternative diagnosis other than "open wound"
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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 product interfering with wound treatment and/or healing