Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Chronic Pressure … (NCT07158658) | Clinical Trial Compass
RecruitingNot Applicable
Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Chronic Pressure Ulcers
United States10 participantsStarted 2025-12-01
Plain-language summary
This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Chronic Pressure Ulcers
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 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
Exclusion criteria
. Subject has a known life expectancy of \<1 year
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 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