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Tests treatment safety and results for Open Wound
Official title Evaluating the Efficacy of NeoThelium FT in the Treatment of Chronic Open Wounds
ClinicalTrials.gov ID: NCT06918561
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- Subject with a wound diagnosis of diabetic foot wound, pressure wound, venous leg wound, burn wound, or alternative diagnosis other than "open wound"
- 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...
- 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
See the full eligibility 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
- 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
- Adequate circulation of wounds located below the knee demonstrated by an ABI of \>0.7 and \ 0.6 within 30 days prior to randomization OR an arterial ultrasound noted with patent circulation and without significant...
- Index ulcer is free of infection prior to randomization and during screening phase.
- Index ulcer is free of necrotic debris prior to NeoThelium FT application
- Female people of childbearing potential having a negative pregnancy test prior to randomization
- 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.
- 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
- Subject with a wound diagnosis of diabetic foot wound, pressure wound, venous leg wound, burn wound, or alternative diagnosis other than "open wound"
- 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...
- 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 wound surface for \>2 weeks duration within 30 days prior...
- Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization
- Open wound with active infection
- Wound depth with visible exposed bone
- HBOT within 14 days prior to randomization
- Revascularization surgery on the index wound leg within 30 days of screening phase
- Index wound suspicious of neoplasm in the opinion of the principal investigator
The study team makes the final eligibility decision.
Where it's taking place
- Denham Springs, Louisiana, United States
- Hammond, Louisiana, United States
- Lafayette, Louisiana, United States
- Leesville, Louisiana, United States
- Many, Louisiana, United States
- Marksville, Louisiana, United States
- Metairie, Louisiana, United States
- Minden, Louisiana, United States
- Slidell, Louisiana, United States
- D'Iberville, Mississippi, United States
- McComb, Mississippi, United States
- Natchez, Mississippi, United States
- Southaven, Mississippi, United States
- Brooklyn, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denham Springs, Louisiana, United States; Hammond, Louisiana, United States; Lafayette, Louisiana, United States; Leesville, Louisiana, United States; Many, Louisiana, United States; Marksville, Louisiana, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.