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Tests treatment safety and results for Pressure Injury
Official title Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Chronic Pressure Ulcers
ClinicalTrials.gov ID: NCT07158658
What this study is testing
- What it's testing
- This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Chronic Pressure Ulcers
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 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
You likely can't join if
- 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
- Known contraindications to tissue-engineered allograft
See the full eligibility 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 \ 0.6 within 30 days prior to the first treatment visit
- Index ulcer is free of infection prior to the first treatment visit 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 the first treatment visit
- 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 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 ulcer surface for \>14 days duration within 30 days prior...
- Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to the first treatment visit
- Pressure Injury/Ulcer of Stage 4 or active osteomyelitis
- Wound depth with visible exposed bone
- HBOT within 14 days prior to the first treatment visit
- Revascularization surgery on the index ulcer leg within 30 days of screening phase
- Index ulcer suspicious of neoplasm in the opinion of the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Bossier City, Louisiana, United States
- Rayville, Louisiana, 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 Bossier City, Louisiana, United States; Rayville, Louisiana, United States. 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.