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Tests treatment safety and results for Venous Leg Ulcer
Official title Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Venous Leg Ulcers
ClinicalTrials.gov ID: NCT07061613
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 Venous Leg 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 venous leg ulcer or venous insufficiency with a lower extremity wound
- Subject has an venous leg ulcer without infection or clinically visible exposed bone
- Index wound is a minimum of 1 cm2 and a maximum of 30 cm2 at first treatment visit
- Adequate circulation if wound is location on the lower extremity demonstrated by an ABI of \>0.7 and \ 0.6 within 30 days prior to informed consent...
You likely can't join if
- Subject is unable to comply with protocol treatment
- Presence of infection prior to screening.
- Multiple VLUs on the same leg with \< 2 cm separation from the target ulcer.
- Subject has comorbid conditions that may compromise subject safety or wound healing in the opinion of the investigator, such as serious...
- 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 venous leg ulcer or venous insufficiency with a lower extremity wound
- Subject has an venous leg ulcer without infection or clinically visible exposed bone
- Index wound is a minimum of 1 cm2 and a maximum of 30 cm2 at first treatment visit
- Adequate circulation if wound is location on the lower extremity demonstrated by an ABI of \>0.7 and \ 0.6 within 30 days prior to informed consent OR an arterial ultrasound noted with patent circulation and without...
- Venous Leg Ulcer is being treated with compression therapy for 7 days prior to treatment visit 1
- Index wound 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
- Wound free of clinical signs/symptoms of infection (no purulent discharge or cellulitis) post-debridement during screening and 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 wounds are present, the wounds must be separated by at least 2 cm
- Subject is unable to comply with protocol treatment
- Presence of infection prior to screening.
- Multiple VLUs on the same leg with \< 2 cm separation from the target ulcer.
- Subject has comorbid conditions that may compromise subject safety or wound healing in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited...
- 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 or hypersensitivity to amniotic membrane products or components of NeoThelium FT.
- Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P 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 \>2 weeks duration within 30 days prior...
- Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to enrollment
- Index ulcer suspicious of neoplasm in the opinion of the principal investigator
The study team makes the final eligibility decision.
Where it's taking place
- Metairie, Louisiana, United States
- Slidell, 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 Metairie, Louisiana, United States; Slidell, 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.