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Tests treatment safety and results for Diabetic Foot Ulcer
Official title Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers
ClinicalTrials.gov ID: NCT07039396
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 Diabetic Foot 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 Type I or Type II Diabetes Mellitus requiring oral or glycemic control and/or insulin replacement therapy with a...
- Subject has a diabetic foot ulcer of Wagner grade 1, 2, or 3 without infection or clinically visible exposed bone. Wagner 3 is acceptable if the...
- Ulcer area is a minimum of 0.5 cm2 and a maximum of 25 cm2 at first treatment visit
- Subject is able and willing to follow the protocol requirements
You likely can't join if
- Subject is unable to comply with protocol treatment
- Target ulcer is a Wagner 3 of acute osteomyelitis that has not been successfully treated with 6 weeks of IV antibiotics or is diagnosed as chronic...
- Wagner 3, 4, or 5 involving tendon, bone, or joint.
- Presence of systemic infection, sepsis, or osteomyelitis at screening.
- Multiple DFUs on the same foot with \< 2 cm separation from the target ulcer.
- Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary...
See the full eligibility criteria
- Male or Female, 18 years of age or older
- Subject has a medical diagnosis of Type I or Type II Diabetes Mellitus requiring oral or glycemic control and/or insulin replacement therapy with a diabetic foot ulcer
- Subject has a diabetic foot ulcer of Wagner grade 1, 2, or 3 without infection or clinically visible exposed bone. Wagner 3 is acceptable if the diagnosis is acute osteomyelitis and the subject has successfully...
- Ulcer area is a minimum of 0.5 cm2 and a maximum of 25 cm2 at first treatment visit
- Subject is able and willing to follow the protocol requirements
- Subject had signed informed consent
- 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...
- Diabetic foot ulcer is being treated with TCC offloading therapy OR Fixed Ankle Walker if approved by Medical Monitor for 7 days prior to treatment visit 1
- Wound free of clinical infection (no purulent discharge, cellulitis, or osteomyelitis) post-debridement.
- Record of serum hemoglobin A1c within 90 days prior to the first treatment visit
- Subject is unable to comply with protocol treatment
- Target ulcer is a Wagner 3 of acute osteomyelitis that has not been successfully treated with 6 weeks of IV antibiotics or is diagnosed as chronic refractory osteomyelitis.
- Wagner 3, 4, or 5 involving tendon, bone, or joint.
- Presence of systemic infection, sepsis, or osteomyelitis at screening.
- Multiple DFUs on the same foot with \< 2 cm separation from the target ulcer.
- 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 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
- Alexandria, Louisiana, United States
- Leesville, Louisiana, United States
- Many, 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 Alexandria, Louisiana, United States; Leesville, Louisiana, United States; Many, 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.