Venous Leg Ulcer
Conditions
Keywords
Chronic Wounds, Cellular, Acellular, Matrix-like Product (CAMP), Cellular and/or Tissue Product (CTP), Dehydrated Complete Human Placental Membrane (dCHPM)
Brief summary
This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Venous Leg Ulcers
Detailed description
This research will take place across multiple medical centers, where both researchers and participants will know which treatment is being used (open label). Patients who agree to participate and meet the study requirements during screening will begin SOC plus NeoThelium FT weekly applications. The subject will continue follow-up per the original schedule. As this is a post-marketing study, it will gather information regarding the efficacy of treatment while also supporting insurance reimbursement decisions.
Interventions
NeoThelium FT is a dehydrated wound covering derived from donated human placental tissue.
Sponsors
NuScience Medical Biologics, LLC
SygNola, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
NeoThelium FT in addition to Standard of Care
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or Female, 18 years of age or older 2. Subject has a medical diagnosis of venous leg ulcer or venous insufficiency with a lower extremity wound 3. Subject has an venous leg ulcer without infection or clinically visible exposed bone 4. Index wound is a minimum of 1 cm2 and a maximum of 30 cm2 at first treatment visit 5. Adequate circulation if wound is location on the lower extremity demonstrated by an ABI of \>0.7 and \<1.3, or TBI of \>0.6 within 30 days prior to informed consent OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to the first treatment visit. 6. Venous Leg Ulcer is being treated with compression therapy for 7 days prior to treatment visit 1 7. Index wound is free of necrotic debris prior to NeoThelium FT application 8. Female subjects of childbearing potential having a negative pregnancy test prior to the first treatment visit 9. Wound free of clinical signs/symptoms of infection (no purulent discharge or cellulitis) post-debridement during screening and prior to the first treatment visit. 10. Subject is able and willing to follow the protocol requirements 11. Subject had signed informed consent 12. If 2 or more wounds are present, the wounds must be separated by at least 2 cm
Exclusion criteria
1. Subject is unable to comply with protocol treatment 2. Presence of infection prior to screening. 3. Multiple VLUs on the same leg with \< 2 cm separation from the target ulcer. 4. 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 blood disorders 5. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound. 6. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator 7. Known contraindications or hypersensitivity to amniotic membrane products or components of NeoThelium FT. 8. Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P interfering with wound treatment and/or healing. 9. Subject is pregnant or breastfeeding 10. 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 to the first treatment visit; or anticipated use of the above during the course of the study 11. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to enrollment 12. Index ulcer suspicious of neoplasm in the opinion of the principal investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Wound Closure | 1-12 weeks | The primary endpoint will be the percentage of target ulcers that achieve complete wound closure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Wound Area Change | 1-12 weeks | The percentage change in wound area from TV-1 to TV-13 will be measured weekly using manual measurement utilizing a ruler and physical examination. |
| Follow-Up Closure | 2 weeks | Number of wounds remaining closed during the 2-week follow-up |
| Time to Closure | 1-12 weeks | Average number of grafts and/or weeks used to achieve wound closure |
Countries
United States
Contacts
CONTACTAngelina Ferguson, DNP
CONTACTSarah Moore
STUDY_CHAIRAngelina Ferguson
SygNola, LLC
Outcome results
None listed