Venous Leg Ulcer
Conditions
Keywords
Chronic wounds, Wound Medicine, Cellular, Acellular, Matrix-like Product (CAMP), Cellular and/or Tissue Product (CTP), Dehydrated Complete Human Placental Membrane (dCHPM)
Brief summary
This is a randomized controlled trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating 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 be randomly assigned to one of two groups: either standard of care alone, or standard of care plus NeoThelium FT. As this is a post-marketing study, it will gather information about how effective the treatment is in treating venous leg ulcers. All subjects will complete two week screening phase prior to being randomized into a treatment arm. Treatment arms will consist of NeoThelium FT in conjunction with standard of care, vs. standard of care alone. The primary endpoint will be the percentage of target ulcers that achieve complete wound closure within 16 weeks. Secondary endpoints consist of wound area reduction rates, time to closure, follow-up closure, and pain assessment.
Interventions
OTHERStandard of Care
Wound cleansing, Sharps debridement, Dressing for moisture balance, Offloading
OTHERNeoThelium FT
NeoThelium FT is a dehydrated wound covering derived from donated human placental tissue. NeoThelium FT is a dual-layer membrane with amnion and chorion combination layers.
Sponsors
NuScience Medical Biologics, LLC
SygNola, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The subject will be randomized to one of the following treatments: * Standard of care * 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 Insufficiency with an open wound to the lower extremity 3. Subject has a Venous Leg Ulcer present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC 4. Subject has a Venous Leg Ulcer with a historical wound measurement showing less than 50% healing in 30 days prior to randomization 5. Subject has a Venous Leg Ulcer with screening wound measurement showing less than 25% healing in 14 days prior to randomization 6. Subject has a Venous Leg Ulcer Wagner 1, 2, and 3 without infection or clinically visible exposed bone 7. Index ulcer is a minimum of 1cm2 and a maximum of 40cm2 at first treatment visit 8. Venous Leg Ulcer is being treated with compression therapy for 14 days prior to randomization 9. Adequate circulation of ulcer demonstrated by an ABI of \>0.7 and \<1.3, or TBI of \>0.6 within 30 days prior to randomization 10. 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. 11. Index ulcer is free of necrotic debris prior to NeoThelium FT application 12. Female subjects of childbearing potential having a negative pregnancy test prior to randomization 13. Subject is able and willing to follow the protocol requirements 14. Subject had signed informed consent 15. If 2 or more ulcers are present, the ulcers must be separated by at least 1 cm
Exclusion criteria
1. Subject has a known life expectancy of \<1 year 2. Subject is unable to comply with protocol treatment 3. 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 wound healing 4. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound 5. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator 6. Known contraindications to tissue-engineered allograft 7. Concurrent participation in alternative clinical trial that involves investigational drug or product interfering with wound treatment and/or healing 8. Wound reduces in area by ≥25% after 14 days of SOC prior to randomization 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 randomization; 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 randomization 12. Venous Leg Ulcer with active infection 13. Wound depth with visible exposed bone 14. HBOT within 14 days prior to randomization 15. Revascularization surgery on the index ulcer leg within 30 days of screening phase 16. 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 digital photographic planimetry and physical examination. |
| Time to Closure | 1-12 weeks | Average number of grafts and/or weeks used to achieve wound closure |
| Follow-Up Closure | 2 weeks | Number of wounds remaining closed during the 2-week follow-up |
| Pain Assessment | Day 0, Day 14, Day 35, Day 56, Day 84 | Change in pain associated with the target ulcer will be assessed using the Numeric Pain Rating Scale at designated time points |
Contacts
CONTACTAngelina Ferguson, DNP
CONTACTSarah Moore, MBE
STUDY_DIRECTORAngelina Ferguson, DNP
SygNola, LLC
Outcome results
None listed