Open Wound
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 crossover trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating chronic open wounds.
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 (SOC) alone, or SOC plus NeoThelium FT. The study includes a crossover component for subjects in the SOC arm. At treatment visit 13 (approximately 84 days post-randomization), SOC arm subjects not having achieved complete wound closure, and still meeting the inclusion/exclusion criteria, are eligible to cross over to the IP arm (SOC plus NeoThelium FT). Crossover subjects will begin IP arm treatment with weekly NeoThelium FT applications for up to 12 treatment visits. 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. 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 12 weeks. Secondary endpoints consist of wound percentage area reduction rates 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
CROSSOVER
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 "other" Open wound 3. Subject has a chronic open wound 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 chronic open wound with a historical wound measurement showing less than 25% healing within 14 days prior to screening 5. Subject has a chronic open wound with screening wound measurement showing less than 25% healing within 14 days prior to randomization 6. Subject has an Open wound without infection or clinically visible exposed bone 7. Index wound is a minimum of 0.5cm2 and a maximum of 25cm2 at first treatment visit 8. Index ulcer has a maximum depth of 1cm at screening visit 1 9. The chronic open wound is treated with offloading therapy, if applicable to location, while standing, sitting, and lying down for 14 days prior to randomization 10. Adequate circulation of wounds located below the knee demonstrated by an ABI of \>0.7 and \<1.3, or TBI of \>0.6 within 30 days prior to randomization OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to randomization. 11. Index ulcer is free of infection prior to randomization and during screening phase. 12. Index ulcer is free of necrotic debris prior to NeoThelium FT application 13. Female subjects of childbearing potential having a negative pregnancy test prior to randomization 14. 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. 15. Subject is able and willing to follow the protocol requirements 16. Subject had signed informed consent 17. If 2 or more ulcers are present, the ulcers must be separated by at least 2 cm
Exclusion criteria
1. Subject with a wound diagnosis of diabetic foot wound, pressure wound, venous leg wound, burn wound, or alternative diagnosis other than "open wound" 2. Subject has a known life expectancy of \<1 year 3. Subject is unable to comply with protocol treatment 4. 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. 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 to tissue-engineered allograft 8. Concurrent participation in alternative clinical trial that involves investigational drug or product 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 wound 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. Open wound with active infection 13. Wound depth with visible exposed bone 14. HBOT within 14 days prior to randomization 15. Revascularization surgery on the index wound leg within 30 days of screening phase 16. Index wound 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. |
| 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 |
Countries
United States
Contacts
CONTACTAngelina Ferguson, DNP
CONTACTSarah Moore, MBE
STUDY_DIRECTORAngelina Ferguson, DNP
SygNola, LLC
Outcome results
None listed