Actively Recruiting
A Randomized Controlled Multisite Crossover Trial Evaluating the Efficacy of NeoThelium FT in the Treatment of "Other" Open Wounds
Led by NuScience Medical Biologics, LLC · Updated on 2026-05-06
132
Participants Needed
14
Research Sites
8 weeks
Total Duration
On this page
Sponsors
N
NuScience Medical Biologics, LLC
Lead Sponsor
S
SygNola, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of NeoThelium FT combined with standard of care compared to standard of care alone in treating chronic open wounds. This randomized controlled crossover trial is open label, meaning both researchers and participants know which treatment is given. The study aims to collect information on wound healing and pain while supporting insurance reimbursement decisions across multiple medical centers. Participants will be randomly assigned to one of two groups: standard of care (SOC) alone or SOC plus NeoThelium FT. Those in the SOC group who do not achieve complete wound closure by about 84 days may cross over to receive NeoThelium FT along with SOC for up to 12 weekly treatments. Treatments include wound cleansing, debridement, dressings, and offloading, with NeoThelium FT being a special membrane derived from donated human placental tissue. Participants will undergo a two-week screening before randomization and then receive treatments and follow-up visits for up to 12 weeks. Assessments include measuring wound closure, wound size reduction, and pain levels at multiple time points. Researchers will monitor wound healing progress and safety throughout the study, which may last several months depending on individual response and crossover status.
CONDITIONS
Brief Title
Evaluating the Efficacy of NeoThelium FT in the Treatment of Chronic Open Wounds
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Diagnosed with "other" open wound
- Chronic open wound present for 4 weeks or longer and less than 12 months if treated with continuous standard of care
- Wound has shown less than 25% healing within 14 days prior to screening and randomization
- Open wound without infection or clinically visible exposed bone
- Wound size between 0.5 cm² and 25 cm² at first treatment
- Wound depth no greater than 1 cm at screening
- Offloading therapy used for wounds below the knee when applicable for at least 14 days prior to randomization
- Adequate circulation confirmed by specific tests within 30 to 90 days prior to randomization
- Wound free of infection and necrotic debris before treatment
- Negative pregnancy test for women of childbearing potential
- Ability and willingness to follow study protocol
- Signed informed consent
- Multiple ulcers must be at least 2 cm apart
You will not qualify if you...
- Wound diagnosed as diabetic foot, pressure, venous leg, or burn wound, or other than "open wound"
- Life expectancy less than 1 year
- Unable to comply with study protocol
- Major uncontrolled medical disorders affecting wound healing
- Active or past malignant disease or radiation at wound site
- Conditions compromising safety per investigator
- Contraindications to tissue-engineered allograft
- Participation in another interfering clinical trial
- Pregnant or breastfeeding
- Recent immunosuppressant, chemotherapy, or topical steroid use
- Recent treatment with tissue-engineered or scaffold wound materials
- Active wound infection
- Wound depth with exposed bone
- Recent hyperbaric oxygen therapy
- Recent revascularization surgery on wound leg
- Suspected neoplasm at wound site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks for initial treatment; crossover treatment up to 12 weeks if eligible
Participants receive either standard wound care alone or standard wound care plus NeoThelium FT applications. Those initially on standard care who do not achieve wound closure by about 12 weeks may crossover to receive NeoThelium FT with standard care for up to 12 weekly treatments.
Weekly visits during treatment phase
Duration - Up to 12 weeks post treatment start
Participants continue follow-up assessments after treatment to monitor wound healing and pain.
Visits on Day 0, Day 14, Day 35, Day 56, and Day 84
Trial Site Locations
Total: 14 locations
1
MedCentris of Denham Springs
Denham Springs, Louisiana, United States, 70726
Actively Recruiting
2
MedCentris of Hammond
Hammond, Louisiana, United States, 70403
Actively Recruiting
3
MedCentris of Carencro
Lafayette, Louisiana, United States, 70507
Actively Recruiting
4
MedCentris of Leesville
Leesville, Louisiana, United States, 71146
Actively Recruiting
5
MedCentris of Many
Many, Louisiana, United States, 71449
Actively Recruiting
6
MedCentris of Marksville
Marksville, Louisiana, United States, 71351
Actively Recruiting
7
MedCentris of Metairie
Metairie, Louisiana, United States, 70001
Actively Recruiting
8
MedCentris of Minden
Minden, Louisiana, United States, 71055
Actively Recruiting
9
MedCentris of Slidell
Slidell, Louisiana, United States, 70458
Actively Recruiting
10
MedCentris of D'iberville
D'Iberville, Mississippi, United States, 39540
Actively Recruiting
11
MedCentris of McComb
McComb, Mississippi, United States, 39648
Actively Recruiting
12
MedCentris of Natchez
Natchez, Mississippi, United States, 39120
Completed
13
MedCentris of Southaven
Southaven, Mississippi, United States, 38671
Actively Recruiting
14
Northeast Podiatry Consultant
Brooklyn, New York, United States, 11234
Actively Recruiting
Research Team
A
Angelina Ferguson, DNP
S
Sarah Moore, MBE
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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