Actively Recruiting
Evaluating the Efficacy of NeoThelium FT in the Treatment of Chronic Open Wounds
Led by NuScience Medical Biologics, LLC · Updated on 2026-05-06
132
Participants Needed
14
Research Sites
50 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
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.
CONDITIONS
Official 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
- Have a medical diagnosis of "other" open wound
- Have a chronic open wound present for 4 weeks or more and less than 12 months if treated continuously with standard care
- Have a wound showing less than 25% healing in the 14 days before screening and before randomization
- Have an open wound without infection or visible exposed bone
- Wound size between 0.5 cm² and 25 cm² at first treatment
- Wound depth no more than 1 cm at screening
- Use offloading therapy if applicable for 14 days before randomization
- Have adequate circulation in wounds below the knee as measured within 30 to 90 days before randomization
- Wound free of infection and necrotic debris before treatment application
- Female participants of childbearing potential must have a negative pregnancy test before randomization
- Able and willing to follow study protocol
- Have signed informed consent
- If multiple wounds, ulcers must be at least 2 cm apart
You will not qualify if you...
- Wound diagnosed as diabetic foot, pressure, venous leg, burn wound, or other diagnosis besides "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 therapy at wound site
- Conditions compromising safety as determined by investigator
- Known contraindications to tissue-engineered allografts
- Participation in another clinical trial affecting wound treatment
- Pregnant or breastfeeding
- Recent immunosuppressant treatment, chemotherapy, or topical steroids within 30 days
- Wound treated with certain engineered products within 30 days
- Wound with active infection or visible exposed bone
- Hyperbaric oxygen therapy within 14 days
- Revascularization surgery on affected leg within 30 days
- Wound suspicious for cancer as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
S
Sarah Moore, MBE
CONTACT
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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