Actively Recruiting
Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers
Led by NuScience Medical Biologics, LLC · Updated on 2026-05-06
132
Participants Needed
8
Research Sites
51 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 diabetic foot ulcers.
CONDITIONS
Official Title
Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Diagnosed with Type I or Type II Diabetes Mellitus requiring oral or insulin treatment
- Diabetic foot ulcer present for 4 weeks or more and less than 12 months if treated with continuous standard care
- Ulcer shows less than 25% healing in the 14 days prior to screening and randomization
- Ulcer of Wagner grade 1, 2, or 3 without infection or visible exposed bone; Wagner 3 allowed if acute osteomyelitis treated with IV antibiotics
- Ulcer size between 0.5 cm² and 25 cm² at first treatment
- Offloading therapy used for ulcer for 14 days before randomization
- Adequate blood circulation near ulcer shown by specific tests within 30 or 90 days prior
- Ulcer free of infection and necrotic debris before treatment
- Negative pregnancy test for females of childbearing potential
- Able and willing to follow study protocol
- Signed informed consent
- If multiple ulcers, each must be at least 2 cm apart
You will not qualify if you...
- Life expectancy less than 1 year
- Inability to comply with study treatment
- Major uncontrolled medical disorders affecting wound healing per investigator
- Active cancer treatment, history of malignancy, or radiation at wound site
- Other medical conditions compromising safety per investigator
- Known allergies or contraindications to tissue-engineered allografts
- Participation in other trials interfering with wound treatment or healing
- Pregnant or breastfeeding
- Recent or expected use of immunosuppressants, chemotherapy, or topical steroids near ulcer
- Prior treatment of wound with certain engineered materials within 30 days
- Wagner 3 ulcer with untreated infection or chronic refractory osteomyelitis
- Wound with visible exposed bone
- Hyperbaric oxygen therapy within 14 days before randomization
- Revascularization surgery on affected leg within 30 days before screening
- Ulcer suspected to be cancerous according to investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
MedCentris of Alexandria
Alexandria, Louisiana, United States, 71301
Actively Recruiting
2
MedCentris of Franklinton
Franklinton, Louisiana, United States, 70438
Actively Recruiting
3
MedCentris of Hammond
Hammond, Louisiana, United States, 70403
Actively Recruiting
4
MedCentris of Minden
Minden, Louisiana, United States, 71055
Actively Recruiting
5
MedCentris of Monroe
Monroe, Louisiana, United States, 71201
Actively Recruiting
6
MedCentris of Natchez
Natchez, Mississippi, United States, 39120
Completed
7
MedCentris of Picayune
Picayune, Mississippi, United States, 39466
Actively Recruiting
8
Pace Foot and Ankle Center
Bryn Mawr, Pennsylvania, United States, 19010
Completed
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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