Actively Recruiting
Evaluation of the Efficacy of NeoThelium FT in the Healing of Chronic Diabetic Foot Ulcers: A Randomized Controlled Multicenter Crossover Trial
Led by NuScience Medical Biologics, LLC · Updated on 2026-05-06
132
Participants Needed
8
Research Sites
4 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 care compared to standard care alone in treating diabetic foot ulcers. This randomized controlled crossover trial is open label and takes place across multiple medical centers. The study aims to gather information on wound healing rates and support insurance reimbursement decisions by measuring complete wound closure and other wound-related outcomes. Participants will be randomly assigned to receive either standard care alone or standard care plus weekly NeoThelium FT applications. Standard care includes wound cleansing, sharps debridement, moisture balancing dressings, and offloading. Subjects in the standard care group who do not achieve complete wound closure by day 84 may cross over to receive NeoThelium FT with standard care for up to 12 weekly treatments. The study includes a two-week screening phase before randomization. Participants will undergo regular wound assessments, pain evaluations on specific days, and follow-up visits according to the study schedule. Researchers will monitor wound healing progress including wound area changes and time to closure. The primary outcome is the percentage of ulcers completely closed within 12 weeks. Secondary outcomes include wound area reduction and pain assessments. The trial is expected to run until October 2026.
CONDITIONS
Brief 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, 18 years of age or older
- Diagnosis of Type I or Type II Diabetes Mellitus requiring oral or insulin therapy
- Diabetic foot ulcer present for 4 weeks or more, less than 12 months if treated with continuous standard care
- Ulcer shows less than 25% healing in 14 days prior to screening and prior to randomization
- Ulcer of Wagner grade 1, 2, or 3 without infection or visible exposed bone
- Wagner 3 ulcers acceptable if acute osteomyelitis successfully treated with IV antibiotics
- Index ulcer size between 0.5cm2 and 25cm2 at first treatment visit
- Ulcer treated with offloading therapy for at least 14 days prior to randomization
- Adequate circulation shown by ABI >0.7 and <1.3 or TBI >0.6 or arterial ultrasound within prescribed time
- Index ulcer free of infection and necrotic debris prior to randomization and screening
- Female subjects of childbearing potential with negative pregnancy test prior to randomization
- Ability and willingness to follow protocol
- Signed informed consent
- If multiple ulcers, they must be at least 2 cm apart
You will not qualify if you...
- Life expectancy less than 1 year
- Unable to comply with protocol treatment
- Major uncontrolled medical disorders affecting wound healing
- Active or history of malignancy or radiation therapy at wound site
- Comorbid conditions compromising safety
- Known contraindications to tissue-engineered allograft
- Participation in another clinical trial interfering with wound treatment
- Pregnant or breastfeeding
- Recent immunosuppressant treatment or anticipated use during study
- Wounds treated with CAMPs or tissue-engineered materials within 30 days
- Wagner 3 ulcers with active infection or chronic refractory osteomyelitis
- Wound depth with visible exposed bone
- Hyperbaric oxygen therapy within 14 days prior to randomization
- Revascularization surgery on the ulcer leg within 30 days prior to screening
- Ulcer suspicious for neoplasm per investigator opinion
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 screening and enrollment visit
Duration - Up to 24 weeks including crossover treatment
Participants receive either standard of care alone or standard of care plus NeoThelium FT to promote healing of diabetic foot ulcers. Participants in the standard of care arm who do not achieve wound closure after approximately 12 weeks may cross over to receive NeoThelium FT treatment with weekly applications for up to 12 weeks.
Weekly visits for treatment applications and assessments for up to 24 weeks
Duration - Up to 12 weeks after treatment
Participants are followed to assess wound healing progress, pain, and safety after treatment completion.
Follow-up visits at Day 0, Day 14, Day 35, Day 56, and Day 84 for pain assessment and wound evaluation
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
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here