Actively Recruiting
Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers
Led by NuScience Medical Biologics, LLC · Updated on 2026-03-12
10
Participants Needed
3
Research Sites
39 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 prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Diabetic Foot Ulcers
CONDITIONS
Official Title
Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or Female, 18 years of age or older
- Diagnosed with Type I or Type II Diabetes Mellitus requiring oral or insulin therapy with a diabetic foot ulcer
- Diabetic foot ulcer classified as Wagner grade 1, 2, or 3 without infection or exposed bone; Wagner 3 acceptable if acute osteomyelitis was treated with IV antibiotics
- Ulcer size between 0.5 cm2 and 25 cm2 at first treatment visit
- Able and willing to follow the study protocol
- Signed informed consent
- Adequate lower extremity circulation shown by ABI >0.7 and <1.3, or TBI >0.6 within 30 days before consent, or arterial ultrasound within 90 days before treatment showing good circulation
- Ulcer treated with Total Contact Cast offloading therapy or Fixed Ankle Walker approved by Medical Monitor for 7 days before treatment
- Wound free of clinical infection after debridement
- Serum hemoglobin A1c test within 90 days before first treatment visit
You will not qualify if you...
- Unable to comply with the study treatment protocol
- Wagner 3 ulcer with acute osteomyelitis not treated successfully with 6 weeks of IV antibiotics or diagnosed as chronic refractory osteomyelitis
- Wagner grade 3, 4, or 5 ulcers involving tendon, bone, or joint
- Presence of systemic infection, sepsis, or osteomyelitis at screening
- Multiple diabetic foot ulcers on the same foot less than 2 cm apart from target ulcer
- Major uncontrolled medical disorders affecting wound healing as judged by the investigator
- Active treatment for cancer, history of malignancy, or radiation therapy at wound site
- Comorbid conditions that may risk participant safety as judged by investigator
- Known allergy or sensitivity to amniotic membrane products or NeoThelium FT components
- Participation in another clinical trial involving investigational drugs or wound healing products
- Pregnant or breastfeeding
- Recent or anticipated use of immunosuppressants, chemotherapy, or topical steroids on ulcer within 30 days prior to treatment
- Wounds treated with advanced tissue products within 30 days before enrollment
- Ulcer suspected of being cancerous by principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
MedCentris of Alexandria
Alexandria, Louisiana, United States, 71301
Actively Recruiting
2
MedCentris of Leesville
Leesville, Louisiana, United States, 71446
Actively Recruiting
3
MedCentris of Many
Many, Louisiana, United States, 71449
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
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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