Loading clinical trials...

Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers | Clinical Trials | Clareo Health

RECRUITINGNA

Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers

Evaluating the Efficacy and Safety of NeoThelium FT Amnion Skin Graft in the Management of Diabetic Foot Ulcers: A Prospective Case Series

NCT07039396•NuScience Medical Biologics, LLC

View on ClinicalTrials.gov

Summary

This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Diabetic Foot Ulcers

Detailed Description

This research will take place across multiple medical centers, where both researchers and participants will know which treatment is being used (open label). Patients who agree to participate and meet the study requirements during screening will begin SOC plus NeoThelium FT weekly applications. The subject will continue follow-up per the original schedule. As this is a post-marketing study, it will gather information regarding the efficacy of treatment while also supporting insurance reimbursement decisions.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or Female, 18 years of age or older
•2. Subject has a medical diagnosis of Type I or Type II Diabetes Mellitus requiring oral or glycemic control and/or insulin replacement therapy with a diabetic foot ulcer
•3. Subject has a diabetic foot ulcer of Wagner grade 1, 2, or 3 without infection or clinically visible exposed bone. Wagner 3 is acceptable if the diagnosis is acute osteomyelitis and the subject has successfully completed IV antibiotic treatment prior to screening.
•4. Ulcer area is a minimum of 0.5 cm2 and a maximum of 25 cm2 at first treatment visit
•5. Subject is able and willing to follow the protocol requirements
•6. Subject had signed informed consent
•7. Adequate circulation if wound is location on the lower extremity demonstrated by an ABI of \>0.7 and \<1.3, or TBI of \>0.6 within 30 days prior to informed consent OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to the first treatment visit.
•8. Diabetic foot ulcer is being treated with TCC offloading therapy OR Fixed Ankle Walker if approved by Medical Monitor for 7 days prior to treatment visit 1
•9. Wound free of clinical infection (no purulent discharge, cellulitis, or osteomyelitis) post-debridement.
•10. Record of serum hemoglobin A1c within 90 days prior to the first treatment visit

Exclusion Criteria

•1. Subject is unable to comply with protocol treatment
•2. Target ulcer is a Wagner 3 of acute osteomyelitis that has not been successfully treated with 6 weeks of IV antibiotics or is diagnosed as chronic refractory osteomyelitis.
•3. Wagner 3, 4, or 5 involving tendon, bone, or joint.
•4. Presence of systemic infection, sepsis, or osteomyelitis at screening.
•5. Multiple DFUs on the same foot with \< 2 cm separation from the target ulcer.
•6. Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing.
•7. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound.
•8. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
•9. Known contraindications or hypersensitivity to amniotic membrane products or components of NeoThelium FT.
•10. Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P interfering with wound treatment and/or healing.
+4 more criteria

Locations (3)

MedCentris of Alexandria

Alexandria, Louisiana, United States

MedCentris of Leesville

Leesville, Louisiana, United States

MedCentris of Many

Many, Louisiana, United States

Key Dates

Start Date

August 26, 2025

Primary Completion Date

May 1, 2026

Completion Date

June 1, 2026

Last Updated

March 12, 2026

Enrollment

ESTIMATED participants

Conditions

Diabetic Foot Ulcer

Interventions

NeoThelium FT (HCT/P 361)

OTHER

Contacts

Angelina Ferguson, DNP

CONTACT

986-629-4013 info@sygnola.com

Sarah Moore, MBE

CONTACT

986-629-4013 info@sygnola.com

Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers

NCT07396376

Diabetic Foot UlcerWagner Grade 1 - 2+2 more

View study

RECRUITINGNA

Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers

NCT07116876

Diabetic Foot Ulcer (DFU)Lower Extremity

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers

Inclusion Criteria

Exclusion Criteria

Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers

Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers

Efficacy and Safety of Cold Atmospheric Plasma Combined With Endovascular Intervention for Diabetic Foot Ulcers With Lower Extremity Arterial Occlusion

Nonhealing Diabetic Foot Ulcers Treated With Standard of Care (SOC) Alone or Standard of Care and Amnion-Intermediate-Chorion (AIC)

Custom Insole With Transcutaneous Electrical Nerve Stimulation on Clinical Outcomes of Diabetic Foot Ulcers

Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy