Recruiting

NeoThelium FT Amnion Skin Graft for Diabetic Foot Ulcers Treatment

Study Aim

This study explores the use of NeoThelium FT Amnion skin grafts to treat diabetic foot ulcers, focusing on achieving complete wound closure.

What is being tested

NeoThelium FT (HCT/P 361)

Other

Who is being recruted

Cardiovascular Diseases+10

+ Diabetes Mellitus

+ Diabetic Angiopathies

Over 18 Years

+24 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: August 2025

See protocol details

Summary

Principal SponsorNuScience Medical Biologics, LLC

Study ContactAngelina Ferguson, DNPMore contacts

Last updated: March 13, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: August 26, 2025

Actual date on which the first participant was enrolled.

This study is focused on examining a new treatment method for diabetic foot ulcers using a product called NeoThelium FT, which is a type of skin graft made from amnion. Diabetic foot ulcers are a common and serious complication for individuals with diabetes, often leading to infections and, in severe cases, amputations. The aim is to determine how effective and safe NeoThelium FT is when used alongside standard care (SOC) in healing these ulcers. The study is significant as it may provide a more effective treatment option, potentially improving healing outcomes and influencing insurance coverage decisions. Participants in this study will receive weekly applications of NeoThelium FT in addition to their regular treatment. This is an open-label study, meaning both the medical team and participants know the treatment being administered. The researchers will observe and record the healing progress of the ulcers over time to assess the treatment's effectiveness. Since the study is conducted after the product has been marketed, it will also contribute valuable data to support insurance reimbursement for this treatment, helping to make it more accessible if proven effective.

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

NCT07039396

Principal SponsorNuScience Medical Biologics, LLC

Study ContactAngelina Ferguson, DNPMore contacts

Last updated: March 13, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesDiabetes MellitusDiabetic AngiopathiesDiabetic NeuropathiesEndocrine System DiseasesLeg UlcerSkin DiseasesSkin UlcerVascular DiseasesFoot UlcerSkin and Connective Tissue DiseasesDiabetic FootDiabetes Complications

Criteria

10 inclusion criteria required to participate

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

Male or Female, 18 years of age or older

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

Ulcer area is a minimum of 0.5 cm2 and a maximum of 25 cm2 at first treatment visit

Show More Criteria

14 exclusion criteria prevent from participating

Wagner 3, 4, or 5 involving tendon, bone, or joint

Subject with history of immunosuppressant treatment (systemic corticosteroids > 10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the ulcer surface for > 2 weeks duration within 30 days prior to the first treatment visit; or anticipated use of the above during the course of the study

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

Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Wound cleansing, sharps debridement, NeoThelium FT application, Dressing for moisture balance, Offloading

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Recruiting

MedCentris of Alexandria

Alexandria, United StatesOpen MedCentris of Alexandria in Google Maps

Recruiting

MedCentris of Leesville

Leesville, United States

Recruiting

MedCentris of Many

Many, United States

Recruiting

3 Study Centers