What is NeoThelium FT studying for diabetic foot ulcers?

NeoThelium FT is being studied as a treatment for diabetic foot ulcers to evaluate its safety and effectiveness. Researchers aim to understand how this skin graft helps wounds heal and supports insurance reimbursement decisions. The study is sponsored by NuScience Medical Biologics, LLC and conducted in multiple medical centers.

Who may be eligible for this diabetic foot ulcer clinical trial?

Adults aged 18 years or older with Type I or Type II Diabetes and a diabetic foot ulcer may be eligible. The study includes participants of any gender with specific ulcer sizes and no infection. Key requirements include adequate blood flow to the wound area and willingness to follow study procedures. Please review eligibility criteria for more details.

Is there any cost to participate in this diabetic foot ulcer clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can expect to receive treatments and assessments without charge during the trial.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID07039396

Evaluating Safety and Effectiveness of NeoThelium FT Amnion Skin Graft for Treating Diabetic Foot Ulcers in Adults A Prospective Case Series

Led by NuScience Medical Biologics, LLC · Updated on 2026-03-12

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the use of NeoThelium FT Amnion Skin Graft in managing diabetic foot ulcers. This prospective case series aims to assess the safety and effectiveness of this treatment in patients with diabetes who have foot ulcers. The study is open label and conducted across multiple medical centers, focusing on gathering evidence to support insurance coverage decisions. Participants will receive standard care combined with weekly applications of NeoThelium FT, which is a dehydrated membrane made from donated human placental tissue. The treatment includes wound cleansing, sharp debridement, application of the graft, dressing to maintain moisture balance, and offloading to protect the wound. Patients continue follow-up visits according to the original schedule, with close monitoring throughout the study. During the trial, researchers will track wound healing progress, including the time to complete wound closure within 1 to 12 weeks. They will also measure changes in wound area, hemoglobin A1c levels, and follow-up wound closure two weeks after treatment. Safety and treatment effectiveness are monitored with regular assessments, and participation may last up to 12 weeks or more depending on healing progress.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

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 of Wagner grade 1, 2, or 3 without infection or visible exposed bone; Wagner 3 allowed if acute osteomyelitis treated with IV antibiotics
Ulcer area between 0.5 cm2 and 25 cm2 at first treatment
Ability and willingness to follow study protocol
Signed informed consent
Adequate circulation in lower extremity confirmed by ABI >0.7 and <1.3, or TBI >0.6 within 30 days, or arterial ultrasound within 90 days
Ulcer treated with total contact cast offloading or fixed ankle walker approved 7 days before treatment
Wound free of clinical infection post-debridement
Serum hemoglobin A1c recorded within 90 days prior to first treatment

You will not qualify if you...

Unable to comply with protocol treatment
Wagner 3 ulcer with untreated or chronic refractory osteomyelitis
Wagner grades 3, 4, or 5 involving tendon, bone, or joint
Presence of systemic infection, sepsis, or osteomyelitis at screening
Multiple diabetic foot ulcers on same foot less than 2 cm apart
Major uncontrolled medical disorders affecting wound healing
Active or history of malignant disease or radiation at wound site
Comorbid conditions compromising safety
Known allergy to amniotic membrane products or NeoThelium FT components
Participation in another clinical trial involving investigational drugs or products affecting wound healing
Pregnant or breastfeeding
Recent use or anticipated use of immunosuppressants, chemotherapy, or topical steroids to ulcer
Wound treated with tissue-engineered or scaffold materials within 30 days prior
Ulcer suspected to be a tumor by investigator

Research Team

Angelina Ferguson, DNP

Sarah Moore, MBE

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Evaluating Safety and Effectiveness of NeoThelium FT Amnion Skin Graft for Treating Diabetic Foot Ulcers in Adults A Prospective Case Series

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria