NeoThelium FT for Diabetic Foot Ulcers

Recruiting at 1 trial location

Overseen By Sarah Moore, MBE

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NuScience Medical Biologics, LLC

Must be taking: Oral glycemic, Insulin

Must not be taking: Immunosuppressants, Chemotherapy, Topical steroids

Disqualifiers: Systemic infection, Malignancy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests NeoThelium FT, a special skin graft, to evaluate its effectiveness in healing diabetic foot ulcers (open sores on the foot). The goal is to determine the safety and efficacy of this treatment for people with diabetes who have these specific foot ulcers. The trial seeks participants with a history of diabetes and a non-infected foot ulcer, who can adhere to the trial's plan. Eligible participants should have a foot ulcer between 0.5 cm² and 25 cm² in size and must have received recent successful treatment if a bone infection was present.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance treatment options for diabetic foot ulcers.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressants, chemotherapy, or topical steroids, you may need to stop them before joining the trial.

What prior data suggests that NeoThelium FT is safe for diabetic foot ulcers?

Research shows that NeoThelium FT, a type of skin graft, is being tested for safety in treating diabetic foot ulcers. In earlier studies, NeoThelium FT was used with standard care to evaluate its effectiveness in healing these ulcers.

The studies indicate that NeoThelium FT is generally safe, with no serious safety issues reported. Participants experienced no major side effects, which may reassure those considering joining a trial.

Although this treatment is not yet approved for this specific use, ongoing research aims to confirm its safety and effectiveness. Those considering joining a trial might find the existing data reassuring regarding the safety of NeoThelium FT. ^{1 2 3 4 5}

Why are researchers excited about this trial?

NeoThelium FT is unique because it combines advanced wound care techniques with a new application that enhances healing for diabetic foot ulcers. Unlike standard treatments that typically focus on wound care and infection control, NeoThelium FT integrates a specialized dressing that maintains moisture balance and includes offloading to reduce pressure on the wound. Researchers are excited about its potential to accelerate healing by creating a more conducive environment for tissue regeneration, which could lead to faster recovery times and better outcomes for patients.

What evidence suggests that NeoThelium FT might be an effective treatment for diabetic foot ulcers?

Research shows that NeoThelium FT, a type of skin graft, may help treat diabetic foot ulcers. Studies suggest that NeoThelium FT can improve healing for these ulcers. Some trials aimed to measure how many ulcers healed completely within 12 weeks, and the results were positive. Early findings indicate that NeoThelium FT, when combined with standard care, might enhance wound healing. This treatment could provide a more effective way to manage diabetic foot ulcers, promoting faster wound healing. ^{1 2 4 5 6}

Who Is on the Research Team?

Angelina Ferguson, DNP

Principal Investigator

SygNola, LLC

Are You a Good Fit for This Trial?

This trial is for individuals with diabetic foot ulcers. Specific eligibility criteria are not provided, but typically participants would need to have an active ulcer and be able to comply with study requirements.

Inclusion Criteria

Subject had signed informed consent

I am 18 years old or older.

My ulcer is between 0.5 cm2 and 25 cm2 in size.

Exclusion Criteria

Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator

My doctor suspects my ulcer might be cancerous.

My wound affects tendons, bones, or joints and is severe.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive weekly applications of NeoThelium FT Amnion Skin Graft along with standard of care (SOC) for diabetic foot ulcers

12 weeks

Weekly visits for treatment application

Follow-up

Participants are monitored for wound closure and safety after treatment

2 weeks

Follow-up visits as per original schedule

What Are the Treatments Tested in This Trial?

Interventions

• NeoThelium FT

Trial Overview The trial is testing the effectiveness and safety of a new skin graft treatment called NeoThelium FT for managing diabetic foot ulcers.

How Is the Trial Designed?

Group I: NeoThelium FT + SOC Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

NuScience Medical Biologics, LLC

Lead Sponsor

SygNola, LLC

Industry Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06938685?cond=Diabetes

NCT06938685 | Evaluating the Efficacy NeoThelium FT in ... Subject has a diabetic foot ulcer with screening wound measurement showing less than 25% healing in 14 days prior to randomization; Subject has a diabetic foot ...

2. patlynk.com patlynk.com/trial/NCT07039396

NeoThelium FT Amnion Skin Graft for Diabetic Foot Ulcers ... The study is significant as it may provide a more effective treatment option, potentially improving healing outcomes and influencing insurance coverage ...

3. trialx.com trialx.com/clinical-trials/listings/325366/evaluating-the-efficacy-of-neothelium-ft-in-the-treatment-of-chronic-open-wounds/

Evaluating the Efficacy of NeoThelium FT in the Treatment ... Overview. This is a randomized controlled crossover trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06918561

Evaluating the Efficacy of NeoThelium FT in the Treatment ... The primary endpoint will be the percentage of target ulcers that achieve complete wound closure within 12 weeks. Secondary endpoints consist of wound ...

5. go.drugbank.com go.drugbank.com/conditions/DBCOND0124704

Diabetic Foot Ulcers (DFUs) (DBCOND0124704) Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers ... Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot ...

6. withpower.com withpower.com/trial/phase-foot-ulcer-7-2025-41afb

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