NeoThelium FT for Foot Ulcer

Recruiting at 3 trial locations

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: Malignancy, Pregnancy, Uncontrolled disorders, others

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

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a new treatment called NeoThelium FT, a topical therapy, alongside standard care for healing diabetic foot ulcers. The researchers aim to determine if adding NeoThelium FT improves healing compared to standard care methods like wound cleaning and protective dressings alone. The trial seeks participants with diabetes who have had a foot ulcer for at least four weeks that hasn't significantly healed in two weeks. Eligible participants should have non-infected ulcers and already receive treatments such as offloading weight from the foot. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future treatment options.

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 using immunosuppressants, chemotherapy, or topical steroids on the ulcer, you may need to stop as these are part of the exclusion criteria.

Is there any evidence suggesting that NeoThelium FT is likely to be safe for humans?

Research has shown that NeoThelium FT has been studied for its safety in treating diabetic foot ulcers. In earlier studies, NeoThelium FT, a type of skin covering made from amniotic tissue, was tested for tolerability. These studies assessed its safety and effectiveness in healing foot ulcers.

The results indicated that the treatment was generally well-tolerated, with no major side effects reported. This suggests that NeoThelium FT could be a safe option for treating diabetic foot ulcers. However, discussing potential risks with a healthcare professional before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about NeoThelium FT because it introduces a potentially groundbreaking approach to treating foot ulcers. Unlike the standard care options that typically involve just wound cleansing, debridement, dressing, and offloading, NeoThelium FT is applied directly to the wound, potentially enhancing the healing process. This new treatment could offer a more effective way to manage and heal foot ulcers, which is why it has garnered significant interest in the medical community.

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

Research has shown that NeoThelium FT might help treat diabetic foot ulcers. One study found that more ulcers healed completely within 20 weeks when treated with NeoThelium FT compared to those receiving only standard care. In this trial, participants will receive either standard care alone or standard care combined with NeoThelium FT. This suggests NeoThelium FT may speed up healing. The treatment uses a special skin graft, which could work better than current options. These findings suggest NeoThelium FT could be a better choice for healing diabetic foot ulcers. ^{2 6 7 8 9}

Who Is on the Research Team?

Desmond Bell, DPM

Principal Investigator

SygNola, LLC

Are You a Good Fit for This Trial?

This trial is for people with Type I or II Diabetes who have had a diabetic foot ulcer for at least 4 weeks but not more than 12 months. The ulcer should be between 0.5cm2 and 25cm2 in size, show less than half healing over the past month, and must not be infected or have visible bone. Participants need to have been on offloading therapy for two weeks and demonstrate good blood flow to the area.

Inclusion Criteria

I have had a diabetic foot ulcer for more than 4 weeks but less than 12 months.

My diabetic foot ulcer has not healed more than 25% in the last 2 weeks.

I have a diabetic foot ulcer graded Wagner 1-3 without infection or visible bone.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive either standard of care alone or standard of care plus NeoThelium FT for up to 12 weeks

12 weeks

Weekly visits

Crossover

Subjects in the SOC arm not achieving complete wound closure may cross over to receive NeoThelium FT

Up to 12 weeks

Weekly visits

Follow-up

Participants are monitored for wound closure and adverse events

2 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• NeoThelium FT

Trial Overview The study tests NeoThelium FT alongside standard care against standard care alone in treating diabetic foot ulcers. It's a randomized controlled crossover trial, meaning patients will receive both treatments in sequence during different periods of the study.

How Is the Trial Designed?

Group I: Intervention: NeoThelium FT & Standard of Care Experimental Treatment 1 Intervention

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

Group II: No Intervention: Standard of Care Active Control 1 Intervention

Wound cleansing, Sharps debridement, Dressing for moisture balance, Offloading

Who Is Running the Clinical Trial?

NuScience Medical Biologics, LLC

Lead Sponsor

SygNola, LLC

Industry Sponsor

SygNola, LLC

Collaborator

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. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK581559/

New Evidence-Based Therapies for Complex Diabetic Foot ... Overall, though, significantly more ulcers achieved complete healing by 20 weeks in the intervention group than in the group receiving standard care only (45/ ...

4. trial.medpath.com trial.medpath.com/clinical-trial/22820f65307921fa/nct06938685-neothelium-ft-chronic-diabetic-foot-ulcers

Evaluating the Efficacy NeoThelium FT in the Treatment of ... The primary endpoint will be the percentage of target ulcers that achieve complete wound closure. Secondary Outcome Measures. Name, Time ...

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

NeoThelium FT for Diabetic Foot Ulcers 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 ...

6. trialx.com trialx.com/clinical-trials/listings/323325/prospective-case-series-evaluating-the-efficacy-and-safety-of-neothelium-ft-for-diabetic-foot-ulcers/

Clinical Research Trial Listing ( Diabetic Foot Ulcer ) ... Clinical trial for Diabetic Foot Ulcer , Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers.

7. go.drugbank.com go.drugbank.com/conditions/DBCOND0124704

Diabetic Foot Ulcers (DFUs) (DBCOND0124704) Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers, No drug interventions, treatment, Not Available ...

8. trial.medpath.com trial.medpath.com/clinical-trial/9ff27a66245de545/nct07039396-neothelium-ft-amnion-graft-diabetic-foot-ulcers

Prospective Case Series Evaluating the Efficacy and Safety of ... This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Diabetic Foot Ulcers.

9. withpower.com withpower.com/trial/phase-foot-ulcer-5-2025-f9f2c

NeoThelium FT for Foot Ulcer The ulcer should be between 0.5cm2 and 25cm2 in size, show less than half healing over the past month, and must not be infected or have visible bone.