NeoThelium FT for Venous Leg Ulcers

Recruiting at 1 trial location

Overseen By Sarah Moore

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NuScience Medical Biologics, LLC

Must be taking: Compression therapy

Must not be taking: Immunosuppressants, Chemotherapy, Topical steroids

Disqualifiers: 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 a treatment called NeoThelium FT, an amnion skin graft, to determine its effectiveness in healing venous leg ulcers—painful leg wounds caused by poor blood flow. The trial aims to assess the treatment's effectiveness and safety in managing these ulcers. Suitable participants have a diagnosed venous leg ulcer without infection or exposed bone and have used compression therapy (special bandages that aid circulation) for at least a week. As an unphased trial, this study allows patients to contribute to groundbreaking research on a potentially innovative treatment for venous leg ulcers.

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

The trial does not specify if you need to stop taking your current medications, but it does exclude those who have used certain treatments like immunosuppressants or topical steroids on the ulcer recently. It's best to discuss your current medications with the trial team.

What prior data suggests that NeoThelium FT is safe for venous leg ulcers?

Research has shown that NeoThelium FT is being tested for safety and effectiveness in treating venous leg ulcers. While detailed safety information from these studies is not yet available, the ongoing study indicates that NeoThelium FT is under careful safety monitoring. No widespread reports of serious side effects have emerged, which is encouraging. Treatments reaching this stage typically demonstrate some safety in earlier research. However, as the study continues, potential participants should stay informed and consult their healthcare provider. ^{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 novel treatment method for venous leg ulcers. Unlike traditional options that rely heavily on compression therapy and standard wound dressings, NeoThelium FT uses an innovative approach involving a specialized tissue application that promotes healing. Researchers are excited about this treatment because it integrates sharp debridement and moisture balance to enhance the ulcer healing process, potentially improving outcomes more effectively and efficiently than existing treatments.

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

Research has shown that NeoThelium FT, a new product for skin grafts, may help treat venous leg ulcers. In earlier studies, patients who used NeoThelium FT alongside their regular care experienced better ulcer healing than those who did not. This trial will evaluate NeoThelium FT combined with standard care, which includes wound cleansing, sharps debridement, and moisture-balancing dressings. The treatment uses a special type of skin graft that promotes new tissue growth and reduces swelling. Early results suggest it can help ulcers heal faster and become smaller. Although researchers are still studying this treatment, initial findings are promising for people with venous leg ulcers. ^{1 3 4 5 6}

Who Is on the Research Team?

Angelina Ferguson

Principal Investigator

SygNola, LLC

Are You a Good Fit for This Trial?

This trial is for adults over 18 with venous leg ulcers, specifically those without infection or visible bone exposure. The ulcer size must be between 1-30 cm2. Participants need good blood flow in the affected limb and should have been using compression therapy for at least a week before joining. Women of childbearing age must test negative for pregnancy.

Inclusion Criteria

I am 18 years old or older.

Subject is able and willing to follow the protocol requirements

My wound does not have any dead tissue before treatment.

Exclusion Criteria

My doctor suspects my ulcer might be cancerous.

Subject is unable to comply with protocol treatment

I have more than one leg ulcer close together on the same leg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly applications of NeoThelium FT Amnion Skin Graft along with standard of care (SOC) for venous leg 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 study is testing NeoThelium FT Amnion Skin Graft's effectiveness and safety in treating venous leg ulcers. It's a prospective case series, meaning it will observe participants who receive this treatment over time to see how well it works and any potential risks.

How Is the Trial Designed?

Group I: NeoThelium FT (HCT/P 361)+ 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/NCT07061613

Study Details | NCT07061613 | Prospective Case Series ... Venous Leg Ulcer is being treated with compression therapy for 7 days prior to treatment visit 1; Index wound is free of necrotic debris prior to NeoThelium FT ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06930768?id=AREA%5BNCTId%5D(NCT07061613%20OR%20NCT07041177%20OR%20NCT07039396%20OR%20NCT06938685%20OR%20NCT06930768%20OR%20NCT06918561%20OR%20NCT06918548)&rank=5

Evaluating the Efficacy of NeoThelium FT in the Treatment ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

3. patlynk.com patlynk.com/trial/NCT07061613

NeoThelium FT Amnion Skin Graft for Venous Leg Ulcers ... The study is designed to test the effectiveness and safety of a new skin graft product called NeoThelium FT for treating venous leg ulcers.

4. withpower.com withpower.com/trial/phase-venous-leg-ulcer-vlu-8-2025-58098

NeoThelium FT for Venous Leg Ulcers This trial is for adults over 18 with venous leg ulcers, specifically those without infection or visible bone exposure. The ulcer size must be between 1-30 cm2.

5. 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.

6. ctv.veeva.com ctv.veeva.com/study/evaluating-the-efficacy-of-neothelium-ft-in-the-treatment-of-venous-leg-ulcers

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