NeoThelium FT for Bed Sores

Overseen By Sarah Moore, MBE

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NuScience Medical Biologics, LLC

Must not be taking: Immunosuppressants, Chemotherapy, Steroids, others

Disqualifiers: Malignancy, Pregnancy, Osteomyelitis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, NeoThelium FT (a topical therapy), to determine its effectiveness in healing bed sores, also known as pressure ulcers. The focus is on sores located on the pelvis or lower body in stages 2 or 3, meaning they are open but not infected. Suitable candidates for this trial have bed sores between 1 cm² and 30 cm² in size, are not infected, and are already using pressure-relieving methods. Participants will receive wound care alongside the new treatment to help manage their condition. As an unphased trial, this study provides a unique opportunity for patients to contribute to understanding the potential benefits of a new treatment.

Do I need to stop my current medications to join the trial?

The trial 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 these before joining. It's best to discuss your specific medications with the trial team.

What prior data suggests that NeoThelium FT is safe for managing chronic pressure ulcers?

Research shows that NeoThelium FT is being tested for safety and effectiveness in treating chronic pressure ulcers, also known as bed sores. Earlier studies have examined its use for similar conditions, such as venous leg ulcers, and found that patients generally tolerate NeoThelium FT well.

These studies have not directly linked any serious side effects to NeoThelium FT. The treatment involves an amnion skin graft, a layer of tissue, to aid in healing the ulcers. Before starting treatment, ulcers must be clean and free of infection and dead tissue to ensure safe use. This careful preparation enhances the safety of NeoThelium FT.

Although information on side effects in humans is limited, current research suggests that NeoThelium FT is safe for managing chronic pressure ulcers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

NeoThelium FT is unique because it combines a comprehensive approach to treating bed sores, addressing multiple aspects of wound care simultaneously. Unlike standard treatments that often focus on just one or two aspects like cleansing or moisture balance, NeoThelium FT integrates wound cleansing, sharps debridement, application of NeoThelium FT, dressing for moisture balance, and offloading. This multi-faceted approach not only aims to enhance healing efficiency but also potentially reduces the time required for recovery, making it a promising option for patients with bed sores. Researchers are excited because this integrated method could significantly improve outcomes compared to the existing standard care practices.

What evidence suggests that NeoThelium FT is effective for bed sores?

Research has shown that NeoThelium FT, a skin graft made from amnion, may help treat chronic pressure ulcers, also known as bed sores. Before using NeoThelium FT, fewer than half of the patients with these sores healed within 30 days, highlighting its potential effectiveness in challenging cases. This trial will evaluate NeoThelium FT alongside standard of care (SOC) treatments, such as wound cleansing, sharps debridement, and moisture-balancing dressings. Studies are examining how NeoThelium FT aids in healing these persistent sores by promoting new skin growth. Although more information is needed, early results are promising regarding its healing ability. ^{1 3 4 6 7}

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 adults with a medically diagnosed pressure ulcer on the pelvis or lower extremity. The ulcer should be between 1cm2 and 30cm2 in size, at Stage 2 or 3 without infection, and free of necrotic debris. Participants must use negative pressure wound therapy (NPWT) and offloading therapy as directed, and have good blood flow to the affected area.

Inclusion Criteria

My wound is less than 1cm deep and I can use a wound vacuum as directed.

My wound is deeper than 1cm2 and I can use a wound vacuum at the required setting.

My wound does not have any dead tissue before treatment.

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 along with standard of care (SOC) for chronic pressure ulcers

16 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for wound closure and safety after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NeoThelium FT

Trial Overview The study tests NeoThelium FT Amnion Skin Graft's effectiveness and safety in treating chronic pressure ulcers. It's a prospective case series where patients receive this treatment under medical supervision to see how well it heals their sores.

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/NCT06918548

Evaluating the Efficacy of NeoThelium FT in the Treatment ... Subject has a Pressure Injury/Ulcer with a historical wound measurement showing less than 50% healing within 30 days prior to randomization; Subject has a ...

2. withpower.com withpower.com/trial/phase-pressure-ulcer-9-2025-dda6c

NeoThelium FT for Bed Sores · Info for Participants NeoThelium FT. Trial Overview The study tests NeoThelium FT Amnion Skin Graft's effectiveness and safety in treating chronic pressure ulcers.

3. patlynk.com patlynk.com/trial/NCT07158658

NeoThelium FT for Chronic Pressure Ulcer Healing This study aims to evaluate the effectiveness of a treatment called NeoThelium FT in healing chronic pressure ulcers.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07061613

Study Details | NCT07061613 | Prospective Case Series ... Study Details | NCT07061613 | Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Venous Leg Ulcers | ClinicalTrials.gov.

5. univerahealthcare.com univerahealthcare.com/documents/d/global/uni-prv-bioengineered-tissue-products-for-wound-treatment-and-surgical-interventions

Bioengineered Tissue Products for Wound Treatment and ... After study inclusion criteria, data were included on the treatment of 226 diabetic foot ulcers from 99 wound care centers. Foot wounds were ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07158658

Prospective Case Series Evaluating the Efficacy and Safety ... Index ulcer is free of infection prior to the first treatment visit and during screening phase. Index ulcer is free of necrotic debris prior to NeoThelium FT ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT07061613/prospective-case-series-evaluating-the-efficacy-and-safety-of-neothelium-ft-for-venous-leg-ulcers?dt_type=updated&state=LA&city=Slidell

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