NeoThelium FT for Open Wound

Recruiting at 1 trial location

Overseen By Sarah Moore, MBE

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NuScience Medical Biologics, LLC

Must not be taking: Immunosuppressants, Chemotherapy, Topical steroids, others

Disqualifiers: Diabetic foot wound, 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

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called NeoThelium FT, a topical therapy, to determine if it heals chronic open wounds more effectively than standard care alone. Participants will receive either NeoThelium FT with standard care or standard care alone to compare outcomes. It suits individuals with a chronic open wound lasting at least four weeks, showing limited healing, and without signs of infection or exposed bone. As an unphased trial, this study provides an opportunity to contribute to medical research and potentially benefit from a new treatment option.

Will I have to stop taking my current medications?

The trial 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.

Is there any evidence suggesting that NeoThelium FT is safe for treating chronic open wounds?

Research has shown that NeoThelium FT has been tested in earlier studies to assess its safety and efficacy. In one study, no serious side effects occurred, indicating the treatment is generally safe for patients. Participants in these studies did not experience major side effects, which suggests a favorable safety profile. However, as with any treatment, individual experiences can vary, so discussing potential risks with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

NeoThelium FT is unique because it integrates directly with the wound healing process, potentially accelerating recovery. Unlike other treatments that mainly focus on cleansing and moisture balance, NeoThelium FT combines these with a novel application technique that enhances cell regeneration and tissue repair. Researchers are excited about this treatment because it offers a promising new approach to effectively manage open wounds, potentially reducing healing time and improving patient comfort.

What evidence suggests that NeoThelium FT might be an effective treatment for chronic open wounds?

Research has shown that NeoThelium FT, which participants in this trial may receive, may help heal chronic open wounds. In earlier studies, patients with wounds that healed less than 25% in two weeks received treatment with NeoThelium FT and saw noticeable improvements in healing. Additionally, a series of cases found that using NeoThelium FT as a type of skin graft was both effective and safe for treating open wounds. These findings suggest that NeoThelium FT could be a promising option for those dealing with stubborn wounds. ^{1 3 5 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 individuals with chronic open wounds that have persisted for at least 4 weeks but less than a year, showing little to no healing. The wound should be between 0.5cm² and 25cm² in size, not deeper than 1cm, without infection or visible bone exposure. Participants must have adequate blood flow to the wound area.

Inclusion Criteria

I have an open wound.

I have an open wound for more than 4 weeks but less than 12 months.

My open wound has not healed more than 50% in the last 30 days.

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 safety and effectiveness after treatment

2 weeks

Follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• NeoThelium FT

Trial Overview The study is testing NeoThelium FT combined with standard care against standard care alone to see which is more effective in treating chronic open wounds. It's a randomized controlled crossover trial, meaning participants will receive both treatments in sequence over different periods.

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

Collaborator

SygNola, LLC

Industry Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06918561

Evaluating the Efficacy of NeoThelium FT in the Treatment ... Subject has a chronic open wound with a historical wound measurement showing less than 25% healing within 14 days prior to screening; Subject has a chronic open ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06918548

Evaluating the Efficacy of NeoThelium FT in the Treatment ... Subject has a Pressure Injury/Ulcer with screening wound measurement showing less than 25% healing within 14 days prior to randomization. Subject has a ...

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 ... Subject has a chronic open wound with a historical wound measurement showing less than 25% healing within 14 days prior to screening; Subject ...

4. trial.medpath.com trial.medpath.com/clinical-trial/bb47683588d9c8c0/nct07041177-neothelium-ft-amnion-graft-chronic-wounds

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 Open Wounds.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06918561/evaluating-the-efficacy-of-neothelium-ft-in-the-treatment-of-chronic-open-wounds?dt_type=updated&state=LA&city=Slidell

Evaluating the Efficacy of NeoThelium FT in the Treatment ... Subject has a chronic open wound with a historical wound measurement showing lessthan 25% healing within 14 days prior to screening. Subject has ...

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

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

7. withpower.com withpower.com/trial/phase-open-wound-7-2025-cafcd

NeoThelium FT for Open Wound Trial Overview The trial is testing NeoThelium FT Amnion Skin Graft's effectiveness and safety in treating open wounds. Participants will receive this grafting ...