Recruiting

NeoThelium FT for Chronic Pressure Ulcer Healing

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What is being tested

NeoThelium FT (HCT/P 361)

Other
Who is being recruted

Pressure Ulcer+1

+ Skin Diseases

+ Skin Ulcer

Over 18 Years
+29 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: December 2025
See protocol details

Summary

Principal SponsorNuScience Medical Biologics, LLC
Study ContactAngelina Ferguson, DNPMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2025

Actual date on which the first participant was enrolled.

This study aims to evaluate the effectiveness of a treatment called NeoThelium FT in healing chronic pressure ulcers. Chronic pressure ulcers, often known as bedsores, are a common issue for individuals who are immobile or have limited mobility, causing pain and discomfort. The study is important as it seeks to find better ways to heal these persistent wounds, which can significantly improve quality of life for those affected. The information gathered may also help make decisions related to insurance coverage for the treatment. Participants will receive weekly applications of NeoThelium FT alongside standard care procedures. This study is "open label," meaning both the medical staff and participants know exactly what treatment is being applied. The main focus is on gathering data about how well the treatment works when combined with usual care methods. This information can help guide future treatment recommendations and insurance policies related to pressure ulcer management.

Official TitleEvaluation of the Efficacy of NeoThelium FT in the Healing of Chronic Pressure Ulcers: A Prospective Case Series 
NCT07158658
Principal SponsorNuScience Medical Biologics, LLC
Study ContactAngelina Ferguson, DNPMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Pressure UlcerSkin DiseasesSkin UlcerSkin and Connective Tissue Diseases

Criteria

14 inclusion criteria required to participate
Male or Female, 18 years of age or older
Index ulcer is free of necrotic debris prior to NeoThelium FT application
Index ulcer is free of infection prior to the first treatment visit and during screening phase.
Index ulcer has a depth of > 1cm2, and subject is compliant to use continuous NPWT with 75-100mmHg
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15 exclusion criteria prevent from participating
Pressure Injury/Ulcer of Stage 4 or active osteomyelitis
Subject with history of immunosuppressant treatment (systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the ulcer surface for >14 days duration within 30 days prior to the first treatment visit; or anticipated use of the above during the course of the study
Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to the first treatment visit
Subject has a known life expectancy of <1 year
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

MedCentris of Bossier City

Bossier City, United StatesSee the location
Recruiting
One Study Center