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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 Injury

Over 18 Years
+29 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional
Study Start: November 2025

See protocol details

Summary

Principal SponsorNuScience Medical Biologics, LLC
Study ContactAngelina Ferguson, DNP
Last updated: October 29, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: November 13, 2025Actual 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 
Principal SponsorNuScience Medical Biologics, LLC
Study ContactAngelina Ferguson, DNP
Last updated: October 29, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Pressure Injury
Criteria
14 inclusion criteria required to participate
Male or Female, 18 years of age or older
Subject has a medical diagnosis of Pressure Injury/Ulcer located on the pelvis or lower extremity
Subject has a Pressure Injury/Ulcer Stage 2 or 3 without infection
Index ulcer is a minimum of 1cm2 and a maximum of 30cm2 at first treatment visit

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15 exclusion criteria prevent from participating
Subject has a known life expectancy of <1 year
Subject is unable to comply with protocol treatment
Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing in the opinion of the investigator
Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound

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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

Complete wound closure (100% epithelialization without drainage)
Secondary Objectives

Percent area reduction of wounds at 16 weeks compared to initial baseline measurement (performed using standardized methods of wound area measurement)

Evaluate wounds remaining closed for the 2 week follow

Average number of grafts/weeks used to achieve wound closure

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
Suspended
MedCentris of Bossier CityBossier City, United StatesSee the location
Recruiting soonOne Study Center