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, 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 
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 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 Ulcer
Skin Diseases
Skin Ulcer
Skin 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

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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

NeoThelium FT (HCT/P 361) is a dehydrated wound covering derived from donated human placental tissue. NeoThelium FT is a dual-layer membrane with amnion and chorion combination layers.
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
Recruiting
MedCentris of Bossier CityBossier City, United StatesSee the location
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One Study Center