Recruiting

NeoThelium FT Amnion Skin Graft for Venous Leg Ulcers Treatment

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Study AimThis study is testing whether a NeoThelium FT Amnion skin graft can effectively treat venous leg ulcers by promoting complete wound closure.
What is being tested

NeoThelium FT (HCT/P 361)

Other
Who is being recruted

Venous Leg Ulcer

Over 18 Years
+24 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional
Study Start: September 2025

See protocol details

Summary

Principal SponsorNuScience Medical Biologics, LLC
Study ContactAngelina Ferguson, DNP
Last updated: October 28, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 2, 2025Actual date on which the first participant was enrolled.

The study is designed to test the effectiveness and safety of a new skin graft product called NeoThelium FT for treating venous leg ulcers. Venous leg ulcers are open sores on the leg caused by poor blood flow, and they can be difficult to heal. This research is important as it aims to improve healing outcomes for patients with these ulcers, potentially making treatment more effective and helping insurance companies decide on coverage. The study takes place in several medical centers and involves participants who have agreed to join and meet specific criteria. Participants in the study will receive their standard care plus weekly applications of the NeoThelium FT skin graft. Both the researchers and the participants know which treatment is given, which is known as an open label study. The participants will follow a schedule for check-ups to monitor their progress. The study aims to collect data on how well the treatment works and if it helps with insurance reimbursement decisions. This information could lead to better treatment strategies for those suffering from venous leg ulcers.

Official TitleEvaluating the Efficacy and Safety of NeoThelium FT Amnion Skin Graft in the Management of Venous Leg Ulcers: A Prospective Case Series 
Principal SponsorNuScience Medical Biologics, LLC
Study ContactAngelina Ferguson, DNP
Last updated: October 28, 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
Venous Leg Ulcer
Criteria
12 inclusion criteria required to participate
Male or Female, 18 years of age or older
Subject has a medical diagnosis of venous leg ulcer or venous insufficiency with a lower extremity wound
Subject has an venous leg ulcer without infection or clinically visible exposed bone
Index wound is a minimum of 1 cm2 and a maximum of 30 cm2 at first treatment visit

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12 exclusion criteria prevent from participating
Subject is unable to comply with protocol treatment
Presence of infection prior to screening
Multiple VLUs on the same leg with < 2 cm separation from the target ulcer
Subject has comorbid conditions that may compromise subject safety or wound healing in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders

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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

The primary endpoint will be the percentage of target ulcers that achieve complete wound closure.
Secondary Objectives

The percentage change in wound area from TV-1 to TV-13 will be measured weekly using manual measurement utilizing a ruler and physical examination.

Number of wounds remaining closed during the 2-week follow-up

Average number of grafts and/or 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 2 locations
Recruiting
MedCentris of MetairieMetairie, United StatesSee the location
Recruiting
MedCentris of SlidellSlidell, United States
Recruiting
2 Study Centers