An interventional study of NeoThelium FT (HCT/P 361) in Venous Leg Ulcer, sponsored by NuScience Medical Biologics, LLC. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by NuScience Medical Biologics, LLC · Not applicable, Interventional, and Treatment
Among 155 studies in Varicose Ulcer with a site in United States — 34 open to participants now, 43 under way, 4 of them phase 3. Varicose Ulcer · United States.
Among the 155 studies in Varicose Ulcer with a site in United States, this one is the 115th largest by enrollment of the 132 interventional ones, is one of 12 that started in 2025, is one of 79 with no phase, and was the 144th registered.
369 studies on the registry are indexed under Varicose Ulcer; 77 are open to participants now.
This study's enrollment of 8 is below the median of 60 across 309 interventional studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →34 of the 155 studies in Varicose Ulcer with a site in United States are open now, in 10 countries. Each count lists the studies.
Of the 52 Varicose Ulcer studies recruiting now, 42 (81%) set no upper age limit and 5 (10%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →155 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 12 started in 2025.
Median enrollment 53 across the 132 interventional studies, 300 across the 23 observational. Of the 87 that completed or were terminated, 34 (39%) have results posted.
109 of 155 have an industry lead sponsor. The 10 most frequent:
NuScience Medical Biologics, LLC is the lead sponsor of 9 studies on the registry; 6 are open to participants now.
NuScience Medical Biologics, LLC has 3 studies filed under Varicose Ulcer — fewer than ten, so there is no comparison to draw.
19 of the studies in Varicose Ulcer with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06568627Phase 3MediWound LtdA Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE) | 2026-12 |
| NCT06707103Phase 3TR TherapeuticsTissue Repair Gel in Venous Leg Ulcers in AU/US | 2026-12 |
| NCT06489028Phase 3RHEACELL GmbH & Co. KGAllogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Therapy-resistant CVU (Phase III) | 2027-04 |
| NCT06674980C5 BiomedicalClinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs | 2026-11-22 |
| NCT06453187Integra LifeSciences CorporationA Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers | 2026-12-31 |
Among the 155 studies in Varicose Ulcer with a site in United States, from their registry updates:
This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Venous Leg Ulcers
This research will take place across multiple medical centers, where both researchers and participants will know which treatment is being used (open label). Patients who agree to participate and meet the study requirements during screening will begin SOC plus NeoThelium FT weekly applications. The subject will continue follow-up per the original schedule. As this is a post-marketing study, it will gather information regarding the efficacy of treatment while also supporting insurance reimbursement decisions.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Wound cleansing, sharps debridement, NeoThelium FT application, Dressing for moisture balance, Offloading
Other: NeoThelium FT (HCT/P 361)
NeoThelium FT is a dehydrated wound covering derived from donated human placental tissue.
Complete Wound Closure
The primary endpoint will be the percentage of target ulcers that achieve complete wound closure.
Time frame: 1-12 weeks
Percentage Wound Area Change
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.
Time frame: 1-12 weeks
Follow-Up Closure
Number of wounds remaining closed during the 2-week follow-up
Time frame: 2 weeks
Time to Closure
Average number of grafts and/or weeks used to achieve wound closure
Time frame: 1-12 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2025 to primary completion in Feb 2026, 5 months.
Of 66 industry-sponsored interventional studies with no phase under Varicose Ulcer, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 37. This study's 5 months is below that.
Counting every sponsor, half of 133 studies reached it within 28 months; a quarter within 13 and three quarters within 48.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 10, 2026: primary completion Jun 2026 → Feb 2026 and completion Jul 2026 → Mar 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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NuScience Medical Biologics, LLC