Pressure InjuryNCT07158658
Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Chronic Pressure Ulcers
A study testing NeoThelium FT (HCT/P 361) in people with Pressure Injury, run by NuScience Medical Biologics, LLC at 2 sites in United States.
Trial summary
This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Chronic Pressure Ulcers Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Injury
- What is being tested?
- NeoThelium FT (HCT/P 361)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Index ulcer has a depth of ≤ 1cm2, and subject is compliant to use continuous NPWT with 75-100mmHg, at the providers discretion
- Index ulcer has a depth of > 1cm2, and subject is compliant to use continuous NPWT with 75-100mmHg
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- Pressure Injury/Ulcer is treated with offloading therapy while standing, sitting and lying down (if applicable to wound location) for 7 days prior to the first treatment visit
- Adequate circulation of ulcer, if located on the lower extremity, demonstrated by an ABI of >0.7 and <1.3, or TBI of >0.6 within 30 days prior to the first treatment visit
- Index ulcer is free of infection prior to the first treatment visit and during screening phase.
- Index ulcer is free of necrotic debris prior to NeoThelium FT application
- Female subjects of childbearing potential having a negative pregnancy test prior to the first treatment visit
- Subject is able and willing to follow the protocol requirements
- Subject had signed informed consent
- If 2 or more ulcers are present, the ulcers must be separated by at least 2 cm
Who cannot join
- 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
- Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
- Known contraindications to tissue-engineered allograft
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- Concurrent participation in alternative clinical trial that involves investigational drug or product interfering with wound treatment and/or healing
- Subject is pregnant or breastfeeding
- 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
- Pressure Injury/Ulcer of Stage 4 or active osteomyelitis
- Wound depth with visible exposed bone
- HBOT within 14 days prior to the first treatment visit
- Revascularization surgery on the index ulcer leg within 30 days of screening phase
- Index ulcer suspicious of neoplasm in the opinion of the investigator
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
MedCentris of Bossier City
Bossier City, Louisiana, 71111
Susan Law Law, LPN, 318-409-0119, susan.law@medcentris.com
Kendra Halsell, FNP
- Not yet recruiting
MedCentris of Rayville
Rayville, Louisiana, 71269
Kimberly Lambert, kimberly.lambert@medcentris.com
Reagan Savage, NP
About this study
Official title: Evaluation of the Efficacy of NeoThelium FT in the Healing of Chronic Pressure Ulcers: A Prospective Case Series
This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Chronic Pressure Ulcers
Read the detailed description
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.
- Conditions
- Pressure Injury
- Being tested
- NeoThelium FT (HCT/P 361)
- Keywords
- Chronic Wounds, Wound Medicine, Cellular and/or Tissue Product (CTP), Dehydrated Complete Human Placental Membrane (dCHPM), Cellular, Acellular, Matrix-like Product (CAMP)
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoThelium FT (HCT/P 361)Other
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 group | Role | What they receive |
|---|---|---|
| NeoThelium FT + SOC | Experimental | Wound cleansing, sharps debridement, NeoThelium FT application, Dressing for moisture balance, Offloading Receives: Other: NeoThelium FT (HCT/P 361) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Wound Closure
Complete wound closure (100% epithelialization without drainage)
Measured: 1-16 weeks
Secondary outcomes (3)
Percent Area Reduction
Percent area reduction of wounds at 16 weeks compared to initial baseline measurement (performed using standardized methods of wound area measurement)
Measured: 1-16 weeks
Wound Closure
Evaluate wounds remaining closed for the 2 week follow
Measured: 2 weeks
Number of Grafts
Average number of grafts/weeks used to achieve wound closure
Measured: 1-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- NeoThelium FT in addition to Standard of Care
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NuScience Medical Biologics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SygNola, LLC
- Responsible party
- Sponsor
- Investigators
- Angelina Ferguson, DNP, Study chair, SygNola, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158658
- Sponsor's protocol ID
- NeoPress
- Status last verified
- May 2026
- First submitted
- 25 Aug 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of NeoThelium FT in the Healing of Chronic Pressure Ulcers: A Prospective Case Series
- ClinicalTrials.gov ID
- NCT07158658
- Acronym / sponsor ID
- NeoPress
- Conditions
- Pressure Injury
- Keywords
- Chronic Wounds, Wound Medicine, Cellular and/or Tissue Product (CTP), Dehydrated Complete Human Placental Membrane (dCHPM), Cellular, Acellular, Matrix-like Product (CAMP)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- NuScience Medical Biologics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- SygNola, LLC
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Chronic Pressure Ulcers
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- NeoThelium FT in addition to Standard of Care
| Arm | Type | Receives |
|---|---|---|
| NeoThelium FT + SOC | Experimental | Other: NeoThelium FT (HCT/P 361)Wound cleansing, sharps debridement, NeoThelium FT application, Dressing for moisture balance, Offloading |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
- Index ulcer has a depth of ≤ 1cm2, and subject is compliant to use continuous NPWT with 75-100mmHg, at the providers discretion
Key exclusion criteria (15 listed)
- 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
- Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeoThelium FT (HCT/P 361)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. | Other | NeoThelium FT + SOC |
Primary outcome
Complete Wound Closure
Time frame: 1-16 weeks
Complete wound closure (100% epithelialization without drainage)
3 secondary outcomes
Percent Area Reduction
Time frame: 1-16 weeks
Wound Closure
Time frame: 2 weeks
Number of Grafts
Time frame: 1-12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angelina Ferguson, DNP study chair
SygNola, LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeoThelium FT (HCT/P 361) in people with Pressure Injury, run by NuScience Medical Biologics, LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angelina Ferguson, DNP (986-629-4013, dr.aferguson@sygnola.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Wound Closure (time frame: 1-16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.