Pressure InjuryNCT06918548
Evaluating the Efficacy of NeoThelium FT in the Treatment of Pressure Injuries
A study testing NeoThelium FT in people with Pressure Injury, run by NuScience Medical Biologics, LLC.
Trial summary
This is a randomized controlled trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating pressure injuries. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 May 2028
- 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 present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC
- Subject has a Pressure Injury/Ulcer with a historical wound measurement showing less than 50% healing within 30 days prior to randomization
- Subject has a Pressure Injury/Ulcer with screening wound measurement showing less than 25% healing within 14 days prior to randomization
- Subject has a Pressure Injury/Ulcer Stage 2, 3, and 4 without infection or clinically visible exposed bone
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- Index ulcer is a minimum of 1cm2 and a maximum of 25cm2 at first treatment visit
- Index ulcer has a maximum depth of 1cm at first screening visit
- Pressure Injury/Ulcer is treated with offloading therapy while standing, sitting and lying down (if applicable to wound location) for 14 days prior to randomization
- Adequate circulation of ulcer demonstrated by an ABI of >0.7 and <1.3, or TBI of >0.6 within 30 days prior to randomization
- Index ulcer is free of infection prior to randomization and during screening phase.
- Index ulcer is free of necrotic debris prior to [insert product/device] application
- Female subjects of childbearing potential having a negative pregnancy test prior to randomization
- Index ulcer is free of infection prior to randomization and during screening phase noted with the NERDS Assessment. Infection must be adequately treated and controlled prior to randomization.
- Having a Mini Nutritional Assessment Score of 12 or higher indicated a normal nutritional status
- 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 1 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
- 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
- Wound reduces in area by ≥25% after 14 days of SOC prior to randomization
- 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 >2 weeks duration within 30 days prior to randomization; 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 randomization
- Pressure Injury/Ulcer of Stage 4 grade with active osteomyelitis or exposed visible bone
- Wound depth with visible exposed bone
- HBOT within 14 days prior to randomization
- Revascularization surgery on the index ulcer leg within 30 days of screening phase
- Index ulcer suspicious of neoplasm in the opinion of the principal investigator
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Efficacy of NeoThelium FT in the Healing of Chronic Pressure Ulcers: A Randomized Controlled Multicenter Trial
This is a randomized controlled trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating pressure injuries.
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 be randomly assigned to one of two groups: either standard of care alone, or standard of care plus NeoThelium FT. As this is a post-marketing study, it will gather information about how effective the treatment is in treating pressure injuries. All subjects will complete two week screening phase prior to being randomized into a treatment arm. Treatment arms will consist of NeoThelium FT in conjunction with standard of care, vs. standard of care alone. The primary endpoint will be the percentage of target ulcers that achieve complete wound closure within 16 weeks. Secondary endpoints consist of wound area reduction rates, time to closure, follow-up closure, and pain assessment.
- Conditions
- Pressure Injury
- Being tested
- Standard of Care, NeoThelium FT
- Keywords
- Chronic wounds, Wound Medicine, Cellular, Acellular, Matrix-like Product (CAMP), Cellular and/or Tissue Product (CTP), Dehydrated Complete Human Placental Membrane (dCHPM)
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
Wound cleansing, Sharps debridement, Dressing for moisture balance, Offloading
NeoThelium FTOther
NeoThelium FT 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 |
|---|---|---|
| No Intervention: Standard of Care | Active comparator | Wound cleansing, Sharps debridement, Dressing for moisture balance, Offloading Receives: Other: Standard of Care |
| Intervention: NeoThelium FT & Standard of Care | Experimental | Wound cleansing, sharps debridement, NeoThelium FT application, Dressing for moisture balance, Offloading Receives: Other: NeoThelium FT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Wound Closure
The primary endpoint will be the percentage of target ulcers that achieve complete wound closure.
Measured: 1-16 weeks
Secondary outcomes (4)
Percentage Wound Area Change
The percentage change in wound area from TV-1 to TV-13 will be measured weekly using digital photographic planimetry and physical examination.
Measured: 1-16 weeks
Time to Closure
Average number of grafts and/or weeks used to achieve wound closure
Measured: 1-16 weeks
Follow-Up Closure
Number of wounds remaining closed during the 2-week follow-up
Measured: 2 weeks
Pain Assessment
Change in pain associated with the target ulcer will be assessed using the Numeric Pain Rating Scale at designated time points
Measured: Day 0, Day 14, Day 35, Day 56, Day 77, Day 98, Day 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Jul 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 May 2028 (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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The subject will be randomized to one of the following treatments: * Standard of care * NeoThelium FT in addition to standard of care
- Masking
- None (open label)
- Enrolment
- 148 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 director, SygNola, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918548
- Sponsor's protocol ID
- PROTECT
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2025
- Last updated
- 7 Apr 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 7 Apr 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 Randomized Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT06918548
- Acronym / sponsor ID
- PROTECT
- Conditions
- Pressure Injury
- Keywords
- Chronic wounds, Wound Medicine, Cellular, Acellular, Matrix-like Product (CAMP), Cellular and/or Tissue Product (CTP), Dehydrated Complete Human Placental Membrane (dCHPM)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- NuScience Medical Biologics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- SygNola, LLC
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 9 Apr 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 randomized controlled trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating pressure injuries.
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 be randomly assigned to one of two groups: either standard of care alone, or standard of care plus NeoThelium FT. As this is a post-marketing study, it will gather information about how effective the treatment is in treating pressure injuries. All subjects will complete two week screening phase prior to being randomized into a treatment arm. Treatment arms will consist of NeoThelium FT in conjunction with standard of care, vs. standard of care alone. The primary endpoint will be the percentage of target ulcers that achieve complete wound closure within 16 weeks. Secondary endpoints consist of wound area reduction rates, time to closure, follow-up closure, and pain assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The subject will be randomized to one of the following treatments: * Standard of care * NeoThelium FT in addition to standard of care
| Arm | Type | Receives |
|---|---|---|
| No Intervention: Standard of Care | Active comparator | Other: Standard of CareWound cleansing, Sharps debridement, Dressing for moisture balance, Offloading |
| Intervention: NeoThelium FT & Standard of Care | Experimental | Other: NeoThelium FTWound 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 (18 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 present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC
- Subject has a Pressure Injury/Ulcer with a historical wound measurement showing less than 50% healing within 30 days prior to randomization
- Subject has a Pressure Injury/Ulcer with screening wound measurement showing less than 25% healing within 14 days prior to randomization
Key exclusion criteria (16 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
- 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 |
|---|---|---|
| Standard of CareWound cleansing, Sharps debridement, Dressing for moisture balance, Offloading | Other | No Intervention: Standard of Care |
| NeoThelium FTNeoThelium FT 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 | Intervention: NeoThelium FT & Standard of Care |
Primary outcome
Complete Wound Closure
Time frame: 1-16 weeks
The primary endpoint will be the percentage of target ulcers that achieve complete wound closure.
4 secondary outcomes
Percentage Wound Area Change
Time frame: 1-16 weeks
Time to Closure
Time frame: 1-16 weeks
Follow-Up Closure
Time frame: 2 weeks
Pain Assessment
Time frame: Day 0, Day 14, Day 35, Day 56, Day 77, Day 98, Day 112
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 7 Apr 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 director
SygNola, LLC
Questions about this trial
What is this clinical trial studying?
A study testing NeoThelium FT in people with Pressure Injury, run by NuScience Medical Biologics, LLC.
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 18 inclusion and 16 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: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 ((985) 629-4013, info@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 7 Apr 2026.