Diabetic Foot UlcerNCT06938685
Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers
A study testing NeoThelium FT in people with Diabetic Foot Ulcer, run by NuScience Medical Biologics, LLC at 8 sites in United States.
Trial summary
This is a randomized controlled crossover trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- NeoThelium FT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 8 sitesUnited States
- Study dates
- 6 Oct 2025to 1 Oct 2026
- 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 Type I or Type II Diabetes Mellitus requiring oral or glycemic control and/or insulin replacement therapy
- Subject has a diabetic foot 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 diabetic foot ulcer with a historical wound measurement showing less than 25% healing in 14 days prior to screening
- Subject has a diabetic foot ulcer with screening wound measurement showing less than 25% healing in 14 days prior to randomization
- Subject has a diabetic foot ulcer of Wagner grade 1, 2, or 3 without infection or clinically visible exposed bone. Wagner 3 is acceptable if the diagnosis is acute osteomyelitis and the subject has successfully completed IV antibiotic treatment prior to screening.
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- Index ulcer is a minimum of 0.5cm2 and a maximum of 25cm2 at first treatment visit
- Diabetic foot ulcer is being treated with offloading therapy 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 OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to randomization.
- Index ulcer is free of infection prior to randomization and during screening phase. Infection must be adequately treated and controlled as defined by Infectious Disease Society of America (IDSA) Guidelines PEDIS Grade 1.
- Index ulcer is free of necrotic debris prior to NeoThelium FT application
- Female subjects of childbearing potential having a negative pregnancy test prior to randomization
- 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 expectance 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 device 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 >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
- Diabetic foot ulcer of Wagner 3 grade with active acute infection that has not completed IV antibiotic treatment, or Wagner 3 grade with chronic refractory osteomyelitis
- 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
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 4 recruiting
- Recruiting
MedCentris of Alexandria
Alexandria, Louisiana, 71301
Laura Whittington, LPN, Laura.whittington@medcentris.com
Rachel Ward, FNP
- Completed
Pace Foot and Ankle Center
Bryn Mawr, Pennsylvania, 19010
- Completed
MedCentris of Franklinton
Franklinton, Louisiana, 70438
- Recruiting
MedCentris of Hammond
Hammond, Louisiana, 70403
Chelsea Smith, Chelsea.smith@medcentris.com
Amber Landry, NP
- Recruiting
MedCentris of Minden
Minden, Louisiana, 71055
Brianna Thompson, brianna.thompson@medcentris.com
Taheera Forbes, NP
- Completed
MedCentris of Monroe
Monroe, Louisiana, 71201
- Completed
MedCentris of Natchez
Natchez, Mississippi, 39120
- Recruiting
MedCentris of Picayune
Picayune, Mississippi, 39466
Emily Adams, LPN, Emily.adams@medcentris.com
Gavin Mayo, FNP
About this study
Official title: Evaluation of the Efficacy of NeoThelium FT in the Healing of Chronic Diabetic Foot Ulcers: A Randomized Controlled Multicenter Crossover Trial
This is a randomized controlled crossover trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating diabetic foot 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 be randomly assigned to one of two groups: either standard of care (SOC) alone, or SOC plus NeoThelium FT.
The study includes a crossover component for subjects in the SOC arm. At treatment visit 13 (approximately 84 days post-randomization), SOC arm subjects not having achieved complete wound closure, and still meeting the inclusion/exclusion criteria, are eligible to cross over to the IP arm (SOC plus NeoThelium FT). Crossover subjects will begin IP arm treatment with weekly NeoThelium FT applications for up to 12 treatment visits. 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. All subjects will complete a 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 12 weeks. Secondary endpoints consist of wound area reduction rates, time to closure, follow-up closure, and pain assessment.
- Conditions
- Diabetic Foot Ulcer
- 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
- Diabetic Foot
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: 1-12 weeks
Secondary outcomes (2)
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: 1-12 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 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start6 Oct 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies 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
- Crossover
- 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
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NuScience Medical Biologics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SygNola, LLC
- Responsible party
- Sponsor
- Investigators
- Desmond Bell, DPM, Study chair, SygNola, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938685
- Sponsor's protocol ID
- OMNEO
- Status last verified
- Jun 2026
- First submitted
- 31 Mar 2025
- Last updated
- 17 Jun 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 17 Jun 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 Diabetic Foot Ulcers: A Randomized Controlled Multicenter Crossover Trial
- ClinicalTrials.gov ID
- NCT06938685
- Acronym / sponsor ID
- OMNEO
- Conditions
- Diabetic Foot Ulcer
- 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
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- NuScience Medical Biologics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- SygNola, LLC
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 22 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 crossover trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating diabetic foot 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 be randomly assigned to one of two groups: either standard of care (SOC) alone, or SOC plus NeoThelium FT.
The study includes a crossover component for subjects in the SOC arm. At treatment visit 13 (approximately 84 days post-randomization), SOC arm subjects not having achieved complete wound closure, and still meeting the inclusion/exclusion criteria, are eligible to cross over to the IP arm (SOC plus NeoThelium FT). Crossover subjects will begin IP arm treatment with weekly NeoThelium FT applications for up to 12 treatment visits. 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. All subjects will complete a 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 12 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
- Crossover
- 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 (15 listed)
- Male or Female, 18 years of age or older
- Subject has a medical diagnosis of Type I or Type II Diabetes Mellitus requiring oral or glycemic control and/or insulin replacement therapy
- Subject has a diabetic foot 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 diabetic foot ulcer with a historical wound measurement showing less than 25% healing in 14 days prior to screening
- Subject has a diabetic foot ulcer with screening wound measurement showing less than 25% healing in 14 days prior to randomization
Key exclusion criteria (15 listed)
- Subject has a known life expectance 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: 1-12 weeks
The primary endpoint will be the percentage of target ulcers that achieve complete wound closure.
2 secondary outcomes
Percentage Wound Area Change
Time frame: 1-12 weeks
Pain Assessment
Time frame: Day 0, Day 14, Day 35, Day 56, Day 84
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 17 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot Ulcer
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
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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.
Desmond Bell, DPM study chair
SygNola, LLC
8 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 in people with Diabetic Foot Ulcer, run by NuScience Medical Biologics, LLC at 8 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 15 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 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 ((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: 1-12 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 17 Jun 2026.