Diabetic Foot UlcerNCT07039396
Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers
A study testing NeoThelium FT (HCT/P 361) in people with Diabetic Foot Ulcer, run by NuScience Medical Biologics, LLC at 3 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 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 (HCT/P 361)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Aug 2025to 1 Jun 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 with a diabetic foot ulcer
- 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.
- Ulcer area is a minimum of 0.5 cm2 and a maximum of 25 cm2 at first treatment visit
- Subject is able and willing to follow the protocol requirements
- Subject had signed informed consent
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- Adequate circulation if wound is location on the lower extremity demonstrated by an ABI of >0.7 and <1.3, or TBI of >0.6 within 30 days prior to informed consent OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to the first treatment visit.
- Diabetic foot ulcer is being treated with TCC offloading therapy OR Fixed Ankle Walker if approved by Medical Monitor for 7 days prior to treatment visit 1
- Wound free of clinical infection (no purulent discharge, cellulitis, or osteomyelitis) post-debridement.
- Record of serum hemoglobin A1c within 90 days prior to the first treatment visit
Who cannot join
- Subject is unable to comply with protocol treatment
- Target ulcer is a Wagner 3 of acute osteomyelitis that has not been successfully treated with 6 weeks of IV antibiotics or is diagnosed as chronic refractory osteomyelitis.
- Wagner 3, 4, or 5 involving tendon, bone, or joint.
- Presence of systemic infection, sepsis, or osteomyelitis at screening.
- Multiple DFUs on the same foot with < 2 cm separation from the target ulcer.
- 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.
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- 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 or hypersensitivity to amniotic membrane products or components of NeoThelium FT.
- Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P 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 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 enrollment
- Index ulcer suspicious of neoplasm in the opinion of the principal investigator
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
MedCentris of Alexandria
Alexandria, Louisiana, 71301
Laura Whittington, LPN, 318-545-0655, Laura.whittington@medcentris.com
Rachel Ward, FNP
- Recruiting
MedCentris of Leesville
Leesville, Louisiana, 71446
Brandi Shuff, LPN, 337-282-1091, Brandi.shuff@medcentris.com
Stefanie Corley, FNP
- Recruiting
MedCentris of Many
Many, Louisiana, 71449
Brandi Shuff, LPN, 337-282-1091, Brandi.shuff@medcentris.com
Stefanie Corley, FNP
About this study
Official title: Evaluating the Efficacy and Safety of NeoThelium FT Amnion Skin Graft in the Management of Diabetic Foot 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 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 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
- Diabetic Foot Ulcer
- Being tested
- NeoThelium FT (HCT/P 361)
- Keywords
- Chronic Wounds, 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.
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
The primary endpoint will be the percentage of target ulcers that achieve complete wound closure by manual measurement utilizing a ruler.
Measured: 1-12 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 standardized method of wound area measurement and physical examination.
Measured: 1-12 weeks
Follow-Up Closure
Number of wounds remaining closed during the 2-week follow-up
Measured: 2 weeks
Time to Closure
Average number of grafts/weeks used to achieve wound closure
Measured: 1-12 weeks
Hemoglobin A1c
Average Sample of HbA1c
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start26 Aug 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 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
- 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
- NCT07039396
- Sponsor's protocol ID
- NeoDia
- Status last verified
- Mar 2026
- First submitted
- 18 Jun 2025
- Last updated
- 12 Mar 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 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Safety of NeoThelium FT Amnion Skin Graft in the Management of Diabetic Foot Ulcers: A Prospective Case Series
- ClinicalTrials.gov ID
- NCT07039396
- Acronym / sponsor ID
- NeoDia
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Chronic Wounds, 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
- 10 participants (estimated)
- Lead sponsor
- NuScience Medical Biologics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- SygNola, LLC
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 26 Jun 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 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 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 (10 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 with a diabetic foot ulcer
- 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.
- Ulcer area is a minimum of 0.5 cm2 and a maximum of 25 cm2 at first treatment visit
- Subject is able and willing to follow the protocol requirements
Key exclusion criteria (14 listed)
- Subject is unable to comply with protocol treatment
- Target ulcer is a Wagner 3 of acute osteomyelitis that has not been successfully treated with 6 weeks of IV antibiotics or is diagnosed as chronic refractory osteomyelitis.
- Wagner 3, 4, or 5 involving tendon, bone, or joint.
- Presence of systemic infection, sepsis, or osteomyelitis at screening.
- Multiple DFUs on the same foot with < 2 cm separation from the target ulcer.
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: 1-12 weeks
The primary endpoint will be the percentage of target ulcers that achieve complete wound closure by manual measurement utilizing a ruler.
4 secondary outcomes
Percentage Wound Area Change
Time frame: 1-12 weeks
Follow-Up Closure
Time frame: 2 weeks
Time to Closure
Time frame: 1-12 weeks
Hemoglobin A1c
Time frame: 1 week
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 12 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot Ulcer
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PAW-Hydrogel for Chronic Wound Healing
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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
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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.
Angelina Ferguson, DNP study chair
SygNola, LLC
3 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 Diabetic Foot Ulcer, run by NuScience Medical Biologics, LLC at 3 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 10 inclusion and 14 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 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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, 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 12 Mar 2026.