Donated placenta graft shows promise for chronic wounds
NCT ID NCT07041177
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a wound covering made from donated human placental tissue, called NeoThelium FT, in 10 adults with chronic open wounds that had not healed for at least 4 weeks. The goal was to see if the graft could help close the wound completely. Researchers measured wound closure and how long it stayed closed. Because the study is small and had no control group, the results are preliminary.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NeoThelium FT (a dehydrated wound covering made from donated human placental tissue)
- What this could lead to
- If successful, this could offer a new option to help close chronic open wounds that have not healed with standard care.
- What could go wrong
- This is a very small study with only 10 participants and no comparison group, so results may not apply to everyone. The product is still experimental.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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10 people
The number who actually took part.
- Started
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Aug 2025
- Finished
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Apr 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or Female, 18 years of age or older 2. Subject has a medical diagnosis of "other" Open wound 3. Subject has a chronic open wound present for 4 weeks or greater (documented in medical record) 4. Ulcer area is a minimum of 1 cm2 and a maximum of 25 cm2 at first treatment visit 5. Index wound has a maximum depth of 1cm at the first treatment visit 6. Subject is able and willing to follow the protocol requirements 7. Subject had signed informed consent 8. 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. 9. The chronic open wound is treated with offloading therapy at the Principal Investigator's discretion, if applicable to location, while standing, sitting, and lying down for 7 days prior to the first treatment visit 10. Wound free of clinical infection or clinically visible exposed bone (no purulent discharge, cellulitis, or osteomyelitis) 7 days prior to treatment visit 1 Exclusion Criteria: 1. Subject is unable to comply with protocol treatment 2. Subject with a wound diagnosis of diabetic foot wound, pressure wound, venous leg wound, burn wound, or alternative diagnosis other than "open wound" 3. Presence of systemic infection, sepsis, or osteomyelitis at screening. 4. Multiple wounds at the same site of the referenced wound with \< 2 cm separation from the target ulcer. 5. 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. 6. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound. 7. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator 8. Known contraindications or hypersensitivity to amniotic membrane products or components of NeoThelium FT. 9. Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P interfering with wound treatment and/or healing. 10. Subject is pregnant or breastfeeding 11. 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 12. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to enrollment 13. Index ulcer suspicious of neoplasm in the opinion of the principal investigator 14. Open wound with active infection 15. Wound depth with visible exposed bone 16. Index wound suspicious of neoplasm in the opinion of the principal investigator
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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MedCentris of Hammond
Hammond, Louisiana, 70403, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.