Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Donated placenta graft shows promise for chronic wounds

NCT ID NCT07041177

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

10 people

The number who actually took part.

Started

Aug 2025

Finished

Apr 2026

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Open wound are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • MedCentris of Hammond

    Hammond, Louisiana, 70403, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.