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NeoThelium FT plus standard care for chronic open wounds

A Randomized Controlled Multisite Crossover Trial Evaluating the Efficacy of NeoThelium FT in the Treatment of "Other" Open Wounds

Not applicable Interventional NuScience Medical Biologics, LLC · NCT06918561

This study tests whether adding NeoThelium FT to standard wound care helps adults with chronic open wounds heal faster than standard care alone.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment132 (estimated)
Ages18 Years and up
SexAll
SponsorNuScience Medical Biologics, LLC Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations14 sites (Denham Springs, Louisiana and 13 other locations)
Trial IDNCT06918561 on ClinicalTrials.gov

What this trial studies

This is a randomized, open-label, multicenter crossover trial comparing standard of care (SOC) alone to SOC plus NeoThelium FT in adults with chronic open wounds. Participants are randomized after a two-week screening period and those in the SOC arm who have not achieved closure by about 84 days may cross over to receive weekly NeoThelium FT applications for up to 12 treatment visits. The primary outcome is the percentage of target ulcers achieving complete wound closure within 12 weeks, and secondary outcomes include wound area reduction rates and pain assessment. As a post-marketing study, the trial also aims to collect data to support insurance reimbursement decisions.

Who should consider this trial

Good fit: Adults (18+) with a chronic open wound present at least 4 weeks but less than 12 months, with <25% healing in the prior 14 days, wound size 0.5–25 cm2, depth ≤1 cm, no infection or exposed bone, adequate circulation, and appropriate offloading if applicable.

Not a fit: Patients with active wound infection, clinically exposed bone, wounds outside the size or depth limits, poor circulation or vascular insufficiency, or those who are medically ineligible may not benefit from this intervention.

Why it matters

Potential benefit: If successful, NeoThelium FT could increase the proportion of chronic open wounds that close within 12 weeks, potentially speeding healing and reducing pain and need for further interventions.

How similar studies have performed: Other placental membrane and cellular/tissue-based products (dCHPM/CAMP/CTP) have shown mixed but generally promising results in improving healing of chronic wounds, so this approach is not entirely novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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), and less than 12 months duration if being treated with continuous SOC
4. Subject has a chronic open wound with a historical wound measurement showing less than 25% healing within 14 days prior to screening
5. Subject has a chronic open wound with screening wound measurement showing less than 25% healing within 14 days prior to randomization
6. Subject has an Open wound without infection or clinically visible exposed bone
7. Index wound is a minimum of 0.5cm2 and a maximum of 25cm2 at first treatment visit
8. Index ulcer has a maximum depth of 1cm at screening visit 1
9. The chronic open wound is treated with offloading therapy, if applicable to location, while standing, sitting, and lying down for 14 days prior to randomization
10. Adequate circulation of wounds located below the knee 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.
11. Index ulcer is free of infection prior to randomization and during screening phase.
12. Index ulcer is free of necrotic debris prior to NeoThelium FT application
13. Female subjects of childbearing potential having a negative pregnancy test prior to randomization
14. 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.
15. Subject is able and willing to follow the protocol requirements
16. Subject had signed informed consent
17. If 2 or more ulcers are present, the ulcers must be separated by at least 2 cm

Exclusion Criteria:

1. Subject with a wound diagnosis of diabetic foot wound, pressure wound, venous leg wound, burn wound, or alternative diagnosis other than "open wound"
2. Subject has a known life expectancy of \<1 year
3. Subject is unable to comply with protocol treatment
4. 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.
5. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound
6. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
7. Known contraindications to tissue-engineered allograft
8. Concurrent participation in alternative clinical trial that involves investigational drug or product interfering with wound treatment and/or healing
9. Subject is pregnant or breastfeeding
10. Subject with history of immunosuppressant treatment (systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the wound surface for \>2 weeks duration within 30 days prior to randomization; or anticipated use of the above during the course of the study
11. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization
12. Open wound with active infection
13. Wound depth with visible exposed bone
14. HBOT within 14 days prior to randomization
15. Revascularization surgery on the index wound leg within 30 days of screening phase
16. Index wound suspicious of neoplasm in the opinion of the principal investigator

Where this trial is running

Denham Springs, Louisiana and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Open WoundChronic woundsWound MedicineCellular, Acellular, Matrix-like ProductCellular and/or Tissue ProductDehydrated Complete Human Placental Membrane
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.