RecruitingNot Applicable

Evaluating the Efficacy of NeoThelium FT in the Treatment of Chronic Open Wounds

United States132 participantsStarted 2025-10-16

Plain-language 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 chronic open wounds.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or Female, 18 years of age or older
✓. Subject has a medical diagnosis of "other" Open wound
✓. 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
✓. Subject has a chronic open wound with a historical wound measurement showing less than 25% healing within 14 days prior to screening
✓. Subject has a chronic open wound with screening wound measurement showing less than 25% healing within 14 days prior to randomization
✓. Subject has an Open wound without infection or clinically visible exposed bone
✓. Index wound is a minimum of 0.5cm2 and a maximum of 25cm2 at first treatment visit
✓. Index ulcer has a maximum depth of 1cm at screening visit 1

Exclusion criteria

✕. Subject with a wound diagnosis of diabetic foot wound, pressure wound, venous leg wound, burn wound, or alternative diagnosis other than "open wound"
✕. Subject has a known life expectancy 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
✕. Concurrent participation in alternative clinical trial that involves investigational drug or product interfering with wound treatment and/or healing

What they're measuring

Complete Wound Closure

Timeframe: 1-12 weeks

Trial details

NCT IDNCT06918561

SponsorNuScience Medical Biologics, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-01

Contact for this trial

Angelina Ferguson, DNP

(985) 629-4013 info@sygnola.com

View on ClinicalTrials.gov More Open Wound trials