NCT06930768

Evaluating the Efficacy of NeoThelium FT in the Treatment of Venous Leg Ulcers

Evaluation of the Efficacy of NeoThelium FT in the Healing of Venous Leg Ulcers: A Randomized Controlled Multicenter Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: NuScience Medical Biologics, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized controlled trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating venous leg 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 be randomly assigned to one of two groups: either standard of care alone, or standard of care plus NeoThelium FT. As this is a post-marketing study, it will gather information about how effective the treatment is in treating venous leg ulcers. All subjects will complete two week screening phase prior to being randomized into a treatment arm. Treatment arms will consist of NeoThelium FT in conjunction with standard of care, vs. standard of care alone. The primary endpoint will be the percentage of target ulcers that achieve complete wound closure within 16 weeks. Secondary endpoints consist of wound area reduction rates, time to closure, follow-up closure, and pain assessment.

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
OTHER	Standard of Care	Wound cleansing, Sharps debridement, Dressing for moisture balance, Offloading
OTHER	NeoThelium FT	NeoThelium FT is a dehydrated wound covering derived from donated human placental tissue. NeoThelium FT is a dual-layer membrane with amnion and chorion combination layers.

Timeline

• Start date: 2026-07-01
• Primary completion: 2027-03-01
• Completion: 2027-06-01
• First posted: 2025-04-16
• Last updated: 2026-04-13