NCT07510412

Clinical Trial Evaluating NuShield® Plus Standard of Care (SOC) Versus Standard of Care (SOC) Alone in the Management of Non-Healing Venous Leg Ulcers (VLUs)

A Prospective, Multi-Center, Randomized Controlled Clinical Trial Evaluating NuShield® Plus Standard of Care (SOC) Versus Standard of Care (SOC) Alone in the Management of Non-Healing Venous Leg Ulcers (VLUs)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Organogenesis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Prospective, Multi-Center, Randomized Controlled Clinical Trial Evaluating NuShield® plus Standard of Care (SOC) versus Standard of Care (SOC) alone in the Management of Non-Healing Venous Leg Ulcers (VLUs). The study is a prospective, multi-center, open label, RCT designed to collect subject outcome data on NuShield plus Standard of Care vs Standard of Care alone for the management of VLUs.

Conditions

• Venous Leg Ulcers

Interventions

Type	Name	Description
OTHER	NuShield®	NuShield® is a dehydrated placental allograft

Timeline

• Start date: 2026-03-18
• Primary completion: 2029-04-01
• Completion: 2029-04-01
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States