200 Participants NeededMy employer runs this trial

NuShield® for Venous Leg Ulcer

AE
MB
Overseen ByMeghan Byrd
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

MR

Maribel Riesco

Principal Investigator

Organogenesis

Are You a Good Fit for This Trial?

Inclusion Criteria

My ulcer is caused by vein problems in my leg.
My ulcer has been present for at least 4 weeks.
4. The subject must have a study wound that falls within a specified size range
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NuShield plus Standard of Care or Standard of Care alone for the management of VLUs

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NuShield®

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: NuShield® plus Standard of Care (SOC)Experimental Treatment1 Intervention
Group II: Standard of Care (SOC)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Organogenesis

Lead Sponsor

Trials
37
Recruited
4,400+

Professional Education and Research Institute

Collaborator

Trials
16
Recruited
1,400+