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)

Conditions

• Venous Leg Ulcers

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• NuShield® — OTHER
  NuShield® is a dehydrated placental allograft

Study Details

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.

Key Dates

Start date

Mar 18, 2026

Status verified

Apr 2026

Primary completion

Apr 30, 2029

Completion

Apr 30, 2029

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: NuShield® plus Standard of Care (SOC)
• No Intervention: Standard of Care (SOC)

Primary Outcome Measure

The proportion of subjects that obtain complete closure [ Time Frame: 16 weeks ]

Central Contacts

• Alex Erb
  570-560-1269
  [email protected]
• Meghan Byrd
  (205) 601-1333
  [email protected]

Locations (1)

Find similar trials in Pickerington, OH

Related Studies

• Comparison of Human Allograft to Apligraf for Venous Leg Ulcers
  Enrolling By Invitation · Solsys Medical LLC · Greenville, South Carolina
• Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers
  PHASE4 · Recruiting · Kerecis Ltd. · Monroeville, Pennsylvania
• Clinical Trial Evaluating an Amnion Membrane Allograft Intended for Use in the Management of Non- Healing Venous Leg Ulcers Versus Standard Of Care Alone
  Recruiting · Skye Biologics Holdings, LLC · Roanoke, Virginia