RecruitingNot Applicable

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)

United States200 participantsStarted 2026-03-18

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Subjects must be at least 18 years of age or older.
✓. Index Ulcer must be of venous origin, as determined by clinical signs and symptoms (e.g. hyperpigmentation of the surrounding skin, history of swelling, varicosities, lipodermatosclerosis and/or dermatitis) or other assessments (e.g. venous reflux test)
✓. The index ulcer must have been present for a minimum of 4 weeks
✓. The subject must have a study wound that falls within a specified size range

Exclusion criteria

✕. Index ulcer is located on the leg, below the knee and at or above the malleoli.
✕. Partial or full-thickness index ulcer extending into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule.
✕. The subject must be willing and able to participate, understand, and sign the IRB approved informed consent process prior to any study procedures.
✕. Subjects agree to be compliant with all study requirements, including weekly study visits.
✕0. Females of childbearing potential must use acceptable methods of contraception (birth control pills, barriers, or abstinence) for at least one month prior to randomization and for the duration of study participation. Males must be willing to use acceptable methods of birth control (barriers or abstinence) from randomization through study participation.
✕1. Adequate circulation to the affected limb as documented by any of the following methods performed within 3 months prior to the first screening visit:

What they're measuring

The proportion of subjects that obtain complete closure

Timeframe: 16 weeks

Trial details

NCT IDNCT07510412

SponsorOrganogenesis

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-04

Contact for this trial

Alex Erb

570-560-1269 aerb@organo.com

View on ClinicalTrials.gov More Venous Leg Ulcers trials