Status: Recruiting

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). 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.

Participants needed: 200

Trial details

Age: 18+Biological sex: AllType: InterventionalSponsor: OrganogenesisUpdated: Apr 3, 2026Locations: 1

Eligibility criteria

Subjects must be at least 18 years of age or older. [+4]

Index ulcer is located on the leg, below the knee and at or above the malleoli. [+24]

Status: Recruiting

A Study to Evaluate the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix With Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers

This prospective, multi-center, randomized, controlled modified platform Trial compares Purified Native Type 1 Collagen Extracellular Matrix with Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care versus Standard of Care Alone in subjects with chronic DFUs.

Participants needed: 170

Trial details

Age: 18+Biological sex: AllType: InterventionalSponsor: OrganogenesisUpdated: Apr 4, 2025Locations: 1

Eligibility criteria

At least 18 years of age or older. [+7]

Target ulcers located on the plantar aspect of the foot must be offloaded for at... [+21]

Clinical trials

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 Study to Evaluate the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix With Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers