Actively 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)
Led by Organogenesis · Updated on 2026-04-03
200
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
Sponsors
O
Organogenesis
Lead Sponsor
P
Professional Education and Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age or older
- Venous origin index ulcer confirmed by clinical signs or assessments
- Ulcer present for at least 4 weeks
- Ulcer size within specified study range
- If multiple ulcers, must be separated by at least 2 cm; largest ulcer is the index ulcer
- Ulcer located on the leg below the knee and at or above the ankle
- Partial or full-thickness ulcer extending into dermis or subcutaneous tissue without exposed muscle, tendon, bone, or joint capsule
- Willing and able to participate and sign informed consent
- Agree to comply with all study requirements including weekly visits
- Females of childbearing potential must use accepted contraception for at least one month prior and during study; males must also use contraception
- Adequate circulation to affected limb documented by specified methods within 3 months prior to screening
- Failed to adequately respond to conventional therapy
You will not qualify if you...
- Index ulcer is not of venous origin
- Unable to tolerate sharp debridement and standard compression therapy
- Wound requires surgical or enzymatic debridement as judged by investigator
- Ulcer surface area reduced by specified amount between screening and randomization
- Receiving systemic steroids over 5 mg cortisone daily or equivalent
- Medical conditions impacting safety, treatment effectiveness, or compliance
- Signs of ulcer infection such as cellulitis or osteomyelitis
- Necrotic or avascular ulcer beds
- Ulcer exposes muscle, tendon, bone, or joint capsule
- Receiving hemodialysis or creatinine level over 3.0 mg/dL within 6 months
- HbA1c level over 12% within 3 months if diabetic
- Topical steroid use on ulcer within one month prior to screening
- Receiving or planned immunosuppressive agents, radiation therapy, or chemotherapy within one month prior to screening
- Pregnant or breastfeeding
- History of poor compliance or unwillingness to adhere to protocol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cutting Edge Research
Pickerington, Ohio, United States, 43113
Actively Recruiting
Research Team
A
Alex Erb
CONTACT
M
Meghan Byrd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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