Actively Recruiting
A Prospective, Multi-Center, Randomized Controlled Clinical Trial Evaluating NuShield4 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
N/A
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
Researchers are evaluating the use of NuShield4, a dehydrated placental allograft, combined with standard care compared to standard care alone for treating non-healing venous leg ulcers (VLUs). This prospective, multi-center, randomized controlled trial aims to gather outcome data on wound healing effectiveness in adults with VLUs. The study is sponsored by Organogenesis and focuses on ulcers that have not healed with conventional treatment. Participants will be randomly assigned to receive either NuShield4 plus standard care or standard care alone. Standard care includes standard compression therapy and wound management. The study measures include the proportion of subjects achieving complete wound closure by 16 weeks, with secondary outcomes assessing closure by 12 weeks, time to closure, and percentage reduction in wound area. Weekly study visits will support treatment and monitoring. During the trial, participants will attend weekly visits for wound assessment and treatment. Researchers will evaluate wound healing progress using clinical evaluations and document outcomes like total wound closure and wound size reduction. The study requires participants to comply with all visits and procedures, including informed consent and contraception use for those of childbearing potential. The total duration for primary outcome assessment is 16 weeks, with safety and compliance monitored throughout.
CONDITIONS
Brief 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...
- Subjects must be at least 18 years of age or older
- Ulcer must be of venous origin as determined by clinical signs or tests
- Ulcer must have been present for at least 4 weeks
- Ulcer size must fall within a specified range
- If multiple ulcers, they must be at least 2 cm apart; largest ulcer is index ulcer
- Index ulcer located on leg below knee and at or above the ankle bone
- Ulcer extends into dermis or subcutaneous tissue without exposed muscle, tendon, bone, or joint capsule
- Participants must be able and willing to consent and participate
- Willingness to comply with all study requirements including weekly visits
- Females of childbearing potential must use contraception from one month before randomization through study
- Males must use contraception from randomization through study
- Adequate circulation to affected limb documented by specified tests within 3 months
- Subject has failed to respond adequately to conventional therapy
You will not qualify if you...
- Ulcer is not of venous origin
- Unable to tolerate sharp debridement and compression therapy
- Ulcer requires surgical or enzymatic debridement per investigator
- Ulcer size reduced by specified amount between screening visits
- Use of systemic steroids greater than 5 mg cortisone daily or equivalent
- Clinically relevant medical condition impacting safety or study compliance
- Signs of ulcer infection such as cellulitis or osteomyelitis
- Necrotic or avascular ulcer beds
- Ulcer with exposed muscle, tendon, bone, or joint capsule
- Receiving hemodialysis or creatinine level above 3.0 mg/dL within 6 months
- HbA1c over 12% within 3 months if diabetic
- Topical steroids applied to ulcer within one month prior to screening
- Use of immunosuppressive agents, radiation, or chemotherapy within one month prior to screening
- Pregnant or breastfeeding
- History of poor compliance or unwillingness to adhere to protocol requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Weekly visits for up to 2 to 4 weeks
Duration - Up to 16 weeks
Participants receive either NuShield® plus Standard of Care or Standard of Care alone to manage their non-healing venous leg ulcers.
Weekly visits during treatment
Trial Site Locations
Total: 1 location
1
Cutting Edge Research
Pickerington, Ohio, United States, 43113
Actively Recruiting
Research Team
A
Alex Erb
M
Meghan Byrd
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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