NuShield plus usual care versus usual care alone for non-healing venous leg ulcers

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)

This trial tests whether adding NuShield to standard wound care helps adults with non-healing venous leg ulcers heal faster than standard care alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Organogenesis (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Pickerington, Ohio)
• Trial ID: NCT07510412 on ClinicalTrials.gov

What this trial studies

This prospective, multi-center, open-label randomized controlled trial compares NuShield plus standard of care to standard of care alone in adults with non-healing venous leg ulcers. Eligible participants are adults with a venous-origin leg ulcer below the knee that has been present at least four weeks and meets size and depth criteria. Participants are randomized to receive either NuShield with usual wound care or usual care alone, with scheduled visits to measure wound size and healing outcomes over the follow-up period. The study will collect objective outcome data to determine whether the adjunctive product improves closure rates or healing speed compared with standard therapy.

Who should consider this trial

Good fit: Adults (≥18) with a venous-origin leg ulcer located below the knee and at or above the malleoli that has been present for at least four weeks and meets the study's size and depth criteria.

Not a fit: Patients with non-venous ulcers, ulcers with exposed muscle/tendon/bone, severe ischemia or uncontrolled infection, or those unable to attend the Ohio site are unlikely to receive benefit from this trial.

Why it matters

Potential benefit: If successful, adding NuShield could speed ulcer closure, reduce infection risk, and shorten the time living with a chronic wound.

How similar studies have performed: Other randomized trials of adjunctive dressings and biologic grafts for venous leg ulcers have shown mixed but sometimes promising results, while NuShield itself has limited published evidence.

Eligibility criteria

Inclusion Criteria:

1. Subjects must be at least 18 years of age or older.
2. 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)
3. The index ulcer must have been present for a minimum of 4 weeks
4. The subject must have a study wound that falls within a specified size range
5. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the index ulcer.
6. Index ulcer is located on the leg, below the knee and at or above the malleoli.
7. Partial or full-thickness index ulcer extending into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule.
8. The subject must be willing and able to participate, understand, and sign the IRB approved informed consent process prior to any study procedures.
9. Subjects agree to be compliant with all study requirements, including weekly study visits.
10. 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.
11. Adequate circulation to the affected limb as documented by any of the following methods performed within 3 months prior to the first screening visit:

    1. TCOM \> 30 mmHg
    2. ABI \> 0.75
    3. SPP \> 30mmHg
    4. As an alternative, Arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle on the extremity the index ulcer is located.
12. Subject failed to adequately respond to conventional therapy

Exclusion Criteria:

1. Index ulcer is of non-venous pathophysiology.
2. Subjects unable to tolerate sharp debridement and standard compression therapy.
3. If, at the opinion of the investigator, the index wound requires debridement necessitating surgery or enzymatic therapies.
4. The surface area measurement of the index ulcer has reduced in size by a specified amount from the initial screening visit (SV1) to Visit 1/randomization visit
5. Subjects receiving systemic steroids greater than 5 mg of Cortisone per day or equivalent.
6. A subject who, in the opinion of the Investigator, has a clinically relevant medical condition which could impact subject safety, impair treatment effectiveness, or otherwise interfere with their ability to comply with study requirements.
7. Signs and symptoms of index ulcer infection, including but not limited to cellulitis or osteomyelitis (as evidenced by Investigator's exam or x-ray).
8. Necrotic or avascular index ulcer beds.
9. Index ulcer contains exposed muscle, tendon, bone, or joint capsule.
10. Subjects receiving hemodialysis or having a creatinine level of \> 3.0mg/dL within 6 months of randomization.
11. Subjects with an HbA1c level of \>12% within 3 months of randomization (if the subject is diabetic).
12. Topical application of steroids to the index ulcer surface within one month of initial screening.
13. Subjects who are currently receiving, or who previously received at any time within one month prior to screening, immunosuppressive agents (including inhaled corticosteroids and oral cortisone 5 mg or more daily), radiation therapy, or chemotherapy. Anticipated use of any of the above agents is considered exclusionary.
14. Subjects who are pregnant or breast-feeding.
15. Subjects with a history of poor compliance with medical treatment or who are unwilling or unable to adhere to the protocol requirements.

Where this trial is running

Pickerington, Ohio

• Cutting Edge Research — Pickerington, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: Alex Erb

Conditions Venous Leg Ulcers; VLU; Non- Healing Venous Leg Ulcers; Chronic Venous Leg Ulcers