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)

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 refluxtest)

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. Thelargest ulcer satisfying the inclusion and exclusion criteria will be designated asthe 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 subcutaneoustissue without evidence of exposed muscle, tendon, bone, or joint capsule.

8. The subject must be willing and able to participate, understand, and sign the IRBapproved informed consent process prior to any study procedures.

9. Subjects agree to be compliant with all study requirements, including weekly studyvisits.

10. Females of childbearing potential must use acceptable methods of contraception (birth control pills, barriers, or abstinence) for at least one month prior torandomization and for the duration of study participation. Males must be willing touse acceptable methods of birth control (barriers or abstinence) from randomizationthrough study participation.

11. Adequate circulation to the affected limb as documented by any of the followingmethods performed within 3 months prior to the first screening visit:

12. TCOM > 30 mmHg

13. ABI > 0.75

14. SPP > 30mmHg

15. As an alternative, Arterial Doppler ultrasound can be performed evaluating forbiphasic dorsalis pedis and posterior tibial vessels at the level of the ankleon the extremity the index ulcer is located.

16. 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 debridementnecessitating surgery or enzymatic therapies.

4. The surface area measurement of the index ulcer has reduced in size by a specifiedamount from the initial screening visit (SV1) to Visit 1/randomization visit

5. Subjects receiving systemic steroids greater than 5 mg of Cortisone per day orequivalent.

6. A subject who, in the opinion of the Investigator, has a clinically relevant medicalcondition which could impact subject safety, impair treatment effectiveness, orotherwise interfere with their ability to comply with study requirements.

7. Signs and symptoms of index ulcer infection, including but not limited to cellulitisor 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 6months of randomization.

11. Subjects with an HbA1c level of >12% within 3 months of randomization (if thesubject is diabetic).

12. Topical application of steroids to the index ulcer surface within one month ofinitial screening.

13. Subjects who are currently receiving, or who previously received at any time withinone month prior to screening, immunosuppressive agents (including inhaledcorticosteroids and oral cortisone 5 mg or more daily), radiation therapy, orchemotherapy. 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 areunwilling or unable to adhere to the protocol requirements.