Amnioband and Standard of Care vs. Standard of Care Alone in the Treatment of Venous Leg Ulcers

Inclusion Criteria:

1. At least 18 years old.

2. Ankle Brachial Pressure Index (ABI) > 0.75 OR SPP > 30 mmHg OR TCOM > 30 mmHg.*

3. Presence of a venous leg ulcer extending through the full thickness of the skin butnot down to muscle, tendon or bone.

4. The largest ulcer will be designated the index ulcer and the only one included in thestudy. If other ulcerations are present on the same leg they have to be more than 2 cmapart from the index ulcer.

5. Study ulcer (i.e. current episode of ulceration) has been present for greater than onemonth prior to the initial screening visit, and has failed to respond to documentedconservative measures for greater than (1) one month duration and is excluded if ithas undergone 12 months of continuous high strength compression therapy over itsduration.

6. Study ulcer is a minimum of 2 cm2 and a maximum of 20 cm2 at the randomization visit.

7. The target ulcer has been treated with compression therapy for at least 14 days priorto randomization.

8. Ulcer has a clean, granulating base with minimal adherent slough at the randomizationvisit.

9. Females of childbearing potential must be willing to use acceptable methods ofcontraception (birth control pills, barriers, or abstinence).

10. Subject understands and is willing to participate in the clinical study and can complywith weekly visits and the follow-up regimen.

11. Subject has read and signed the IRB/IEC approved Informed Consent Form beforescreening procedures are undertaken.

Exclusion Criteria:

1. Study ulcer(s) deemed by the investigator to be caused by a medical condition otherthan venous insufficiency.

2. Study ulcer exhibits clinical signs and symptoms of infection.

3. Known allergy to the components of the multi-layer compression bandaging, or whocannot tolerate multi-layer compression therapy.

4. Study ulcer, in the opinion of the investigator, is suspicious for cancer shouldundergo an ulcer biopsy to rule out a carcinoma of the ulcer.

5. Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy, or application oftopical steroids to the ulcer surface within one month prior to initial screening, orwho receive such medications during the screening period, or who are anticipated torequire such medications during the course of the study.

6. Subjects on any investigational drug(s) or therapeutic device(s) within 30 dayspreceding Screening.

7. Study ulcer improving greater than 30% during the screening phase if the subject wasnot in adequate compression 14 days prior to screening.

8. History of drug or alcohol abuse.

9. History of radiation at the ulcer site.

10. Presence of one or more medical conditions, as determined by medical history,hematologic, active auto-immune or immune diseases that, in the opinion of theInvestigator, would make the subject an inappropriate candidate for this ulcer healingstudy.

11. History of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.

12. Study ulcer has been previously treated with tissue engineered materials (e.g.Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) withinthe last 30 days

13. Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during thecourse of the trial.

14. Presence of any condition(s) which seriously compromises the subject's ability tocomplete this study, or has a known history of poor adherence with medical treatment.

15. Ulcers on the dorsum of the foot or with more than 50% of the ulcer below themalleolus are excluded.

16. Pregnant or breast feeding.

17. Presence of diabetes with poor metabolic control as documented with a HgA1c > 12.0within last 90 days

18. Patients with renal dysfunction whose serum creatinine levels are 3.0mg/dl or greaterwithin the last 90 days

19. History of usage of tobacco products within the last 30 days

20. History of Liver disease with active Cirrhosis of the liver