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

This is an interventional treatment trial for Venous Leg Ulcers focused on measuring human amniotic membrane, compression therapy, venous leg ulcer Read More

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 but not down to muscle, tendon or bone.
4. The largest ulcer will be designated the index ulcer and the only one included in the study. If other ulcerations are present on the same leg they have to be more than 2 cm apart from the index ulcer.
5. Study ulcer (i.e. current episode of ulceration) has been present for greater than one month prior to the initial screening visit, and has failed to respond to documented conservative measures for greater than (1) one month duration and is excluded if it has undergone 12 months of continuous high strength compression therapy over its duration.
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 prior to randomization.
8. Ulcer has a clean, granulating base with minimal adherent slough at the randomization visit.
9. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
10. Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
11. Subject has read and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.

Exclusion Criteria:

1. Study ulcer(s) deemed by the investigator to be caused by a medical condition other than 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 who cannot tolerate multi-layer compression therapy.
4. Study ulcer, in the opinion of the investigator, is suspicious for cancer should undergo 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 of topical steroids to the ulcer surface within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
6. Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding Screening.
7. Study ulcer improving greater than 30% during the screening phase if the subject was not 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 the Investigator, would make the subject an inappropriate candidate for this ulcer healing study.
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) within the last 30 days
13. Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the course of the trial.
14. Presence of any condition(s) which seriously compromises the subject's ability to complete 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 the malleolus are excluded.
16. Pregnant or breast feeding.
17. Presence of diabetes with poor metabolic control as documented with a HgA1c > 12.0 within last 90 days
18. Patients with renal dysfunction whose serum creatinine levels are 3.0mg/dl or greater within 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