Comparing a Synergistic Antimicrobial Cleanser and Gel to Normal Saline and an Amorphous Gel in Reducing Bioburden and Promoting Healing in Chronic Lower Extremity Ulcers

This is an interventional treatment trial for Wound of Skin Read More

Inclusion Criteria:

1. At least 18 years old
2. Presence of a diabetic foot ulcer, Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the tendon or muscle provided it is below the medial aspect of the malleolus OR Presence of a full thickness venous leg ulcer (VLU)
3. Index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to the initial screening visit.
4. Study ulcer size is a minimum of 0.75 cm2 and a maximum of 5 cm2 at first treatment visit for DFU OR a minimum of 2.0cm2 and a maximum of 20.0 cm2 at the first treatment visit for VLU.
5. Adequate circulation to the affected extremity as demonstrated by a transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, OR an Ankle Brachial Index (ABI - measure of blood flow to the ankle) between 0.7 and ≤ 1.3 OR a toe brachial index >0.5 within 3 months of the first Screening Visit.
6. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
7. Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
8. Subject has read and signed the IRB 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 diabetes or venous disease.
2. A surgery for operative debridement or revascularization is planned for the ulcer to be treated.
3. Index ulcer has a history of cancer or, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
4. Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first Screening Visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
5. History of radiation at the ulcer site.
6. Subject with DFUs who cannot adhere to strict offloading according to protocol standards in the opinion of the investigator.
7. Subjects with VLUs who cannot adhere to multilayer compression.
8. 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.
9. Active treatment of infection anywhere in the body with IV antibiotics, at screening and baseline.
10. Suspected or confirmed signs/symptoms of gangrene on any part of the affected limb.
11. Known Osteomyelitis or bone infection of the affected foot or leg as verified by diagnostic imaging within 30 days prior to enrollment.
12. Subject is pregnant or breast feeding.
13. Study ulcer with a history of treatment with hyperbaric oxygen, growth factors or other biologic treatments, or a Cellular or Tissue-based Product (CTP) within 30 days of enrollment.
14. Subject has a known or suspected allergy to products under study.
15. Pregnancy or breast feeding.