| Eligibility |
Inclusion Criteria:
- Able to read, understand and sign the informed consent form (ICF)
- Available and willing to complete all study assessments
- At least 12 weeks post lower extremity revascularization procedure, if one has been
performed
- Have chronic ulcer(s) of the lower extremities with the following characteristics:
- Of diabetic or vascular etiology
- Duration of =4 weeks, unresponsive to SOC
- =20 cm2 in area
- Extend through the full thickness of the skin but not down to muscle, tendon, or
bone
- For subjects with VLU:
- Ulcer area is =1.5 cm2 and =20 cm2 and with a clean, granulating base with
minimal adherent slough
- Ulcer location is at or above the ankle (malleolus) and below the knee
- Ulcer location is appropriate for use of compression therapy treatment
- For subjects with DFU:
- Ulcer area is =1.5 cm2 and = 20 cm2 and is amenable to off-loading
- Subject has diabetes mellitus (Type 1 or Type 2), requiring insulin or
oral/injectable medications to control blood glucose levels
- Glycosylated hemoglobin (HbA1c) level at screening is <12%
- Adequate circulation to the affected lower extremities
- Total serum bilirubin, alanine aminotransferase (ALT) and/or aspartate
aminotransferase (AST), hemoglobin, WBC, and PLT count all within limits specified in
study protocol
- No renal impairment or mild renal impairment, defined as creatinine clearance =50
mL/min (by Cockroft-Gault estimation)
- Male subjects and female subjects of childbearing potential must use acceptable
methods of contraception
Exclusion Criteria:
- Clinical evidence of ongoing infection and/or receipt of IV, oral, or topical
antimicrobials at the Baseline Visit
- Wheelchair bound or bed-ridden (ambulatory with assistance is acceptable)
- Ulceration at the site of amputation
- Undergoing renal dialysis
- Known or suspected malignancy in the target ulcer, or a history of cancer in the
preceding 5 years (other than carcinoma in situ of the cervix or adequately treated
non-melanoma skin cancer)
- Documented history of osteomyelitis at the target ulcer location within 6 months of
screening
- Current treatment or anticipated need for treatment over the course of the study with:
- Immunosuppressants (including topical or systemic corticosteroids or
glucocorticoids)
- Cytotoxic chemotherapy
- Growth hormone
- Oral or systemic antifungal or antituberculosis treatment
- History of radiation at the ulcer site
- New York Heart Association Class III or IV congestive heart failure or uncontrolled
cardiac dysrhythmia
- Diagnosis of autoimmune disease(s) (rheumatoid arthritis, lupus, psoriasis, Sjogren's
syndrome) or arthritis requiring corticosteroid treatment
- Target ulcer(s) previously treated with negative pressure, hyperbaric oxygen, or
tissue engineered materials (eg, Apligraf®, EpiFix® or Dermagraft®) or other scaffold
materials (eg, Oasis, Matristem) within 4 weeks prior to Screening Visit
- Target ulcer(s) anticipated to require negative pressure wound therapy or hyperbaric
oxygen at any time during the study
- Subjects with VLU who have:
- Deep vein thrombosis diagnosed within 4 weeks prior to Screening Visit
- Refusal or inability to tolerate compression therapy
- Subjects with DFU who have:
- Active Charcot foot (stable chronic Charcot foot is not exclusionary)
- Ulcers on toes 2, 3, 4, and/or 5 only (ulcer on plantar surface of the great toe
only is not exclusionary)
- Pregnant or breast feeding
- Allergic to DMSO
- Healing of target ulcer is observed to be =35% at the end of the Run-in Period
(between Screening and Baseline Visits)
- Presence of any condition(s) which compromises the subject's ability to complete this
study, including subjects with a known history of poor adherence to medical treatment
- Subjects who, in the opinion of the Investigator, are not able to comply with study
requirements
- Treatment with an investigational drug(s) or device(s) within the 4 weeks preceding
Screening
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