| Eligibility |
Inclusion Criteria:
- Have participated in the informed consent process and signed a study-specific informed
consent document
- Be willing to comply with study procedures, including study visits, and compliance
with study required off-loading/protective device for the duration of the study
- Be at least 18 years of age
- If female and of child-bearing potential, must not be pregnant. To document pregnancy
status, subject statement is acceptable
- Have Type II or Type II diabetes mellitus with investigator-confirmed glycosylated
hemoglobin (HbA1c) of less than or equal to 12% within 3 months prior to Screening
Visit
- Have at least one diabetic foot ulcer that meets ALL the following criteria:
1. Ulcer which has been in existence for a minimum of four weeks, prior to signing
the Informed Consent Form allowing trial participation
2. Ulcer is a partial or full thickness diabetic foot ulcer without
capsule/tendon/bone exposure
3. Ulcer does not have tunneling, undermining, or sinus tracts that necessitates
surgical OR debridement and/or penetrates to capsule/tendon/bone
4. Ulcer is located on the foot or ankle (with no portion above the top of the
malleolus)
5. Ulcer size (area) is greater than equal to 1 cm2 and less than equal to 12 cm2
post-debridement
- Have a minimum 4cm margin between the qualifying study ulcer and any other ulcer on
that same foot, post-debridement
(a) If the subject has more than one ulcer that meets eligibility criteria, the ulcer
designated as the study ulcer will be at the discretion of the investigator
- Have adequate vascular perfusion of the affected limb as defined by at least one of
the following within the past 60 days:
1. Ankle-Brachial Index (ABI) greater than equal to 0.7 and less than equal to 1.2,
performed within 60 days of screening,
2. Toe pressure (plethysmography) > 40 mmHg at time of screening, or
3. TcPO2 > 50 mmHg at time of screening
- Be willing and able to maintain required applicable dressing changes as well as study
required off-loading/protective device for the duration of the study
- Have a study wound severity Wagner I or II
Exclusion Criteria:
- Previously randomized and treated under this clinical study protocol
- Patients with a known history of poor compliance with medical treatments
- Suspected or confirmed gangrene or ulcer infection of the study ulcer or is receiving
systemic/IV antibiotics at the time of randomization
- Suspected or confirmed osteomyelitis of the foot with the study ulcer
- Participated in another clinical trial involving a device or a systemically
administered investigational study drug/treatment within 28 days of randomization
- Received within 28 days of signing Informed Consent Form, or is scheduled to receive
during study participation, a medication or treatment which is known to interfere with
or affect the rate and quality of ulcer healing (e.g., systemic steroids,
immunosuppressive therapy, autoimmune disease therapy, dialysis, radiation therapy to
the foot, vascular surgery, angioplasty, or thrombolysis)
- History of bone cancer or metastatic disease of the affected limb, radiation therapy
to the foot, or has had chemotherapy (i.e., systemic steroids, anti-rheumatics, TNF
inhibitors, active chemotherapy, immunosuppressive therapy, autoimmune disease
therapy) within 12 months prior to signing Informed Consent Form allowing trial
participation
- In the opinion of the investigator, the subject has a history of, or is currently
diagnosed with, any illness or condition, other than diabetes, that could interfere
with ulcer healing (e.g., end-stage renal disease, severe malnutrition, liver disease,
aplastic anemia, connective tissue disorder, acquired immune deficiency syndrome, HIV
positive, or sickle cell anemia)
- In the opinion of the investigator, the subject has unstable Charcot foot or Charcot
with bony prominence that could inhibit ulcer healing
- Have ulcers secondary to a disease other than diabetes (e.g., vasculitis, neoplasms,
or hematological disorders)
- In the opinion of the investigator, the subject has excessive lymphedema that could
interfere with off-loading and/or ulcer healing
- Study Ulcer has received ulcer dressings that included growth factors, engineered
tissues, or skin substitutes within 28 days of randomization, or is scheduled to
receive such treatment during the study (e.g., Regranex, Dermagraft, Apligraf, EpiFix,
Grafix, GraftJacket, OASIS, Omnigraft, or Integra BMWD)
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