| Eligibility |
Inclusion Criteria:
1. Male or female = 18 years
2. A signed and dated informed consent form has been obtained from the subject
3. Confirmed Type 1 or 2 diabetes with a hemoglobin HbA1c =12% within 90 days of informed
consent
4. Current reference ulcer has been in existence for longer than four (4) weeks with
confirmed failure of a prior treatment to heal the ulcer, prior to signing informed
consent for trial participation. Verbal statement from prior treating clinician or
patient can be used as confirmation of treatment failure.
5. Reference ulcer has been diagnosed as either a partial or full thickness diabetic foot
ulcer without tunneling, undermining, sinus tracts or /exposed bone, with a scale
rating of a Wagner Grade 1 or Wagner Grade 2 extended to ligament, tendon, and joint
capsule with no bone exposure
6. Ulcer is either located on the foot or ankle with at least 50% of ulcer below medial
aspect of the malleolus
7. Ulcer size (area) =1cm² and =25cm² post-debridement at both screening visit 1 and at
baseline/randomization visit 3
8. There is a minimum 1cm margin between the qualifying reference study ulcer and any
other ulcers on the specified foot, post debridement
9. Subject has adequate vascular perfusion of the affected limb, as defined by at least
one of the following:
1. Ankle-brachial Index (ABI) = 0.65 or =1.2
2. Toe pressure (plethysmography) >50mmHg
3. TcPO2 >40mmHg
4. Or as an alternative, the arterial Doppler ultrasound can be performed evaluating
for biphasic dorsalis pedis and posterior tibial vessels at the level of the
ankle or a TBI (Toe Brachial Index) of > 0.6 is acceptable.
10. Subject or responsible caregiver is willing and able to adhere to schedule of required
applicable dressing changes as well as off-loading for the location of the reference
ulcer
11. Subject is able and willing to comply with study procedures
12. Females of childbearing potential must be willing to use acceptable methods of
contraception (birth control pills, barriers, or abstinence) during the course of the
study and undergo pregnancy tests.
13. A two-(2) week run-in period will Standard of Care treatment plus required offloading
precede randomization in the trial to document the indolent nature of the subject's
selected selected. The subject may be randomized if the reference ulcer has not
reduced in area >30% from screening visit 1 to baseline/randomization visit 3.
Exclusion Criteria:
1. Subject was previously randomized and treated under this clinical study protocol
2. Subject has suspected or confirmed signs/symptoms of gangrene or wound infection as
evidenced by redness, pain, and purulent drainage on any part of the index limb as
confirmed by X-ray or biopsy
3. Subject has a history of hypersensitivity to polyurethane, as determined by prior
medical history
4. Subject has participated in another clinical trial involving a device or a
systemically administered investigational study drug/treatment within 30 days of
randomization
5. Subject has received, or is scheduled to receive a medication or treatment which is
known to interfere with or affect the rate or quality of wound healing within 30 days
of signing the informed consent form
6. Subject has a history of bone cancer or metastatic disease on the index limb,
radiation therapy to the foot, or has had chemotherapy within twelve (12) months prior
to signing informed consent form for trial participation
7. Reference ulcer, in the clinical opinion of the investigator, is suspicious for cancer
and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer
8. Subject has a condition that would interfere with their ability to adhere with the
treatment regimen or has a known history of poor adherence with medical treatment
9. In the opinion of the Investigator, the subject has a history of or is currently
diagnosed with any illnesses or conditions, other than diabetes, that could interfere
with wound healing such as auto-immune disorders, end-stage renal disease, severe
malnutrition, liver disease or connective tissue disorders
10. In the clinical opinion of the Investigator, the subject has an active or unstable
Charcot foot
11. Subject has ulcers secondary to a disease other than diabetes (e.g., vasculitis,
neoplasms, or hematological disorders)
12. In the clinical opinion of the Investigator, the subject has excessive lymphoedema
that could interfere with off-loading and/or wound healing
13. Subject with an active infection at the reference ulcer
14. Subject has a non-healed surgical site from a prior amputation located in the index
limb that has been open for less than 30 days
15. Subject has been treated with wound dressings that include growth factors, engineered
tissues or skin substitutes within 30 days of randomization or is scheduled to receive
treatment during the study
16. Subject has been treated with hyperbaric oxygen or topical oxygen therapy within five
(5) days of the Screening Visit or is scheduled to receive hyperbaric oxygen treatment
or topical oxygen therapy during the study
17. Subject has been treated with Negative Pressure Wound Therapy (NPWT) within 72 hours
of the Screening Visit
18. Subject receiving dialysis treatment: hemodialysis or peritoneal dialysis
19. Subject has received an organ transplant
20. Subjects with a history of more than two (2) weeks treatment with immunosuppressants
including prednisone 10 mg daily or an equivalent dose of other oral steroids, or
application of topical steroids to the ulcer surface within one (1) 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
21. Active osteomyelitis or bone infection of the index foot. A subject may be enrolled in
study if the subject:
1. is at least 8 weeks post osteomyelitis diagnosis
2. has been treated appropriately
3. has only intact joint capsule exposed with no bone exposure
22. Subjects presenting with an ulcer probing to bone (Wagner Grade 3)
23. Subject is currently pregnant or actively trying to conceive.
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