| Eligibility |
Inclusion Criteria:
- At least 18 years of age.
- Documented history of Type I or Type II Diabetes Mellitus requiring oral and/or
insulin replacement therapy.
- Presence of a DFU Wagner 1 grade wound on any aspect of the foot, provided that if the
malleolus is involved, not more than 50% of the wound is above the mid-point of the
medial malleolus. [NOTE: DFU must maintain Wagner 1 Grade for the duration of study
run-in period - i.e., screening visit 1 (SV1) to randomization visit 1 (RV1).]
- If other wounds are present on the same foot, they must be more than 2 cm distant from
the index ulcer. [NOTE: If two or more DFUs are present with the same grade, the index
ulcer is the largest ulcer and the only one evaluated in the study.]
- Index ulcer (i.e., current episode of ulceration) has been present for = four weeks
(=28 days) prior to the initial screening visit (SV1).
- Index ulcer (post-debridement) is a minimum of 1.0 cm2 and a maximum of 15 cm2 at
first screening visit (SV1) and first randomization visit (RV1).
- Adequate circulation to the affected foot as documented by a dorsal transcutaneous
oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of = 30 mmHg,
or an Ankle Branchial Index (ABI) of = 0.7 and = 1.2, or Arterial Doppler with a
minimum of biphasic flow or Toe Brachial Index (TBI) = 0.75, using the affected study
extremity within 30 days of screening visit (SV1).
- Index ulcer and/or index ulcer limb may have had prior infection(s), but infection(s)
must be adequately treated and controlled as defined by IDSA Guidelines PEDIS Grade
level 1.
- The index ulcer has been offloaded with protocol defined offloading device throughout
study run-in period for at least 14 days prior to randomization (Run-in period defined
as Screening through RV1/Randomization).
- Negative pregnancy test for females of childbearing potential (e.g., not post-
menopausal for at least one year or surgically sterile).
- Subject understands and is willing to participate in the clinical study and can comply
with study visits and the follow-up regimen.
- Females of childbearing potential must agree to use effective methods of c
contraception (birth control pills, barriers, or abstinence) (Screening through End of
Study (EOS) and undergo pregnancy tests.
- Properly obtained written informed consent.
- Subject must have stable living environment in order to manage offloading and wound
care management.
- The index ulcer has a clean base, free of necrotic debris, and infection at time of
placement of treatment product.
Exclusion Criteria:
- Index ulcer and/or index limb with presence of gangrene or unstable ischemia at
screening (SV1).
- Revascularization surgery on the lower extremity on which the index ulcer is located
within 30 days of screening visit (SV1).
- Index ulcer in the opinion of the investigator, is suspicious for cancer and should
undergo an ulcer biopsy to rule out a neoplasm of the ulcer.
- Subjects with history of radiation on the same limb as the index ulcer (regardless of
time since last radiation treatment).
- Subjects with exposed internal fixation on the same limb as the index ulcer [NOTE:
External fixation is allowed if deemed stable by principal investigator.]
- Subjects on any investigational drug(s) or therapeutic device(s) within 30 days
preceding the first screening visit (SV1). [NOTE: NPWT is allowed up to the day of
screening (SV1), if in the opinion of the Principal Investigator NPWT may be
discontinued.]
- Index ulcer treated within the last 30 days prior to screening with a prohibited
treatment as defined in full protocol.
- Subjects with a history of more than two weeks treatment with immunosuppressants
(including systemic corticosteroids > 10mg prednisone (or equivalent) daily dose),
cytotoxic chemotherapy, or application of topical steroids to the index ulcer surface
within 30 days prior to first screening visit (SV1), or who receive such medications
during the run-in period, or who are anticipated to require such medications during
the study.
- Presence of any condition(s) which seriously compromises the subject's ability to
complete this study or has a known history of poor adherence to medical treatment.
- In the opinion of the Investigator, the subject is non-compliant with offloading or
index ulcer dressing during the run-in period.
- Active Charcot's arthropathy of the index ulcer limb as verified by clinical
evaluation, and/or imaging (x-ray or MRI) within 30 days prior to randomization (RV1).
- Subjects with chronic osteomyelitis and/or cellulitis on the same limb as the index
ulcer as verified by clinical evaluation, and/or imaging (x-ray or MRI) within 30 days
prior to randomization (RV1).
- Subject is pregnant or breast-feeding.
- Presence of diabetes with poor metabolic control as documented with an HbA1c =12.0
within 30 days prior to randomization (RV1).
- Subjects with end stage renal disease requiring treatment with dialysis and/or evident
by an eGFR <30 mL/min/1.73m2 within 120 days of randomization (RV1). [NOTE: Subjects
with two documented eGFR values within 120 days, the most recent value may be used if
the eGFR =30 mL/min/1.73m2 and is, in the opinion of the principal investigator,
stable and the subject will not require treatment with dialysis for the duration of
study participation.]
- Index ulcer has reduced or increased in area by 30% or more after 14 days of SOC from
SV1 to the RV1/randomization visit.
- Evidence of unstable human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis
C in the opinion of the investigator at screening (SV1).
- Documented history of New York Heart Association Class III or IV congestive heart
failure or unstable cardiovascular disease requiring intervention within 60 days prior
to screening (SV1).
- Requiring surgical intervention (excluding debridement) at the time of consenting
and/or increased probability of requiring surgical intervention during study
participation. [NOTE: non-invasive surgical intervention is allowed if, per the
Principal Investigator, treatment will not affect subject's ability to participate in
clinical trial.]
- Any clinically significant finding, in the judgment of the investigator, that would
place the subject at health risk, impact the study, or affect the completion of the
study.
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