Eligibility Details:
Inclusion Criteria:
- At least 18 years old.
- Presence of a DFU, Wagner 1 (see Appendix B for definitions), extending at least
through the dermis provided it is below the medial aspect of the malleolus.
- The index ulcer will be the largest ulcer if two or more DFUs are present with the
same Wagner grade and will be the only one evaluated in the study. If other
ulcerations are present on the same foot they must be more than 2 cm distant from the
index ulcer.
- Index ulcer (i.e. current episode of ulceration) has been present for greater than 4
weeks prior to SV1 and less than 1-year, as of the date the subject consents for
study.
- Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1.
- 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) between 0.7 and 1.3 within 3 months of SV1, using
the affected study extremity. As an alternative arterial Doppler ultrasound can be
performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the
level of the ankle or a Toe Brachial Index (TBI) of > 0.6 is acceptable.
- The target ulcer has been offloaded for at least 14 days prior to randomization.
- 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.
- Subject understands and is willing to participate in the clinical study and can comply
with weekly visits.
- Subject has read and signed the IRB/IEC approved Informed Consent Form before
screening procedures have been completed.
- The index ulcer has a clean granular base, is free of necrotic debris, and appears to
be healthy vascularized tissue at time of placement of treatment product.
Exclusion Criteria:
- Index ulcer(s) deemed by the investigator to be caused by a medical condition other
than diabetes.
- Index ulcer, in the opinion of the investigator, is suspicious for cancer and should
undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
- Subjects on any investigational drug(s) or therapeutic device(s) within 30 days
preceding the first Screening Visit (SV1).
- History of radiation at the ulcer site (regardless of time since last radiation
treatment).
- Index ulcer has been previously treated or will need to be treated with any prohibited
therapies, such as chlorhexidine or collagenase. (See Section 7.3 of this protocol for
a list of prohibited medications and therapies).
- 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 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 with medical treatment.
- Osteomyelitis or bone infection, cellulitis, or "active" Charcot's arthropathy of the
affected foot near the site of the wound or on the same limb as the index ulcer as
verified by X-ray, MRI, or bone biopsy within 30 days prior to randomization if any of
the aforementioned conditions are expected. (In the event of an ambiguous diagnosis,
the Principal Investigator will make the final decision.)
- Subject is pregnant or breast-feeding.
- Presence of diabetes with poor metabolic control as documented with an HbA1c ≥12.0
within 30 days of randomization.
- Subjects with end stage renal disease as evidenced by a serum creatinine of greater
than 3.0 mg/dl within 120 days of randomization.
- Target wound has presence of local active soft tissue infection or Gangrene involving
the treatment site.
- Index ulcer has reduced in area by 30% or more after 14 days of SOC from SV1 to the
TV1/randomization visit.
- In the opinion of the Investigator, evidence of unstable human immunodeficiency virus
(HIV), hepatitis B or hepatitis C at screening.
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
