| Eligibility |
Inclusion Criteria:
General
Potential subjects are required to meet all of the following criteria for enrollment into
the study and subsequent randomization:
1. At least 18 years old.
2. The index wound (i.e. current episode of the wound or ulceration) has been present for
greater than 4 weeks prior to SV 1 and has had less than 1 year of documented medical
treatment, as of the subject's consent for the study participation.
3. The index wound is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1.
4. Subject understands and is willing to participate in the clinical study and can comply
with weekly visits.
5. Subject must have read and signed the IRB approved Informed Consent Form (ICF) before
study specific screening procedures that are not standard of care are undertaken.
DFU
6. Presence of diabetic foot ulcer (DFU) that meets all of the following features:
7. Wagner Grade 1 or 2 (see Appendix A for definitions), including wounds that extend to
the ligament, tendon, joint capsule or fascia
8. Without abscess or osteomyelitis
9. The index ulcer will be the largest ulcer if two or more DFUs are present and will be
the only one evaluated in the study. If other ulcerations are present on the same
foot, they must be more than 2cm distant from index ulcer (edge to edge).
10. The index ulcer has been offloaded for at least 14 days prior to randomization
11. Adequate circulation to the affected foot as documented by a Clarifi SFDI Vascular
Assessment Tool, or an Ankle Brachial 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 bi-phasic dorsalis pedis and posterior
tibial vessels at the level of the ankle within 3 months of SV1 or if monophasic wave
forms present must have adequate micro circulation as evidenced by Clarifi SFDI
Vascular Assessment Tool. Note: A documented record of an ABI test performed using the
index ulcer leg, within 3 months of SV1 is acceptable for the purposes of this study.
Otherwise, this must be completed in the Screening Visit. Acceptable alternatives
include arterial Doppler ultrasound evaluating vessels at the level of the ankle, or
documented adequate microcirculation as determined by a Clarifi SFDI Vascular
Assessment Tool.
VLU
12. All wounds using the CEAP VLU Classification, except for those in the exclusion
criteria. (See Appendix A for definitions)
13. The index ulcer will be the largest ulcer if two or more VLUs are present and will be
the only one evaluated in the study. If other Ulcerations are present on the same leg,
they must be more than 2cm distant from index ulcer.
14. Adequate circulation to the affected foot as documented by a Clarifi SFDI Vascular
Assessment Tool, or an Ankle Brachial 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 bi-phasic dorsalis pedis and posterior
tibial vessels at the level of the ankle within 3 months of SV1 or if monophasic wave
forms present must have adequate micro circulation as evidenced by Clarifi SFDI
Vascular Assessment Tool. Note: A documented record of an ABI test performed using the
index ulcer leg, within 3 months of SV1 is acceptable for the purposes of this study.
Otherwise, this must be completed in the Screening Visit. Acceptable alternatives
include arterial Doppler ultrasound evaluating vessels at the level of the ankle, or
documented adequate microcirculation as determined by a Clarifi SFDI Vascular
Assessment Tool.
Surgical Dehisced
15. All wounds using the Sandy Grading System, except those in the exclusion criteria.
(See Appendix A for definitions)
Traumatic
16. All wounds as per the CDC Surgical Wound Classification, with the exception of Class
IV or dirty infected wounds, SSI - Deep incisional and organ space. (See Appendix A
for definitions)
Exclusion Criteria:
General
Potential subjects meeting any of the following criteria will be excluded from enrollment
and subsequent randomization:
1. The index wound, in the opinion of the investigator, is suspicious for cancer or have
a positive carcinoma diagnosis.
2. Subject has a history of more than two weeks of treatment with immune-suppressants
(including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or
application of topical steroids to the wound surface within 1 month prior to first
SV1, or who receive such medications during the screening period or who are
anticipated to require such medications during the course of the study.
3. Subject is taking a selective COX-2 inhibitor, such as Celecoxib, for any condition.
4. Subject is on any investigational drug(s) or therapeutic device(s) within 30 days
preceding SV1.
5. History of radiation at the wound site (regardless of time since last radiation
treatment).
6. Index wound has been previously treated or will need to be treated with any prohibited
therapies (See Section 6 of this protocol for a list of prohibited medications and
therapies).
7. Subject has a previous diagnosis of HIV, Hepatitis C, or other contagious diseases.
8. Presence of any condition(s) which seriously compromises the subject's ability to
complete this study or the subject has a known history of poor adherence with medical
treatment.
9. Subject is pregnant or breast-feeding.
10. Presence of diabetes with poor metabolic control as documented with an HbA1c >12.0 %
within 90 days of randomization.
11. Subject has end-stage renal disease as evidenced by a serum creatinine > 3.0mg/dL
within 6 months of randomization.
12. BMI >55
13. PAR experiences a >30% change between SV1 and SV2 DFU
14. Wagner 2 wounds that require debridement of bone.
15. Osteomyelitis or bone infection of the affected foot as verified by x-ray, CAT Scan,
or MRI within 30 days prior to randomization (In the event of an ambiguous diagnosis,
the Principal Investigator will make the final decision).
VLU
16. Exclude
1. Secondary post thrombotic
2. Venous Obstruction
3. Venous Obstruction with reflux
4. Lipodermato sclerosis or atrophic blanche
17. Osteomyelitis or bone infection of the affected leg as verified by x-ray, CAT Scan, or
MRI within 30 days prior to randomization (In the event of an ambiguous diagnosis, the
Principal Investigator will make the final decision).
Surgical Dehisced
18. Using the Sandy Grading System for Surgical Wound Dehiscence: Wounds Grade 3 where
organs are exposed, and 3a, where the infection is severe as deemed by the Principal
Investigator.
Traumatic
19. Using CDC Surgical Wound Classification, exclude
1. Class IV - dirty infected wounds
2. SSI - Deep incisional and organ space
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