Characterization of AmnioExcel Plus in Two Treatment Paradigms

Study Procedures:

Collection of Demographic data, medical/social history Collection of medications1 Ankle Brachial Index2 Wound debridement3 (standard of care procedure) Imaging with eKare4 Hyperspectral Imaging Application of study product

• Only collect antibiotics, anti-fungal and anti-infective medications.
• ABI (with toe pressure) can be done at screening or baseline.
• Once wound is healed, wound debridement will not be done at weekly visits.
• Once wound is healed, eKare will not be done at weekly visits.
• EOS will occur on the date the subject is healed. *Screening and Visit 1 may be done on the same day.

Screening and Enrollment*:

• Review and sign the Informed Consent and HIPAA Authorization
• Review the inclusion and exclusion criteria

If the subject qualifies for the study, they will participate in the following procedures (weekly visits, +/-4 days):

Visit 1*:

• Demographics (such as age, gender, race or ethnicity)
• Past Medical History, Social History, Medications documented.
• Labs documented as SOC within 6mo of initial visit
• ABI with toe pressures2
• Wound debridement
• eKare wound measurement
• Hyperspectral Imaging
• Randomization
• Application of AmnioEXCEL+
• Source documentation
• Stipend disbursement

Visits 2 through 6:

• Wound debridement3
• eKare wound measurement4
• Hyperspectral imaging
• Application of AmnioEXCEL+ per cohort assignment
• Source documentation
• Stipend disbursement

Visit 7:

• Medications documented
• Wound debridement3
• eKare wound measurement4
• Hyperspectral imaging
• Application of AmnioEXCEL+ per cohort assignment
• Source documentation
• Stipend disbursement

Visits 8-11:

• Wound debridement3
• eKare wound measurement4
• Hyperspectral Imaging
• Application of AmnioEXCEL+ per cohort assignment
• Source documentation
• Stipend disbursement

Visit 12:

• Wound debridement3
• eKare wound measurement4
• Source documentation
• Stipend disbursement

End of Study (EOS) Visit 5:

• Medications documented
• Wound debridement3
• eKare wound measurement4
• Source documentation
• Subject exit from study

Criteria for Inclusion of Subjects:

• 21-90 years of age
• Able to provide informed consent
• Chronic foot ulceration below the ankle - persistent for >30 days but <6 months

Criteria for Exclusion of Subjects:

• <21 or >90 years of age
• Unable to provide informed consent
• History of poor compliance in the opinion of the investigator
• Gangrene
• Untreated osteomyelitis
• Widespread malignancy
• Active alcohol or substance abuse such as cocaine, heroin, or methamphetamines that in the opinion of the investigator will impact the subject's participation in the study
• Pregnancy