Characterization of AmnioExcel Plus in Two Treatment Paradigms

Study Overview
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Brief Summary
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The Investigators plan to evaluate healing in two cohorts of patients with diabetic foot wounds (n=20) that receive optimal treatment including serial wound debridement and off-loading with a boot or postop shoe and AmnioEXCEL+. In one cohort, AmnioEXCEL+ will be applied weekly at study visits and in the second cohort, AmnioEXCEL+ will be applied maximum every 2 weeks (PRN, in the case that the wound requires debridement at a visit not intended for AE+ application, the wound will be treated as SOC). In addition, the Investigators will collect data on other potential confounding factors that could affect healing such as antibiotic, anti-fungal and anti-infective medications, tobacco, comorbidities, diabetes control, infection, perfusion, and activity. Wound healing, including wound size and adverse events will be evaluated.

Detailed Description
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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

Official Title
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Characterization of AmnioExcel Plus in Two Treatment Paradigms

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: Amnio Excel + weekly
* Device: Amnio Excel + max every 2 weeks


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Weekly AmnioEXCEL+ group<br>AmnioEXCEL+ will be applied weekly at study visits | Device: Amnio Excel + weekly<br>* Amnio Excel + weekly<br>|
| Active Comparator: PRN AmnioEXCEL+ group<br>AmnioEXCEL+ will be applied maximum every 2 weeks (PRN, in the case that the wound requires debridement at a visit not intended for AE+ application, the wound will be treated as SOC) | Device: Amnio Excel + max every 2 weeks<br>* Amnio Excel + max every 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Healed | Number of participants whose wounds healed during the study timeframe. Reported as dichotomous yes/no. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Volume | Wound volume measured by camera which performs a 3D measurement and calculates the volume at baseline | Baseline | 
| Wound Area | Wound measured by camera which performs a 3D measurement and calculates the area at baseline | Baseline | 
| Tissue Oxygenation (StO2) of the Dorsal Foot | Tissue oxygenation measured by hyperspectral imaging camera at baseline | Baseline |