Characterization of AmnioExcel Plus in Two Treatment Paradigms
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer
Study type: Interventional

Summary: 
      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: 
      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

        1. Only collect antibiotics, anti-fungal and anti-infective medications.

        2. ABI (with toe pressure) can be done at screening or baseline.

        3. Once wound is healed, wound debridement will not be done at weekly visits.

        4. Once wound is healed, eKare will not be done at weekly visits.

        5. 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
    

Intervention name(s): Amnio Excel + weekly; Amnio Excel + max every 2 weeks
Intervention type(s): Device; Device
Intervention description(s): Amnio Excel + weekly; Amnio Excel + max every 2 weeks
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment