Characterization of AmnioExcel Plus in Two Treatment Paradigms

The University of Texas System (UT)

Status: Completed

Conditions: Diabetic Foot Ulcer

Treatments: Device: Amnio Excel + max every 2 weeks; Device: Amnio Excel + weekly

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04233580

2019-1527

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 patients

Sex: All

Ages: 21 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Weekly AmnioEXCEL+ group

Active Comparator group

Description:

AmnioEXCEL+ will be applied weekly at study visits

Treatment:

Device: Amnio Excel + weekly

PRN AmnioEXCEL+ group

Active Comparator group

Description:

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)

Treatment:

Device: Amnio Excel + max every 2 weeks