NCT04233580

Characterization of AmnioExcel Plus in Two Treatment Paradigms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	Amnio Excel + weekly	Amnio Excel + weekly
DEVICE	Amnio Excel + max every 2 weeks	Amnio Excel + max every 2 weeks

Timeline

• Start date: 2020-07-09
• Primary completion: 2021-04-06
• Completion: 2021-04-06
• First posted: 2020-01-18
• Last updated: 2023-07-24
• Results posted: 2022-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study