Clinical trial NCT04233580: Characterization of AmnioExcel Plus in Two Treatment Paradigms
Official title: Characterization of AmnioExcel Plus in Two Treatment Paradigms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Integra LifeSciences Corporation
First posted: 2020-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility 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

Primary outcomes:
measure: Number of Participants Who Healed
timeFrame: 12 weeks
Secondary outcomes:
measure: Wound Volume
timeFrame: Baseline
measure: Wound Area
timeFrame: Baseline
measure: Tissue Oxygenation (StO2) of the Dorsal Foot
timeFrame: Baseline
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Lawrence Lavery, DPM MPH
role: PRINCIPAL_INVESTIGATOR
References: