Characterization of AmnioExcel Plus in Two Treatment Paradigms

NCT ID: NCT04233580

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-09
• Study Completion Date: 2021-04-06

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

Conditions

Diabetic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Weekly AmnioEXCEL+ group

AmnioEXCEL+ will be applied weekly at study visits

Group Type: ACTIVE_COMPARATOR

Amnio Excel + weekly

Intervention Type: DEVICE

Amnio Excel + weekly

PRN AmnioEXCEL+ group

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)

Group Type: ACTIVE_COMPARATOR

Amnio Excel + max every 2 weeks

Intervention Type: DEVICE

Amnio Excel + max every 2 weeks

Interventions

Amnio Excel + weekly

Amnio Excel + weekly

Intervention Type: DEVICE

Amnio Excel + max every 2 weeks

Amnio Excel + max every 2 weeks

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Integra LifeSciences Corporation

INDUSTRY

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Larry Lavery

Professor and Director of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lawrence Lavery, DPM MPH

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

UT Southwestern Medical Center at Dallas

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2019-1527

Identifier Type: -

Identifier Source: org_study_id