Characterization of AmnioExcel Plus in Two Treatment Paradigms

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Device: Amnio Excel + weekly; Device: Amnio Excel + max every 2 weeks

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center at Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Weekly AmnioEXCEL+ group; AmnioEXCEL+ will be applied weekly at study visits	Device: Amnio Excel + weekly; Amnio Excel + weekly
Active Comparator: 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)	Device: Amnio Excel + max every 2 weeks; Amnio Excel + max every 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Healed	Number of participants whose wounds healed during the study timeframe. Reported as dichotomous yes/no.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Volume	Wound volume measured by camera which performs a 3D measurement and calculates the volume at baseline	Baseline
Wound Area	Wound measured by camera which performs a 3D measurement and calculates the area at baseline	Baseline
Tissue Oxygenation (StO2) of the Dorsal Foot	Tissue oxygenation measured by hyperspectral imaging camera at baseline	Baseline

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Integra LifeSciences Corporation
• Investigators: Principal Investigator: Lawrence Lavery, DPM MPH, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2020
• Primary Completion (Actual): April 6, 2021
• Study Completion (Actual): April 6, 2021

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: January 16, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: 2019-1527

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes