Characterization of AmnioExcel Plus in Two Treatment Paradigms

Diabetic Foot Ulcer Clinical Trial

Official title:

Characterization of AmnioExcel Plus in Two Treatment Paradigms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04233580
• Other study ID #: 2019-1527
• Status: Completed
• Phase: N/A
• Start date: July 9, 2020
• Est. completion date: April 6, 2021

Study information

• Verified date: July 2023
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 6, 2021
• Est. primary completion date: April 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer

Intervention

Device:
• Amnio Excel + weekly
Amnio Excel + weekly
• Amnio Excel + max every 2 weeks
Amnio Excel + max every 2 weeks

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center at Dallas	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Healed	Number of participants whose wounds healed during the study timeframe. Reported as dichotomous yes/no.	12 weeks
Secondary	Wound Volume	Wound volume measured by camera which performs a 3D measurement and calculates the volume at baseline	Baseline
Secondary	Wound Area	Wound measured by camera which performs a 3D measurement and calculates the area at baseline	Baseline
Secondary	Tissue Oxygenation (StO2) of the Dorsal Foot	Tissue oxygenation measured by hyperspectral imaging camera at baseline	Baseline