Characterization of AmnioExcel Plus in Two Treatment Paradigms
- Conditions
- Diabetic Foot Ulcer
- Interventions
- Device: Amnio Excel + weeklyDevice: Amnio Excel + max every 2 weeks
- Registration Number
- NCT04233580
- Lead Sponsor
- University of Texas Southwestern Medical Center
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Weekly AmnioEXCEL+ group Amnio Excel + weekly AmnioEXCEL+ will be applied weekly at study visits PRN AmnioEXCEL+ group Amnio Excel + max every 2 weeks 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)
- Primary Outcome Measures
Name Time Method Number of Participants Who Healed 12 weeks Number of participants whose wounds healed during the study timeframe. Reported as dichotomous yes/no.
- Secondary Outcome Measures
Name Time Method Wound Volume Baseline Wound volume measured by camera which performs a 3D measurement and calculates the volume at baseline
Wound Area Baseline Wound measured by camera which performs a 3D measurement and calculates the area at baseline
Tissue Oxygenation (StO2) of the Dorsal Foot Baseline Tissue oxygenation measured by hyperspectral imaging camera at baseline
Trial Locations
- Locations (1)
UT Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States