Characterization of AmnioExcel Plus in Two Treatment Paradigms
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2020
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedStudy Start
First participant enrolled
July 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 6, 2021
CompletedResults Posted
Study results publicly available
September 22, 2022
CompletedJuly 24, 2023
July 1, 2023
9 months
January 14, 2020
May 31, 2022
July 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Healed
Number of participants whose wounds healed during the study timeframe. Reported as dichotomous yes/no.
12 weeks
Secondary Outcomes (3)
Wound Volume
Baseline
Wound Area
Baseline
Tissue Oxygenation (StO2) of the Dorsal Foot
Baseline
Study Arms (2)
Weekly AmnioEXCEL+ group
ACTIVE COMPARATORAmnioEXCEL+ will be applied weekly at study visits
PRN AmnioEXCEL+ group
ACTIVE COMPARATORAmnioEXCEL+ 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)
Interventions
Eligibility Criteria
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Sponsors & Collaborators
Study Sites (1)
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Enrollment was limited due to Covid-19 pandemic. Occasional missed visits occurred when patients were quarantined and not allowed to present to clinic.
Results Point of Contact
- Title
- Tara Kristof
- Organization
- University of Texas Southwestern Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Lawrence Lavery, DPM MPH
University of Texas Southwestern Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Director of Research
Study Record Dates
First Submitted
January 14, 2020
First Posted
January 18, 2020
Study Start
July 9, 2020
Primary Completion
April 6, 2021
Study Completion
April 6, 2021
Last Updated
July 24, 2023
Results First Posted
September 22, 2022
Record last verified: 2023-07