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Characterization of AmnioExcel Plus in Two Treatment Paradigms

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ClinicalTrials.gov Identifier: NCT04233580
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : July 13, 2020
Sponsor:
Collaborator:
Integra
Information provided by (Responsible Party):
Larry Lavery, 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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Device: Amnio Excel + weekly Device: Amnio Excel + max every 2 weeks Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Characterization of AmnioExcel Plus in Two Treatment Paradigms
Actual Study Start Date : July 9, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2022


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




Primary Outcome Measures :
  1. Ekare wound measurement application to track wound healing. [ Time Frame: 12 weeks ]
    Incidence of healing at 12 weeks, tracked by wound measuring camera/app which performs a 3D measurement. This tracks rate of healing.


Secondary Outcome Measures :
  1. Ekare wound measurement application to track wound percent volume reduction [ Time Frame: 12 weeks ]
    Percent of volume reduction at 12 weeks, tracked by wound measuring camera/app which performs a 3D measurement and calculates the volume.

  2. Ekare wound measurement application to track wound percent area reduction [ Time Frame: 12 weeks ]
    Percent of area reduction at 12 weeks, tracked by wound measuring camera/app which performs a 3D measurement and calculates the area.

  3. Hyperspectral imaging camera to track wound bed perfusion. [ Time Frame: 12 weeks ]
    Hyperspectral imaging camera is used to track wound bed perfusion by calculating oxygenation and deoxygenation of the wound bed.



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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04233580


Contacts
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Contact: Tara Kristof 214-648-8602 tara.kristof@utsouthwestern.edu
Contact: Debby Noble 214-648-8686 debby.noble@utsouthwestern.edu

Locations
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United States, Texas
UT Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Tara Kristof    214-648-9007    Tara.Kristof@UTSouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Integra
Investigators
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Principal Investigator: Lawrence Lavery, DPM MPH UT Southwestern Medical Center
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Responsible Party: Larry Lavery, Professor and Director of Research, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04233580    
Other Study ID Numbers: 2019-1527
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: July 13, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents