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Characterization of AmnioExcel Plus in Two Treatment Paradigms

NCT04233580 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-07-24

Study results available
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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.

Conditions

  • Diabetic Foot Ulcer

Interventions

DEVICE

Amnio Excel + weekly

Amnio Excel + weekly

DEVICE

Amnio Excel + max every 2 weeks

Amnio Excel + max every 2 weeks

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    collaborator INDUSTRY

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Lawrence Lavery, DPM MPH · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-09
Primary Completion
2021-04-06
Completion
2021-04-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04233580 on ClinicalTrials.gov