RECRUITING
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Aerofit Post Market Investigation
The goal of this clinical investigation is to evaluate the clinical benefits of a ventilating suspension interface for individuals with transfemoral amputation. The main aim of the investigation will be to evaluate the clinical user-reported benefits to skin health from using a ventilating lower limb prosthetic suspension system and compare it to a non-ventilating suspension system.
Conditions:
🦠 Transfemoral Amputation 🦠 Amputation 🦠 Skin Health
🗓️ Study Start (Actual) 6 June 2023
🗓️ Primary Completion (Estimated) 30 May 2024
✅ Study Completion (Estimated) 30 May 2024
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Gainesville, Florida, United States
📍 Indianapolis, Indiana, United States
📍 Indianapolis, Indiana, United States
📍 Bay City, Michigan, United States
📍 Perrysburg, Ohio, United States
📍 Arlington, Texas, United States
📍 Virginia Beach, Virginia, United States
More locations available...

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 50Kg\< body weight \< 136Kg
    • * Cognitive ability to understand all instructions and questionnaires in the study
    • * Intended for unilateral/bilateral individuals that fit the indications for use, fit within the specified criteria and with the limb length, shape and ability to use a prosthetic liner: Activity level: K1 - K4, Impact level: Low to high, Amputation level: transfemoral
    • * Congenital transverse deficiency at femoral level
    • * Using Seal-In Silicone Liner and Direct Socket or AeroFit Seal-In Liner and AeroFit Socket
    • * Able to use AeroFit Solution, see Figure 7 AeroFit Seal-In Liner Sizes and Figure 8 Minimum socket height per liner profile.
    • * Residual limb profile: Standard or conical
    • * Willing and able to participate in the study and follow the protocol
    • * Confident (all day) prosthetic users for more than 3 months
    • * Older than 18 years

    Exclusion Criteria:

    • * Participating in another research study that may affect the participation or results of this study (in the opinion of the investigator)
    • * Users that have received Botox injection as treatment for residual limb sweat issue in the last 4 months
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 31 May 2023
  • First Submitted that Met QC Criteria 27 June 2023
  • First Posted 29 June 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 23 November 2023
  • Last Update Posted 27 November 2023
  • Last Verified November 2023
I'm interested ...!!