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Unna Boots for Ankle Fracture Swelling

Primary Purpose

Ankle Fractures

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Unna Boot
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Fractures

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • acute ankle fracture

Exclusion Criteria:

  • low energy ankle fracture
  • open ankle fracture
  • unwillingness to participate
  • allergy to zinc
  • revision surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control Group

    Experimental Group

    Arm Description

    Patients will not receive compression dressing

    Patients will receive compression dressing

    Outcomes

    Primary Outcome Measures

    Baseline swelling using Figure-8 Measurement
    Physician uses tape measure to measure angles to determine swelling severity of ankle. This measurement is taken by making a figure eight pattern on the foot and ankle. The measurement is taken three times and then averaged to give the final total.
    Mean swelling using Figure-8 Measurement
    Physician uses tape measure to measure angles to determine swelling severity of ankle. This measurement is taken by making a figure eight pattern on the foot and ankle. The measurement is taken three times and then averaged to give the final total.
    Mean pain scores on visual analogue scale at initial encounter
    patients report a pain score of 1-10. 1 being the lowest and 10 being the highest
    Mean pain scores on visual analogue scale at 6 week follow up visit
    patients report a pain score of 1-10. 1 being the lowest and 10 being the highest

    Secondary Outcome Measures

    Full Information

    First Posted
    September 10, 2019
    Last Updated
    January 8, 2021
    Sponsor
    Medical University of South Carolina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04086927
    Brief Title
    Unna Boots for Ankle Fracture Swelling
    Official Title
    Unna Boot: A Technique to Decrease Preoperative Soft Tissue Swelling Following Ankle Fractures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    no funding
    Study Start Date
    January 31, 2021 (Anticipated)
    Primary Completion Date
    January 1, 2022 (Anticipated)
    Study Completion Date
    January 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medical University of South Carolina

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will evaluate the difference in soft tissue swelling prior to surgery and wound complications after surgery between unna boot application versus standard splint application. An unna boot is an extra zinc covered wrap around your leg followed by standard splint application (cotton dressing, plaster, then soft dressing). Prior to surgery the participant's swelling will be measured and compared to the standard splint application group. After surgery, the participant will be monitored for wound complications, pain, and range of motion.
    Detailed Description
    The purpose of this study is to compare preoperative swelling and frequency of wound complications in ankle fractures through standard splint and an unna boot compressive dressing with a splint. Quantitative and qualitative measurements will be analyzed to compare edema and wound complications. Secondary goals are to evaluate the quantitative differences in ankle range of motion and visual analogue scale (VAS) pain scores. The hypothesis of this proposed study is that there will be less soft tissue swelling and wound complications with the use of an unna boot when compared to the standard splint. The investigators also hypothesize that there will be improved ankle range of motion and visual analogue scale (VAS) pain scores with the use of an unna boot when compared to a standard splint. Participants will be randomized to either the standard splint or an unna boot and quantitative and qualitative measures will be collected. This data could change the practice for preoperative management of soft tissue swelling following ankle fractures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ankle Fractures

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Patients will not receive compression dressing
    Arm Title
    Experimental Group
    Arm Type
    Experimental
    Arm Description
    Patients will receive compression dressing
    Intervention Type
    Device
    Intervention Name(s)
    Unna Boot
    Intervention Description
    The unna boot is a zinc coated compression dressing
    Primary Outcome Measure Information:
    Title
    Baseline swelling using Figure-8 Measurement
    Description
    Physician uses tape measure to measure angles to determine swelling severity of ankle. This measurement is taken by making a figure eight pattern on the foot and ankle. The measurement is taken three times and then averaged to give the final total.
    Time Frame
    Baseline (Initial encounter)
    Title
    Mean swelling using Figure-8 Measurement
    Description
    Physician uses tape measure to measure angles to determine swelling severity of ankle. This measurement is taken by making a figure eight pattern on the foot and ankle. The measurement is taken three times and then averaged to give the final total.
    Time Frame
    6 weeks follow up visit
    Title
    Mean pain scores on visual analogue scale at initial encounter
    Description
    patients report a pain score of 1-10. 1 being the lowest and 10 being the highest
    Time Frame
    Baseline (initial encounter)
    Title
    Mean pain scores on visual analogue scale at 6 week follow up visit
    Description
    patients report a pain score of 1-10. 1 being the lowest and 10 being the highest
    Time Frame
    6 weeks follow up visit

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: acute ankle fracture Exclusion Criteria: low energy ankle fracture open ankle fracture unwillingness to participate allergy to zinc revision surgery
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christopher E Gross, M.D.
    Organizational Affiliation
    Orthopaedic Surgeon
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Unna Boots for Ankle Fracture Swelling

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