Unna Boots for Ankle Fracture Swelling
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04086927 |
Recruitment Status :
Withdrawn
(no funding)
First Posted : September 12, 2019
Last Update Posted : January 12, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ankle Fractures | Device: Unna Boot | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Unna Boot: A Technique to Decrease Preoperative Soft Tissue Swelling Following Ankle Fractures |
Estimated Study Start Date : | January 31, 2021 |
Estimated Primary Completion Date : | January 1, 2022 |
Estimated Study Completion Date : | January 1, 2022 |

Arm | Intervention/treatment |
---|---|
No Intervention: Control Group
Patients will not receive compression dressing
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Experimental: Experimental Group
Patients will receive compression dressing
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Device: Unna Boot
The unna boot is a zinc coated compression dressing |
- Baseline swelling using Figure-8 Measurement [ Time Frame: Baseline (Initial encounter) ]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 [ Time Frame: 6 weeks follow up visit ]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 [ Time Frame: Baseline (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 [ Time Frame: 6 weeks follow up visit ]patients report a pain score of 1-10. 1 being the lowest and 10 being the highest

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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- acute ankle fracture
Exclusion Criteria:
- low energy ankle fracture
- open ankle fracture
- unwillingness to participate
- allergy to zinc
- revision surgery

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): NCT04086927
Principal Investigator: | Christopher E Gross, M.D. | Orthopaedic Surgeon |
Responsible Party: | Medical University of South Carolina |
ClinicalTrials.gov Identifier: | NCT04086927 |
Other Study ID Numbers: |
00092143 |
First Posted: | September 12, 2019 Key Record Dates |
Last Update Posted: | January 12, 2021 |
Last Verified: | January 2021 |
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 |
Fractures, Bone Ankle Fractures Wounds and Injuries |