Unna Boots for Ankle Fracture Swelling

NCT04086927 | Withdrawn

• 1 other identifier: 00092143
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ankle Fractures

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline (Initial encounter)

• 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.

  6 weeks follow up visit

• 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

  Baseline (initial encounter)

• 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

  6 weeks follow up visit

Study Arms (2)

Control Group

NO INTERVENTION

Patients will not receive compression dressing

Experimental Group

EXPERIMENTAL

Patients will receive compression dressing

Device: Unna Boot

Interventions

Unna Boot DEVICE

The unna boot is a zinc coated compression dressing

Experimental Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• acute ankle fracture

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of South Carolina: lead

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Study Officials

• Christopher E Gross, M.D.

  Orthopaedic Surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 12, 2019
• Study Start: January 31, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09