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Effectiveness of a Pressure Indicator Guided and a Conventional Bandaging in Treatment of Venous Leg Ulcer

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ClinicalTrials.gov Identifier: NCT02729688
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Tracking Information
First Submitted Date  ICMJE March 25, 2016
First Posted Date  ICMJE April 6, 2016
Last Update Posted Date August 17, 2018
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date March 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2016)
Sub-bandage pressure [ Time Frame: 1 hour ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 31, 2016)
Sub-bandage pressure [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of a Pressure Indicator Guided and a Conventional Bandaging in Treatment of Venous Leg Ulcer
Official Title  ICMJE Effectiveness of a Pressure Indicator Guided and a Conventional Bandaging in Treatment of Venous Leg Ulcer
Brief Summary Objective of this study are to compare the interface pressure by applying ordinary elastic bandage (OEB) and CPG-EB. In addition, investigators compared the percentage of patients who could apply the optimal pressure with OEB and CPG-EB.
Detailed Description

For treatment of venous ulcer, it was shown that compression bandaging of 35-45 mmHg sub-bandage pressure at the ankle was shown in several studies to be safe and effective.The efficacy of compression bandage considerably depends on the applied pressure and it is therefore largely dependent on the individual applying bandages. The lower pressure leads to treatment failure while the higher pressure leads to skin complication.

The use of objective devices to proof that the bandage is sufficiently applied is not available for every patients. To help the patients to apply the bandage with optimal pressure, investigators developed the customized pressure guide elastic bandage (CPG-EB) by using sub-bandage pressure guidance.

Objective of this study are to compare the interface pressure by applying ordinary elastic bandage (OEB) and CPG-EB. In addition,investigators compared the percentage of inexperienced staffs who could apply the optimal pressure with OEB and CPG-EB.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Venous Insufficiency
Intervention  ICMJE
  • Device: customized pressure guide bandage

    Investigators developed the customized pressure guide elastic bandage (CPG-EB). The experienced nurse applied the elastic bandages to each patient with sub bandage pressure monitoring. The target pressure was 35-45 mmHg. Measurements of the pressure applied by bandages was performed at point B1 corresponding to the height where the Achilles' tendon turns into the gastrocnemius muscle with Picopress (MicroLAB Elettronica, Ponte S. Nicolo, Italy). If the target pressure 35-45 mmHg was achieved, the circular ink stamp was applied into the entire bandages. The markers in CPG-EB had elliptical shape when they were not stretched. They turned into circular shape when they were stretched.

    For the OEB, Bandaging was applied by spiral methods. Three EB were applied with 50 % stretching and 50% overlapping from foot to just below knee level.

  • Device: Ordinary elastic bandage
    Bandaging was applied by spiral methods. Three ordinary elastic bandages were applied with 50 % stretching and 50% overlapping from foot to just below knee level.
Study Arms  ICMJE
  • Active Comparator: ordinary elastic bandage
    Bandaging was applied by spiral methods. Three ordinary elastic bandages were applied with 50 % stretching and 50% overlapping from foot to just below knee level.
    Intervention: Device: Ordinary elastic bandage
  • Active Comparator: customized pressure guide bandage
    Bandaging was applied by spiral methods. Three customized pressure guide elastic bandage were applied by stretching until the elliptical shape marker in the bandage turned into circular shape with 50% overlapping from foot to just below knee level.
    Intervention: Device: customized pressure guide bandage
Publications * Sermsathanasawadi N, Tarapongpun T, Pianchareonsin R, Puangpunngam N, Wongwanit C, Chinsakchai K, Mutirangura P, Ruangsetakit C. Customizing elastic pressure bandages for reuse to a predetermined, sub-bandage pressure: A randomized controlled trial. Phlebology. 2018 Oct;33(9):627-635. doi: 10.1177/0268355517746434. Epub 2017 Dec 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2016)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 1, 2017
Actual Primary Completion Date March 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with chronic venous insufficiency CEAP (clinical, etiologic, anatomic, and pathophysiologic) C4,C5 and C6

Exclusion Criteria:

  • Patients who can not perform bandaging by themselves
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02729688
Other Study ID Numbers  ICMJE SIRIRAJ016/2559
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mahidol University
Study Sponsor  ICMJE Mahidol University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nuttawut Sermsathanasawadi, MD Mahidol University
PRS Account Mahidol University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP