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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Venous Insufficiency Device: customized pressure guide bandage Device: Ordinary elastic bandage Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of a Pressure Indicator Guided and a Conventional Bandaging in Treatment of Venous Leg Ulcer
Actual Study Start Date : March 2016
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : March 1, 2017

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Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Sub-bandage pressure [ Time Frame: 1 hour ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT02729688


Locations
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Thailand
Vascular Surgery, Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Nuttawut Sermsathanasawadi, MD Mahidol University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02729688    
Other Study ID Numbers: SIRIRAJ016/2559
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mahidol University:
Venous insufficiency
Compression
Bandaging
Additional relevant MeSH terms:
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Varicose Ulcer
Venous Insufficiency
Leg Ulcer
Skin Ulcer
 Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases