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

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.

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Key information

Conditions

Venous Insufficiency Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vascular Surgery, Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

customized pressure guide bandage

Device

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.

Ordinary elastic bandage

Device

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.

Primary outcomes

Sub-bandage pressure

Time frame: 1 hour

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Apr 6, 2016
Registry last updated: Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed