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

NCT02729688 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2018-08-17

No results posted yet for this study

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.

Conditions

  • Venous Insufficiency

Interventions

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.

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Nuttawut Sermsathanasawadi, MD · Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-03-01
Completion
2017-03-01

Countries

  • Thailand

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02729688 on ClinicalTrials.gov