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

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

Tracking Information

• First Submitted Date: March 25, 2016
• First Posted Date: April 6, 2016
• Last Update Posted Date: August 17, 2018
• Actual Study Start Date: March 2016
• Actual Primary Completion Date: March 1, 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 27, 2016): Sub-bandage pressure [ Time Frame: 1 hour ]
• Original Primary Outcome Measures (submitted: March 31, 2016): Sub-bandage pressure [ Time Frame: 1 year ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effectiveness of a Pressure Indicator Guided and a Conventional Bandaging in Treatment of Venous Leg Ulcer
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Venous Insufficiency

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 31, 2016): 90
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 1, 2017
• Actual Primary Completion Date: March 1, 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Thailand

Administrative Information

• NCT Number: NCT02729688
• Other Study ID Numbers: SIRIRAJ016/2559
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Mahidol University
• Study Sponsor: Mahidol University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Nuttawut Sermsathanasawadi, MD; Mahidol University

• PRS Account: Mahidol University
• Verification Date: August 2018