Utilization of Compreflex Wraps in Patients With Chronic Venous Insuffciency

NCT05364112 | Unknown

• 1 other identifier: NMRR-21-330-58451
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicentre, quasi-experimental study to evaluate the Conformitè Europëenne-marked Compreflex standard calf and foot (with basic liner) under routine conditions. The study will be conducted at 4 clinics and will include 100 consecutive patients. Patients will be followed-up until 26 weeks.

Conditions

Varicose Ulcer; Venous Insufficiency of Leg

Keywords

Varicose Ulcer; Compression Bandages; Venous Insufficiency of Leg; Stockings, Compression

Outcome Measures

Primary Outcomes (1)

• Wound size

  Ulcer size will be measured by Measuring the length "head-to-toe" at the longest point. Measure the width side-to-side at the widest point that is perpendicular to the length. The inner border of the wound will be used for reference, both for length and width.

  26 months

Secondary Outcomes (1)

• Oedema volume

  26 months

Study Arms (1)

Compreflex

EXPERIMENTAL

Patients recruited for the study will be given one unit of Compreflex (study device) to be worn on the studied leg with a venous ulcer. Once the wound is covered by dressing, the subjects were instructed to wear the study device for 24 hours over the study period. Subjects were allowed to take off the study device during a shower. Subjects were asked to visit the clinic for follow-up purposes at 3 assessment time points after being recruited at the first visit: V2 (3-week), V3 (12-week) and V4 (26-week). Subjects' wound area, leg circumferences were measured and calculated. Patient-centred questionnaires were given to the subjects to assess their compliance and satisfaction with the study device.

Device: Compreflex

Interventions

Compreflex DEVICE

The Compreflex standard calf and foot (with basic liner) from Sigvaris (St. Gallen, Switzerland) is an easy-to-use interlacing Velcro wrap device with adjustable compression levels.

Compreflex

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are patients for whom it is medically indicated to use the device of interest in accordance with its instruction for use
• Are between 18 and 80 years old
• Have provided informed consent
• Are willing and able to participate in the follow-up examinations

You may not qualify if:

• Lymphoedema
• Presence of other comorbidities (i.e. congestive cardiac failure, renal failure, fulminant hepatic failure)
• Pregnancy
• Septicemia
• Infected chronic venous ulcer wound
• Ischemia (ABSI\<0.8)
• Noncompressible arteries (ABSI\<0.8)
• Bleeding tendencies

Sponsors & Collaborators

• Kuala Lumpur General Hospital: lead
• SULTAN AHMAD SHAH MEDICAL CENTRE @ IIUM: collaborator
• Universiti Kebangsaan Malaysia Medical Centre: collaborator
• University of Malaya: collaborator

Study Sites (1)

Wound Care Unit, Dept. of Internal Medicine, Kuala Lumpur Hospital

Kuala Lumpur, Malaysia

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Harikrishna R Nair

  Kuala Lumpur General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harikrishna R Nair

CONTACT

+60122920235; hulk25@hotmail.com

Xian Lew

CONTACT

+60192222445; jerinalew@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Wound Care Unit, Department of Medicine

Study Record Dates

• First Submitted: May 1, 2022
• First Posted: May 6, 2022
• Study Start: September 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)