Utilization of Compreflex Wraps in Patients With Chronic Venous Insuffciency

Utilization of Compreflex Wraps in Patients With Chronic Venous Insufficiency: A Quasiexperimental Post-market Clinical Follow-up Study

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.

Study Overview

• Status: Recruiting
• Conditions: Varicose Ulcer; Venous Insufficiency of Leg
• Intervention / Treatment: Device: Compreflex

Detailed Description

In chronic venous insufficiency (CVI), the venous system of the legs is ineffective in performing venous return, and there is venous reflux due to valve failure, physical inactivity and cardiovascular problems, leading to an increase in the pressure in the veins and venous hypertension. Chronic venous insufficiency includes a range of signs and symptoms, including varicose veins, varicose veins, oedema, skin lesions and ulcers.

Venous ulcers are wounds that occur due to improper functioning of venous valves secondary to severe chronic venous insufficiency. They are mainly located in the internal lateral zone of the distal third of the leg. Ulcers of venous aetiology make up 80% of all ulcers. They have an incidence of between 15 to 30 per 100'000 personyears.

The median healing time for chronic venous ulcers approximates 180 days. These ulcers may produce a foul-smelling discharge, can become infected and cause pain, which, in combination with slow healing and frequent relapses, affects the quality of life of affected patients.

The treatment of chronic venous ulcers requires a comprehensive approach for the patient, addressing the etiological factors that determine their evolution, such as venous insufficiency, diet, physical inactivity and postural measures. Local treatment has two components: local ulcer healing and control of venous insufficiency by means of compression therapy.

There is evidence that compression therapy promotes the healing process of venous ulcers. However, there is a large number of compression garments available and it is unclear which method of compression is the most effective. Traditionally, multilayered compression banding was the first line management for uncomplicated venous ulcers. This serves to increase venous return and reduce venous hypertension, as well as reduce oedema and improve lymphatic circulation. Despite its importance and widespread use, it has been reported that ca. 50% of patients do not comply with their multilevel bandaging. Reasons for non-compliance are skin irritation, bandage slippage, pain, malodor, inability to maintain hygiene, and discomfort and inability to wear normal footwear. Over recent years, there has been development of several Velcro-based wrap devices for use as alternative compression bandaging for venous ulcer management, using either interlacing or overlapping technique of wrapping. Systematic reviews have been undertaken for Velcro wrap devices, including their use in chronic edema, lipedema, and lymphedema, as well as venous ulceration. These systematic reviews were able to show a reduction in limb volume and more consistent sub-bandage pressure in Velcro wrap devices compared with bandaging. In addition, one of the major advantages that was reported was the relative ease to remove and reapply these devices, which can, therefore, encourage self-care, improve independence and, potentially, quality of life.

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.This Compreflex wrap is intended for patients with mild to moderate lymphedema and venous insufficiency. More than 200'000 products have been sold worldwide since 2016. The product is being used in many European countries (including United Kingdom, Switzerland, Netherland), United States of America, Saudi Arabia, India, Indonesia, Taiwan and Hong Kong, with no product-related safety issues reported. Although the product is not substantially different from other established products that are already available on the market, there are no clinical data published on Compreflex.

The present study was therefore designed to confirm the performance of the Compreflex standard calf and foot (with basic liner).

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Harikrishna R Nair; Phone Number: +60122920235; Email: hulk25@hotmail.com
• Study Contact Backup: Name: Xian Lew; Phone Number: +60192222445; Email: jerinalew@gmail.com

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia
    • Recruiting
    • Wound Care Unit, Dept. of Internal Medicine, Kuala Lumpur Hospital
    • Contact: Karina Koh, MD; Phone Number: 1783 +6-03-2615 5555; Email: karinakoh@crc.moh.gov.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Compreflex; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oedema volume	Limb circumference measurement will be performed as indicated in the figure below, with: 00: level of ground; 0: tip of great toe; C1: base of metatarsophalangeal joints; C2: 10 cm from 0; C3: midtarsal line through most proximal part of dorsum of foot; C4: line through midpoint of lateral malleolus; C5: 12 cm from 00; C6: 20 cm from 00; C7: 30 cm from 00; L1: length from 0 to C3; L2: length from 00 to C4; L3: length from C4 to C7. Volume of edema will then be estimated as follows:	26 months

Collaborators and Investigators

• Sponsor: Kuala Lumpur General Hospital
• Collaborators: University of Malaya; Universiti Kebangsaan Malaysia Medical Centre; SULTAN AHMAD SHAH MEDICAL CENTRE @ IIUM
• Investigators: Principal Investigator: Harikrishna R Nair, Kuala Lumpur General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: May 1, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 22, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Compression Bandages; Varicose Ulcer; Venous Insufficiency of Leg; Stockings, Compression
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Varicose Veins; Varicose Ulcer; Venous Insufficiency
• Other Study ID Numbers: NMRR-21-330-58451

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No