Utilization of Compreflex Wraps in Patients With Chronic Venous Insuffciency

Sponsor

Kuala Lumpur General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05364112

Collaborator

SULTAN AHMAD SHAH MEDICAL CENTRE @ IIUM (Other), Universiti Kebangsaan Malaysia Medical Centre (Other), University of Malaya (Other)

100

Enrollment

Location

Arm

8.9

Anticipated Duration (Months)

11.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Varicose Ulcer Venous Insufficiency of Leg	Device: Compreflex	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

May 31, 2022

Anticipated Study Completion Date :

May 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Wound size [26 months]
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.

Secondary Outcome Measures

Oedema volume [26 months]
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:

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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