Clinical trial NCT05364112: Utilization of Compreflex Wraps in Patients With Chronic Venous Insuffciency
Official title: Utilization of Compreflex Wraps in Patients With Chronic Venous Insufficiency: A Quasiexperimental Post-market Clinical Follow-up Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Varicose Ulcer
Venous Insufficiency of Leg
Keywords: Varicose Ulcer
Compression Bandages
Venous Insufficiency of Leg
Stockings, Compression
Lead sponsor: Kuala Lumpur General Hospital
Sponsor class: OTHER_GOV
Collaborators: name: SULTAN AHMAD SHAH MEDICAL CENTRE @ IIUM
name: Universiti Kebangsaan Malaysia Medical Centre
name: University of Malaya
First posted: 2022-05-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Wound size
timeFrame: 26 months
Secondary outcomes:
measure: Oedema volume
timeFrame: 26 months
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Wound Care Unit, Dept. of Internal Medicine, Kuala Lumpur Hospital
Study officials:
affiliation: Kuala Lumpur General Hospital
name: Harikrishna R Nair
role: PRINCIPAL_INVESTIGATOR
References: