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Utilization of Compreflex Wraps in Patients With Chronic Venous Insuffciency

Primary Purpose

Varicose Ulcer, Venous Insufficiency of Leg

Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Compreflex
Sponsored by
Kuala Lumpur General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Ulcer focused on measuring Varicose Ulcer, Compression Bandages, Venous Insufficiency of Leg, Stockings, Compression

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Wound Care Unit, Dept. of Internal Medicine, Kuala Lumpur HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Compreflex

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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:

Full Information

First Posted
May 1, 2022
Last Updated
October 22, 2022
Sponsor
Kuala Lumpur General Hospital
Collaborators
SULTAN AHMAD SHAH MEDICAL CENTRE @ IIUM, Universiti Kebangsaan Malaysia Medical Centre, University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT05364112
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuala Lumpur General Hospital
Collaborators
SULTAN AHMAD SHAH MEDICAL CENTRE @ IIUM, Universiti Kebangsaan Malaysia Medical Centre, University of Malaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Ulcer, Venous Insufficiency of Leg
Keywords
Varicose Ulcer, Compression Bandages, Venous Insufficiency of Leg, Stockings, Compression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Compreflex
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Compreflex
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wound size
Description
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.
Time Frame
26 months
Secondary Outcome Measure Information:
Title
Oedema volume
Description
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:
Time Frame
26 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Harikrishna R Nair
Phone
+60122920235
Email
hulk25@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xian Lew
Phone
+60192222445
Email
jerinalew@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harikrishna R Nair
Organizational Affiliation
Kuala Lumpur General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wound Care Unit, Dept. of Internal Medicine, Kuala Lumpur Hospital
City
Kuala Lumpur
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karina Koh, MD
Phone
+6-03-2615 5555
Ext
1783
Email
karinakoh@crc.moh.gov.my

12. IPD Sharing Statement

Plan to Share IPD
No

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Utilization of Compreflex Wraps in Patients With Chronic Venous Insuffciency

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