Status:
UNKNOWN
Utilization of Compreflex Wraps in Patients With Chronic Venous Insuffciency
Lead Sponsor:
Kuala Lumpur General Hospital
Collaborating Sponsors:
SULTAN AHMAD SHAH MEDICAL CENTRE @ IIUM
Universiti Kebangsaan Malaysia Medical Centre
Conditions:
Varicose Ulcer
Venous Insufficiency of Leg
Eligibility:
All Genders
18-80 years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05364112
Start Date
September 1 2021
End Date
December 31 2022
Last Update
October 25 2022
Active Locations (1)
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1
Wound Care Unit, Dept. of Internal Medicine, Kuala Lumpur Hospital
Kuala Lumpur, Malaysia