Utilization of Compreflex Wraps in Patients With Chronic Venous Insuffciency
Varicose Ulcer, Venous Insufficiency of Leg
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
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
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.