None listed
Conditions
Brief summary
Venous disease is the most common cause of leg ulcers. The refractory nature of venous ulcers affects the quality of life and work productivity of those persons afflicted. This, in combination with the high costs of long-term therapy, makes venous ulcers a major health problem in developed countries. Management of venous leg ulcers is based on understanding pathophysiologic abnormalities. In recent years, identifying prognostic factors for healing and developing novel therapeutic approaches for venous ulcers have offered valuable tools for the management of patients with this disorder. Compression increases ulcer healing rates compared with no compression. Multi-layered systems are more effective than single-layered systems. High compression is more effective than low compression but there are no clear differences in the effectiveness of different types of high compression(1). The aim of this study is to evaluate the efficacy and safety of graduated three layer straight tubular bandaging when compared to 4 layer compression bandaging in healing venous ulcers in patients with chronic venous ulceration.
Interventions
graduated three layer straight tubular bandaging system which consists of an elastic tubular bandage that is often used as a support bandage.
In this study the investigational product will be used in graduated lengths of 3 layers of the tubular bandage system as follows:
1. from base of toes to just under knee (long layer)
2. from base of toes to above calf pump (medium layer)
3. from base of toes to mid gaiter (short layer)
participants will be bandaged weekly for 12 weeks and will keep this
graduated three layer straight tubular bandaging system which consists of an elastic tubular bandage that is often used as a support bandage. In this study the investigational product will be used in graduated lengths of 3 layers of the tubular bandage system as follows: 1. from base of toes to just under knee (long layer) 2. from base of toes to above calf pump (medium layer) 3. from base of toes to mid gaiter (short layer) participants will be bandaged weekly for 12 weeks and will keep this bandage on between treatment visits.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Male and female study participants who meet all of the following criteria can be entered into the study: 1. Presence of a venous ulcer that is confirmed by Clinical signs, Etiologic classification, Anatomical distribution and Pathological dysfunction (CEAP) assessment to be the result of chronic venous insufficiency. 2. Aged over 18 years. 3. Present with clinical evidence of chronic venous insufficiency and chronic venous ulceration as evidenced by one or more of the following: i. lower limb pigmentation, ii. varicose eczema, iii. lipodermatosclerosis, iv. varicose veins. 4. Chronic venous leg ulcer (target ulcer) that i. Has been present for at least 4 weeks ii. is of an area equal to or greater than 1 cm2 but less than or equal to 20 cm2 as measured by digital planimetry techniques, 5. Ankle Brachial Pressure index of equal or greater than 0.8 mmHg. 6. Ankle circumference of greater than 18 cm and less than 25 cm 7. Mobile, and able to return for required treatments and study evaluations without undue hardship. 8. Able to give Informed Consent. 9. Able to understand and comply with the requirements of the trial.
Exclusion criteria
Study participants who meet any of the following criteria will not be eligible for participation in this study: 1. Unable or unwilling to wear compression bandage as directed. 2. Allergy to any of the trial products used. 3. Immobility. 4. Participation in any other clinical trial or exposure to an investigational drug within 30 days of study enrolment. 5. Evidence of severe liver disease, cardiac disease or chronic pulmonary disease. 6. Medical condition likely to require systemic corticosteroids during the study period. 7. Any significant condition that may preclude the participant from the study (e.g. severe depression or psychiatric illness). 8. Clinically documented thrombo-phlebitis or suspected deep vein thrombosis. 9. Unable or unwilling to attend clinic for weekly treatment 10. Participation in this trial previously and/or who dropped out or were withdrawn.
Outcome results
None listed