Varicose Ulcer
Conditions
Keywords
Varicose ulcer, Compression Therapy, Negative Pressure, Vacuum Assisted Closure
Brief summary
This study randomises patients with venous leg ulcers, to be managed either using conventional compression bandages or a bridged vacuum assisted closure system under compression.
Detailed description
Venous ulcers are characterised by a cyclical pattern of healing and recurrence, with recurrence rates between 45 and 70% at one year. Venous leg ulceration has been identified as a common source of morbidity and reduced quality of life, especially in the elderly population. Non-healing ulcers place the patient at a much higher risk for lower extremity amputation. Compression therapy is currently recognised as the main treatment for venous leg ulcers. External compression is applied as a therapy for venous leg ulcers, in an attempt to reverse the increased hydrostatic pressure in the veins. The application of negative pressure to successfully treat and aid in the healing of open wounds has been studied extensively for decades, demonstrating favourable clinical results. However, there is a lack of evidence in the literature regarding the use of VAC in venous ulcers. The combination of negative pressure therapy and compression therapy is theorized to provide the benefits of both individual therapies. As such, the utilization of the Bridge VAC under a compression dressing is expected to expedite the healing of venous ulcers. The investigators aim to randomise patients with venous ulcers to either be managed using conventional compression dressings or combined bridge vacuum assisted closure with compression dressings.
Interventions
DEVICEBridged V.A.C.® with compression therapy
Patients randomised to receive Bridge VAC with compression dressings will be managed using ActiV.A.C. Therapy unit, with a continuous pressure of 125mmHg. A V.A.C.® Granufoam™ Bridge Dressing will be used instead of the tube connector. A Coban™ Lite compression dressing will be placed over the VAC dressing. The Bridge connector of the VAC will be used to tunnel underneath the Coban™ Lite till the upper edge of the dressing.
DEVICEConventional Compression Therapy
Patients randomised to receive compression dressings will be managed using Coban™ Lite compression dressings with underlying non-adherent wound contact layer (WCL) dressings. Under the supervision of the investigating clinician, the dressings will be applied by a wound care specialist nurse and changed once to three times per week (depending on amount of exudate), until full ulcer healing or up to 12 weeks.
Sponsors
Western Vascular Institute, Ireland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Due to the obvious differences between the intervention and comparator, it is impossible to blind the participants or the care providers. However, the investigator, the outcomes assessor and statistician are blinded to treatment received.
Intervention model description
This is a randomised, parallel group, active-control trial, with patients randomised in a 1:1 ratio to one of two treatment arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or more * Provide written informed consent * Venous ulcer present, greater than 10cm2 in surface area * A C6 grading in the CEAP classification
Exclusion criteria
Pregnant (confirmed by β-HCG analysis). Female patients of childbearing potential are advised to adhere to an appropriate form of contraception, and those unwilling to follow contraceptive advice are excluded from the study * Involvement in another clinical trial in the previous six months * Legal incapacity * Patient is bed-ridden or immobile * Ulcer smaller than 10cm2 in surface area * Ischaemic ulcer/s present * Diabetic ulcer/s present * Malignant ulceration/s present * Ulcer exposing bone or tendon * Osteomyelitis * Pseudomonas infection * Presence of gangrene * Deep venous thrombosis (DVT) present * Connective tissue disease present * Presence of any illness that could limit long-term compliance (e.g. epilepsy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to healing | 12 weeks | The time taken for complete closure of the index ulcer or till the wound is judged suitable for skin grafting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of ulcers healed | 12 weeks | The proportion of index ulcers fully healed |
| Ulcer recurrence | 12 months | Wound recurrence rates at six weeks, and three, six and 12 months of follow-up |
Countries
Ireland
Outcome results
None listed