Clinical trial NCT03688841: Negative Pressure Vs. Compression in Venous Ulcers
Official title: Bridged Vacuum Assisted Closure (VAC) With Compression vs. Compression Therapy in the Management of Venous Leg Ulcers: A Prospective Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Ulcer
Keywords: Varicose ulcer
Compression Therapy
Negative Pressure
Vacuum Assisted Closure
Lead sponsor: Western Vascular Institute, Ireland
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Time to healing
timeFrame: 12 weeks
Secondary outcomes:
measure: Proportion of ulcers healed
timeFrame: 12 weeks
measure: Ulcer recurrence
timeFrame: 12 months
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: Department of Vascular Surgery, Western Vascular Institute, Galway University Hospital
Study officials:
affiliation: Western Vascular Institute, Ireland
name: Sherif Sultan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Western Vascular Institute, Ireland
name: Wael Tawfick, MD
role: PRINCIPAL_INVESTIGATOR
References: