Negative Pressure Vs. Compression in Venous Ulcers

• ClinicalTrials.gov Identifier: NCT03688841
• Recruitment Status: Completed
• First Posted: September 28, 2018
• Last Update Posted: August 4, 2021
• Sponsor: Western Vascular Institute, Ireland
• Information provided by (Responsible Party): Western Vascular Institute, Ireland

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Varicose Ulcer	Device: Bridged V.A.C.® with compression therapy; Device: Conventional Compression Therapy	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• 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.

• Primary Purpose: Treatment
• Official Title: Bridged Vacuum Assisted Closure (VAC) With Compression vs. Compression Therapy in the Management of Venous Leg Ulcers: A Prospective Randomised Controlled Trial
• Actual Study Start Date: January 19, 2016
• Actual Primary Completion Date: July 1, 2020
• Actual Study Completion Date: December 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Bridged V.A.C.® with compression therapy; A vacuum assisted closure device will be placed on the ulcer. A compression dressing will be placed over the V.A.C.® device	Device: Bridged 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.
Active Comparator: Conventional compression therapy; A Coban™ Lite compression dressings with underlying non-adherent wound contact layer (WCL) dressings will be applied and changed once to three times per week (dependant on exudate).	Device: Conventional 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.

Outcome Measures

Primary Outcome Measures :

1. Time to healing [ Time Frame: 12 weeks ]
   The time taken for complete closure of the index ulcer or till the wound is judged suitable for skin grafting

Secondary Outcome Measures :

1. Proportion of ulcers healed [ Time Frame: 12 weeks ]
   The proportion of index ulcers fully healed
2. Ulcer recurrence [ Time Frame: 12 months ]
   Wound recurrence rates at six weeks, and three, six and 12 months of follow-up

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

Ireland

Department of Vascular Surgery, Western Vascular Institute, Galway University Hospital

Galway, Ireland

Sponsors and Collaborators

Western Vascular Institute, Ireland

Investigators

• Principal Investigator: Sherif Sultan, MD; Western Vascular Institute, Ireland
• Principal Investigator: Wael Tawfick, MD; Western Vascular Institute, Ireland

More Information

• Responsible Party: Western Vascular Institute, Ireland
• ClinicalTrials.gov Identifier: NCT03688841
• Other Study ID Numbers: BVACC-CCD
• First Posted: September 28, 2018
• Last Update Posted: August 4, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: IPD of primary and secondary outcomes, could be made available to other researchers by request, while maintaining participant confidentiality

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Western Vascular Institute, Ireland:

Varicose ulcer; Compression Therapy; Negative Pressure; Vacuum Assisted Closure

Additional relevant MeSH terms:

Varicose Ulcer; Ulcer; Pathologic Processes; Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases