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Completed

NCT Number: NCT03688841

Negative Pressure Vs. Compression in Venous Ulcers

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.

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Key information

Conditions

Varicose Ulcer Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Veins Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Galway, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bridged V.A.C.® with compression therapy

Device

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.

Conventional Compression Therapy

Device

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Western Vascular Institute, Ireland

Other

Registry information

Official study title

Bridged Vacuum Assisted Closure (VAC) With Compression vs. Compression Therapy in the Management of Venous Leg Ulcers: A Prospective Randomised Controlled Trial

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 28, 2018
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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