Varicose UlcerNCT03688841
Negative Pressure Vs. Compression in Venous Ulcers
A study testing Bridged V.A.C.® with compression therapy and Conventional Compression Therapy in people with Varicose Ulcer, run by Western Vascular Institute, Ireland at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Ulcer
- What is being tested?
- Bridged V.A.C.® with compression therapy and Conventional Compression Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIreland
- Study dates
- 19 Jan 2016to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Department of Vascular Surgery, Western Vascular Institute, Galway University Hospital
Galway
About this study
Official title: Bridged Vacuum Assisted Closure (VAC) With Compression vs. Compression Therapy in the Management of Venous Leg Ulcers: A Prospective Randomised Controlled Trial
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.
Read the 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.
- Conditions
- Varicose Ulcer
- Being tested
- Bridged V.A.C.® with compression therapy, Conventional Compression Therapy
- Keywords
- Varicose ulcer, Compression Therapy, Negative Pressure, Vacuum Assisted Closure
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bridged V.A.C.® with compression therapyDevice
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 TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Bridged V.A.C.® with compression therapy | Experimental | A vacuum assisted closure device will be placed on the ulcer. A compression dressing will be placed over the V.A.C.® device Receives: Device: Bridged V.A.C.® with compression therapy |
| Conventional compression therapy | Active comparator | 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). Receives: Device: Conventional Compression Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to healing
The time taken for complete closure of the index ulcer or till the wound is judged suitable for skin grafting
Measured: 12 weeks
Secondary outcomes (2)
Proportion of ulcers healed
The proportion of index ulcers fully healed
Measured: 12 weeks
Ulcer recurrence
Wound recurrence rates at six weeks, and three, six and 12 months of follow-up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start19 Jan 2016
- Primary completion1 Jul 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Vascular Institute, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sherif Sultan, MD, Principal investigator, Western Vascular Institute, IrelandWael Tawfick, MD, Principal investigator, Western Vascular Institute, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688841
- Sponsor's protocol ID
- BVACC-CCD
- Status last verified
- Aug 2021
- First submitted
- 26 Sep 2018
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD of primary and secondary outcomes, could be made available to other researchers by request, while maintaining participant confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridged Vacuum Assisted Closure (VAC) With Compression vs. Compression Therapy in the Management of Venous Leg Ulcers: A Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03688841
- Acronym / sponsor ID
- BVACC-CCD
- Conditions
- Varicose Ulcer
- Keywords
- Varicose ulcer, Compression Therapy, Negative Pressure, Vacuum Assisted Closure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Western Vascular Institute, IrelandUniversity, hospital or other
- Study start
- 19 Jan 2016 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bridged V.A.C.® with compression therapy | Experimental | Device: Bridged V.A.C.® with compression therapyA vacuum assisted closure device will be placed on the ulcer. A compression dressing will be placed over the V.A.C.® device |
| Conventional compression therapy | Active comparator | Device: Conventional Compression TherapyA 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bridged V.A.C.® with compression therapyPatients 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. | Device | Bridged V.A.C.® with compression therapy |
| Conventional Compression TherapyPatients 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. | Device | Conventional compression therapy |
Primary outcome
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
2 secondary outcomes
Proportion of ulcers healed
Time frame: 12 weeks
Ulcer recurrence
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Individual participant dataSharing planned: No. IPD of primary and secondary outcomes, could be made available to other researchers by request, while maintaining participant confidentiality
Related trials for Varicose Ulcer
Active, not recruitingPhase 4
A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TL
Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU)
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
RecruitingPhase 4
Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Leg Ulcer
Recruiting
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
Venous Ulcer of Leg
Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherif Sultan, MD principal investigator
Western Vascular Institute, Ireland
Wael Tawfick, MD principal investigator
Western Vascular Institute, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bridged V.A.C.® with compression therapy and Conventional Compression Therapy in people with Varicose Ulcer, run by Western Vascular Institute, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to healing (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.