Leg UlcerNCT02509533
Comparison of the Use of VAC System in Transplants of Leg Ulcers Versus Usual Dressing Method
A study testing V.A.C.® and dressing in people with Leg Ulcer, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
To evaluate the VAC (Vacuum Assisted Closure) therapy in transplants of leg ulcers versus usual dressing method. The VAC Therapy system consists of: A unit delivering a precise under atmospheric pressure, controlled and regulated in the wound site, Consumables necessary for the implementation of the dressing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leg Ulcer
- What is being tested?
- V.A.C.® and dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Mar 2014
- 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
- patient hospitalized into the dermatology unit
- patient with an evolutive leg ulcer since more than 1 month
- signed informed consent
Who cannot join
- known allergy to one of dressings used in this study
- patient with a non-treated osteomyelitis
- patient with tumoral tissues into the wound
- patient with raw organ or raw blood vessels
- patient with an anticoagulation treatment with a potentially hemorrhagic curative dose
- patient having hemostasis problems that can lead to hemorrhagic exudates
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Use of VAC (Vacuum Assisted Closure) System in Transplants of Leg Ulcers Versus Usual Dressing Method. A Monocentric, Prospective, Randomized, Parallel Groups Study
To evaluate the VAC (Vacuum Assisted Closure) therapy in transplants of leg ulcers versus usual dressing method. The VAC Therapy system consists of:
- A unit delivering a precise under atmospheric pressure, controlled and regulated in the wound site,
- Consumables necessary for the implementation of the dressing,
- Collecting tanks exudates with gel. VAC therapy is a system using negative pressure. It is known to be efficient into care of chronic wounds and ulcerous wounds by increasing the cicatrisation.
This system is systematically used into the dermatology unit of the CHU of Saint-Etienne after transplants of leg ulcers, but no data confirms the interest of this method compared to usual dressing method. This study will provide this data.
- Conditions
- Leg Ulcer
- Being tested
- V.A.C.®, dressing
- Keywords
- Vacuum Assisted Closure
- Medical subject headings
- Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V.A.C.®Device
Patients received V.A.C.® Therapy (KCI medical) after a transplants of leg ulcers.
dressingDevice
Patients received usual dressing method (compresses) after a transplants of leg ulcers
| Study group | Role | What they receive |
|---|---|---|
| V.A.C.® Therapy | Experimental | In this arm, investigators will use the V.A.C.® Therapy after a transplants of leg ulcers. Receives: Device: V.A.C.® |
| usual dressing method (compresses) | Active comparator | In this arm, investigators will use the usual dressing method after a transplants of leg ulcers. Receives: Device: dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of healing between VAC system and compresses for all types of leg ulcers
Number of patients having a wound at least 50% of the grafted area between VAC system and compresses
Measured: 1 month after the transplant
Secondary outcomes (9)
Percentage of healing between VAC system and compresses for all types of leg ulcers
Number of patients having a wound at least 50% of the grafted area between VAC system and compresses
Measured: 3 months after the transplant
Evolution of the pain by Analogic Visual Scale.
Pain score as measured by visual analog scale between VAC system and compresses
Measured: day 0 : just before the transplant
Evolution of the pain by Analogic Visual Scale.
Pain score as measured by visual analog scale between VAC system and compresses
Measured: day 1 : the day after the transplant
Evolution of the pain by Analogic Visual Scale
Pain score as measured by visual analog scale between VAC system and compresses
Measured: Month 1
Quality of life questionnaire score.
Quality of life questionnaire score between VAC system and compresses
Measured: day 0 : just before the transplant
Quality of life questionnaire score.
Quality of life questionnaire score between VAC system and compresses
Measured: Day 5
Quality of life questionnaire score.
Quality of life questionnaire score between VAC system and compresses
Measured: Month 1
Quality of life questionnaire score.
Quality of life questionnaire score between VAC system and compresses
Measured: Month 3
Cost of the treatment.
Cost of the treatment, between VAC system and compresses This coast includes costs of consumables, hospitalisation days and nursing costs
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startSep 2010
- Primary completionOct 2013
- Study completionMar 2014
Why it stopped: difficulties to recruit patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg UlcerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno LABEILLE, MD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509533
- Sponsor's protocol ID
- 1008042
- Other IDs
- 2010-A00371-38
- Status last verified
- Jul 2015
- First submitted
- 21 Jul 2015
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Use of VAC (Vacuum Assisted Closure) System in Transplants of Leg Ulcers Versus Usual Dressing Method. A Monocentric, Prospective, Randomized, Parallel Groups Study
- ClinicalTrials.gov ID
- NCT02509533
- Acronym / sponsor ID
- 1008042
- Conditions
- Leg Ulcer
- Keywords
- Vacuum Assisted Closure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulties to recruit patients.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 28 Jul 2015 (estimated)
- 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.
To evaluate the VAC (Vacuum Assisted Closure) therapy in transplants of leg ulcers versus usual dressing method. The VAC Therapy system consists of:
- A unit delivering a precise under atmospheric pressure, controlled and regulated in the wound site,
- Consumables necessary for the implementation of the dressing,
- Collecting tanks exudates with gel. VAC therapy is a system using negative pressure. It is known to be efficient into care of chronic wounds and ulcerous wounds by increasing the cicatrisation.
This system is systematically used into the dermatology unit of the CHU of Saint-Etienne after transplants of leg ulcers, but no data confirms the interest of this method compared to usual dressing method. This study will provide this data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V.A.C.® Therapy | Experimental | Device: V.A.C.®In this arm, investigators will use the V.A.C.® Therapy after a transplants of leg ulcers. |
| usual dressing method (compresses) | Active comparator | Device: dressingIn this arm, investigators will use the usual dressing method after a transplants of leg ulcers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient hospitalized into the dermatology unit
- patient with an evolutive leg ulcer since more than 1 month
- signed informed consent
Key exclusion criteria (6 listed)
- known allergy to one of dressings used in this study
- patient with a non-treated osteomyelitis
- patient with tumoral tissues into the wound
- patient with raw organ or raw blood vessels
- patient with an anticoagulation treatment with a potentially hemorrhagic curative dose
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 |
|---|---|---|
| V.A.C.®Patients received V.A.C.® Therapy (KCI medical) after a transplants of leg ulcers. | Device | V.A.C.® Therapy |
| dressingPatients received usual dressing method (compresses) after a transplants of leg ulcers | Device | usual dressing method (compresses) |
Primary outcome
Percentage of healing between VAC system and compresses for all types of leg ulcers
Time frame: 1 month after the transplant
Number of patients having a wound at least 50% of the grafted area between VAC system and compresses
9 secondary outcomes
Percentage of healing between VAC system and compresses for all types of leg ulcers
Time frame: 3 months after the transplant
Evolution of the pain by Analogic Visual Scale.
Time frame: day 0 : just before the transplant
Evolution of the pain by Analogic Visual Scale.
Time frame: day 1 : the day after the transplant
Evolution of the pain by Analogic Visual Scale
Time frame: Month 1
Quality of life questionnaire score.
Time frame: day 0 : just before the transplant
Quality of life questionnaire score.
Time frame: Day 5
Quality of life questionnaire score.
Time frame: Month 1
Quality of life questionnaire score.
Time frame: Month 3
Cost of the treatment.
Time frame: Month 3
Results and safety
The study was stopped early (reason given: difficulties to recruit patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
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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.
Bruno LABEILLE, MD principal investigator
CHU de SAINT-ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing V.A.C.® and dressing in people with Leg Ulcer, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 28 Jul 2015. 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 France. 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 was stopped early (reason given: difficulties to recruit patients.). Results are not available in the source record.
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?
Percentage of healing between VAC system and compresses for all types of leg ulcers (time frame: 1 month after the transplant). 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 28 Jul 2015.