Venous UlcerTAPIRSNCT02798445
TAPIRS Technique Plus Adjustable Compression System in Treatment of Venous Leg Ulcers
A study testing TAPIRS in people with Venous Ulcer, run by Hospital Occidente de Kennedy.
Trial summary
The aim of this study is to determine the percentage of healing of active venous ulcers following Terminal Axial Perforator Interruption Reflux Source (tapirs technique) and adjustable compression system versus a control group using the traditional multilayer bandages. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Ulcer
- What is being tested?
- TAPIRS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2017
- 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
- Venous Ulcer Ulcer present for at least 4 weeks Ankle-arm index greater or equal to 0.8 mmHg
Who cannot join
- Severe hepatic disease Severe cardiac disease Severe pulmonary disease Deep venous thrombosis Active participation in other clinical trials limitation in the ankle movements others limitations to move their self
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Trial : Terminal Axial Perforator Interruption Reflux Source (TAPIRS ) Plus Adjustable Compression System in Treatment of Venous Leg Ulcers Versus Multilayer Bandage Treatment
The aim of this study is to determine the percentage of healing of active venous ulcers following Terminal Axial Perforator Interruption Reflux Source (tapirs technique) and adjustable compression system versus a control group using the traditional multilayer bandages.
Read the detailed description
Venous ulcer due to venous insufficiency causes an important morbidity to those people suffering from this condition. Most of therapies available under the obligatory health plan (POS, acronym in Spanish) to date cover the cleaning of the ulcerous lesion and its medical handling using saline solutions, topical antibiotics and elastic dressings, implying an important intake from health resources due to its chronicity and the delay in ulcers healing, which usually takes periods ranging from 12 months to several years. Therapeutic alternatives, which can guarantee optimal, fast and persistent in time healing, should be identified.
The aim of this study is to determine the percentage of healing of active venous ulcers (using a clinical, etiological, anatomic and physiopathologic classification (CEAP), C6) following Endovascular Laser Treatment (EVLT) of axial vein hypertension plus ultrasound-guided foam sclerotherapy of superficial venous reflux under knee, closing perforator veins and terminal reflux under de ulcer in patients with chronic venous ulceration (TAPIRS technique) plus compression with an adjustable compression system (juxta cures) versus a control group using the traditional multilayer bandages. The investigators expect that the minimal surgical invasive approach closing all the superficial venous reflux plus adjustable compression system will diminish the time of ulcer healing compared with standard treatment of multilayer bandage care.
- Conditions
- Venous Ulcer
- Being tested
- TAPIRS, CONTROL
- Keywords
- venous ulcer, vein, juxta cures, foam, laser
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAPIRSOther
Terminal Axial Perforator Interruption Reflux Source plus Adjustable compression system
CONTROLOther
Multilayer bandages and wound care
| Study group | Role | What they receive |
|---|---|---|
| tapirs | Experimental | this group will have surgery with endovascular laser treatment (EVLT) in the axial vein and foam sclerotherapy echo-guided in perforator veins and veins in relation with the ulcer, after the surgery the patients will have conventional wound care plus juxta cure system that give a continuous compression in the leg. Receives: Other: TAPIRS |
| multilayer bandage | Active comparator | multilayer bandage and conventional wound care (grade 1A) recommendation in management of vein ulcers. gold standard Receives: Other: CONTROL |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing rates
determine healing rates between two groups
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Venous 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
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Occidente de Kennedy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ernesto nieves, Hospital Occidente de Kennedy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798445
- Sponsor's protocol ID
- TAPIRS
- Acronym
- TAPIRS
- Status last verified
- Aug 2016
- First submitted
- 5 May 2016
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Darvall KA, Sam RC, Bate GR, Adam DJ, Silverman SH, Bradbury AW. Photoplethysmographic venous refilling times following ultrasound guided foam sclerotherapy for symptomatic superficial venous reflux: relationship with clinical outcomes. Eur J Vasc Endovasc Surg. 2010 Aug;40(2):267-72. doi: 10.1016/j.ejvs.2010.02.025. Epub 2010 Apr 1.
PubMed 20362477Pang KH, Bate GR, Darvall KA, Adam DJ, Bradbury AW. Healing and recurrence rates following ultrasound-guided foam sclerotherapy of superficial venous reflux in patients with chronic venous ulceration. Eur J Vasc Endovasc Surg. 2010 Dec;40(6):790-5. doi: 10.1016/j.ejvs.2010.08.011. Epub 2010 Sep 27.
PubMed 20875753
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial : Terminal Axial Perforator Interruption Reflux Source (TAPIRS ) Plus Adjustable Compression System in Treatment of Venous Leg Ulcers Versus Multilayer Bandage Treatment
- ClinicalTrials.gov ID
- NCT02798445
- Acronym / sponsor ID
- TAPIRS / TAPIRS
- Conditions
- Venous Ulcer
- Keywords
- venous ulcer, vein, juxta cures, foam, laser
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Hospital Occidente de KennedyUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 14 Jun 2016 (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.
The aim of this study is to determine the percentage of healing of active venous ulcers following Terminal Axial Perforator Interruption Reflux Source (tapirs technique) and adjustable compression system versus a control group using the traditional multilayer bandages.
Detailed description
Venous ulcer due to venous insufficiency causes an important morbidity to those people suffering from this condition. Most of therapies available under the obligatory health plan (POS, acronym in Spanish) to date cover the cleaning of the ulcerous lesion and its medical handling using saline solutions, topical antibiotics and elastic dressings, implying an important intake from health resources due to its chronicity and the delay in ulcers healing, which usually takes periods ranging from 12 months to several years. Therapeutic alternatives, which can guarantee optimal, fast and persistent in time healing, should be identified.
The aim of this study is to determine the percentage of healing of active venous ulcers (using a clinical, etiological, anatomic and physiopathologic classification (CEAP), C6) following Endovascular Laser Treatment (EVLT) of axial vein hypertension plus ultrasound-guided foam sclerotherapy of superficial venous reflux under knee, closing perforator veins and terminal reflux under de ulcer in patients with chronic venous ulceration (TAPIRS technique) plus compression with an adjustable compression system (juxta cures) versus a control group using the traditional multilayer bandages. The investigators expect that the minimal surgical invasive approach closing all the superficial venous reflux plus adjustable compression system will diminish the time of ulcer healing compared with standard treatment of multilayer bandage care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tapirs | Experimental | Other: TAPIRSthis group will have surgery with endovascular laser treatment (EVLT) in the axial vein and foam sclerotherapy echo-guided in perforator veins and veins in relation with the ulcer, after the surgery the patients will have conventional wound care plus juxta cure system that give a continuous compression in the leg. |
| multilayer bandage | Active comparator | Other: CONTROLmultilayer bandage and conventional wound care (grade 1A) recommendation in management of vein ulcers. gold standard |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Venous Ulcer Ulcer present for at least 4 weeks Ankle-arm index greater or equal to 0.8 mmHg
Key exclusion criteria (1 listed)
- Severe hepatic disease Severe cardiac disease Severe pulmonary disease Deep venous thrombosis Active participation in other clinical trials limitation in the ankle movements others limitations to move their self
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 |
|---|---|---|
| TAPIRSTerminal Axial Perforator Interruption Reflux Source plus Adjustable compression system | Other | tapirs |
| CONTROLMultilayer bandages and wound care | Other | multilayer bandage |
Primary outcome
healing rates
Time frame: 12 weeks
determine healing rates between two groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
- Background: PubMed 20362477Darvall KA, Sam RC, Bate GR, Adam DJ, Silverman SH, Bradbury AW. Photoplethysmographic venous refilling times following ultrasound guided foam sclerotherapy for symptomatic superficial venous reflux: relationship with clinical outcomes. Eur J Vasc Endovasc Surg. 2010 Aug;40(2):267-72. doi: 10.1016/j.ejvs.2010.02.025. Epub 2010 Apr 1.
- Background: PubMed 20875753Pang KH, Bate GR, Darvall KA, Adam DJ, Bradbury AW. Healing and recurrence rates following ultrasound-guided foam sclerotherapy of superficial venous reflux in patients with chronic venous ulceration. Eur J Vasc Endovasc Surg. 2010 Dec;40(6):790-5. doi: 10.1016/j.ejvs.2010.08.011. Epub 2010 Sep 27.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing TAPIRS in people with Venous Ulcer, run by Hospital Occidente de Kennedy.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ernesto nieves, md (573108800230, ernestonieves1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healing rates (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02798445, which also lists 2 linked publications.
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 23 Aug 2016; AzTrials last refreshed its copy on 6 Nov 2026.