TAPIRS Technique Plus Adjustable Compression System in Treatment of Venous Leg Ulcers
TAPIRS
Clinical Trial : Terminal Axial Perforator Interruption Reflux Source (TAPIRS ) Plus Adjustable Compression System in Treatment of Venous Leg Ulcers Versus Multilayer Bandage Treatment
1 other identifier
interventional
26
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedFirst Posted
Study publicly available on registry
June 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedAugust 23, 2016
August 1, 2016
6 months
May 5, 2016
August 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
healing rates
determine healing rates between two groups
12 weeks
Study Arms (2)
tapirs
EXPERIMENTALthis 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 COMPARATORmultilayer bandage and conventional wound care (grade 1A) recommendation in management of vein ulcers. gold standard
Interventions
Eligibility Criteria
You may qualify if:
- Venous Ulcer Ulcer present for at least 4 weeks Ankle-arm index greater or equal to 0.8 mmHg
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 20362477BACKGROUNDPang 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.
PMID: 20875753BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- vascular surgeon, md.
Study Record Dates
First Submitted
May 5, 2016
First Posted
June 14, 2016
Study Start
June 1, 2016
Primary Completion
December 1, 2016
Study Completion
June 1, 2017
Last Updated
August 23, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share