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CTRI Number  CTRI/2010/091/000230 [Registered on: 12/03/2010]
Last Modified On: 08/03/2013
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Randomized Trial of the Flexitouch Compression System as an Adjunctive Treatment for Venous Stasis Ulcer 
Scientific Title of Study   Phase IV A Randomized Trial of the Flexitouch Compression System as an Adjunctive Treatment for Venous Stasis Ulcer 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NCT00534937   ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr N Sekar 
Designation   
Affiliation   
Address  Apollo HOspital
Greams Lane
Chennai
TAMIL NADU
600 006
India 
Phone  044- 28293333 / 28290200  
Fax    
Email  dr_nsekar@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Hrishikesh 
Designation   
Affiliation   
Address  iProcess India

Bangalore
KARNATAKA
560025
India 
Phone  080-4111 7197  
Fax    
Email  hrishi@iprocess.net  
 
Details of Contact Person
Public Query  
Name  Dr Hrishikesh 
Designation   
Affiliation   
Address  iProcess India

Bangalore
KARNATAKA
560025
India 
Phone  080-4111 7197  
Fax    
Email  hrishi@iprocess.net  
 
Source of Monetary or Material Support  
Tactile Systems Technology 1331 Tyler Street NE, Suite 200 Minneapolis, MN 55413 
 
Primary Sponsor  
Name  Tactile Systems Technology 1331 Tyler Street NE, Suite 200 Minneapolis, MN 55413 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr N Sekar  Apollo Hospital   Apollo Hospital,Greams Lane-600 006
Chennai
TAMIL NADU 		 044- 28293333 / 28290200

dr_nsker@yahoo.co.in 
Dr Suresh  Jain Institute of Vascular Sciences  Millers Road,Vasanthanagar-560052
Bangalore
KARNATAKA 		 080-22207188

research_jainvascular@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Venous Stasis Ulcer,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Compression wrapping  Short-stretch compression wrap will be applied  
Intervention  Flexitouch compression pump  In addition to short-stretch wrapping, this group will received once-daily Flexitouch compression pump, both at home and during the once-a-week clinic visits.  
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  This study will enroll patients in a prospective manner with chronic venous insufficiency and venous stasis ulceration as determined from clinical presentation, positive venous reflux testing, or both. Patients must be 18 years old or more. The VSU size must be in the range 1-64 cm2. The ulcer must extend through both the epidermis and dermis, with no exposed tendon or bone. The VSU must have been present for more than 1 month. The ulcer must be located between and including the knee and ankle. The wound bed must have viable tissues with granulation tissue.  
 
ExclusionCriteria 
Details  This study will enroll patients in a prospective manner with chronic venous insufficiency and venous stasis ulceration as determined from clinical presentation, positive venous reflux testing, or both. Patients must be 18 years old or more. The VSU size must be in the range 1-64 cm2. The ulcer must extend through both the epidermis and dermis, with no exposed tendon or bone. The VSU must have been present for more than 1 month. The ulcer must be located between and including the knee and ankle. The wound bed must have viable tissues with granulation tissue.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary study objective is to determine whether the complete healing rate of venous stasis ulcers at 12 weeks is improved by the addition of Flexitouch® System compression therapy to a standard regimen of compression wrapping.   12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Time to healing of the venous stasis ulcer Percentage reduction in volume of the affected limb Reduction in wound surface area  12 weeks 
 
Target Sample Size
Modification(s)  		 Total Sample Size="126"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  01/09/2007 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   The study is multicenter randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study. The study is planned to be conducted in 4 centers in US and 2 centers in India. The planned enrollment is 126 and for India the target is 80. The primary objective of the study is to determine whether the complete healing rate of venous stasis ulcers at 12 weeks is improved by the addition of Flexitouch® System compression therapy to a standard regimen of compression wrapping. The treatment duration is for 80 days. Enrollment has been commenced in the US and 43 patients are randomized. The enrollment in India will start from 10th april 2010. 
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