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CTRI Number  CTRI/2009/091/000250 [Registered on: 15/05/2009]
Last Modified On:
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to determine whether local application of autologous bone marrow injections can help in healing chronic wounds 
Scientific Title of Study   A randomised controlled clinical trial to investigate the role of autologous bone marrow derived cells in the healing of chronic wounds 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prakash Jain 
Designation   
Affiliation   
Address  Department of General Surgery Unit 5, Christian Medical College
Vellore
Vellore
TAMIL NADU
632004
India 
Phone  0416-2282085  
Fax    
Email  drprakashjain@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Benjamin Perakath 
Designation   
Affiliation  Professor 
Address  Professor, Department of General Surgery Unit 5
Christian Medical College, Vellore
Vellore
TAMIL NADU
632004
India 
Phone  0416-2282085  
Fax    
Email  sur5@cmcvellore.ac.in  
 
Details of Contact Person
Public Query  
Name  Benjamin Perakath 
Designation   
Affiliation   
Address  Professor, Department of General Surgery Unit 5
Christian Medical College, Vellore
Vellore
TAMIL NADU
632004
India 
Phone  0416-2282085  
Fax    
Email  sur5@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
FLUID research grant, Christian Medical College, Vellore 
 
Primary Sponsor  
Name  Christian Medical College, Vellore, Tamil Nadu, India 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Benjamin Perakath  Department of Surgery Christian Medical College, Vellore Tamil Nadu, India 632004  Department of General Surgery Unit 5, ,Christian Medical College, Vellore-632004
Vellore
TAMIL NADU 		 0416-2282085

sur5@cmcvellore.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board (Ethics Committee) of CMC, Vellore, Tamil Nadu, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Chronic wounds in an adult Indian population,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Local injection of autologous bone marrow derived cells  5 cc processed cells injected 
Comparator Agent  Local injection of autologous peripheral blood  5 cc injected 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  Male or female patients with chronic wounds that had not healed for 3 months or more. Wounds where primary closure could not be achieved. Wounds which were unsuitable for skin grafting.  
 
ExclusionCriteria 
Details  Wounds with active infection defined as copious pus discharge from the wound. Wounds where distal pulses were not palpable Wounds more than 15 cm in any one dimension. Patients with Hansen?s disease. Patients who were pregnant. Patients who were on chemotherapy. Patients who were diagnosed with hematological disease.  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Rate of wound healing as defined by a decrease in wound size over time  Follow up every 2 weeks for 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Standardization of technique of local application of bone marrow cells to chronic wounds  Follow up every 2 weeks for 3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/07/2006 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)   
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is a randomized, single blinded, placebo controlled parallel group trial assessing whether local application of autologous bone marrow derived cells to chronic wounds will augment their healing. The primary outcome is rate of wound healing as measured by decrease in wound size over 3 months. The secondary outcome is standardization of the technique of local application of autologous bone marrow derived cells to chronic wounds. 
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