FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/073506 [Registered on: 06/09/2024] Trial Registered Prospectively
Last Modified On: 03/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   New Dimensions in Analysis of various Reconstruction Options for Complex Ankle Defects 
Scientific Title of Study   A comparative analysis of the outcome of various reconstruction options in complex ankle defects. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjana S I 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences , Jodhpur 
Address  Department of Burns & Plastic Surgery, AIIMS Jodhpur, Basni, Jodhpur.

Jodhpur
RAJASTHAN
342005
India 
Phone  9972671479  
Fax    
Email  sanjanasi711@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prakash Chandra Kala 
Designation  Additonal Professor 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Burns & Plastic Surgery, AIIMS Jodhpur, Basni, Jodhpur.

Jodhpur
RAJASTHAN
342005
India 
Phone  8460952204  
Fax    
Email  drpckala@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prakash Chandra Kala 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Burns & Plastic Surgery, AIIMS Jodhpur, Basni, Jodhpur.

Jodhpur
RAJASTHAN
342005
India 
Phone  8460952204  
Fax    
Email  drpckala@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Jodhpur, Basni, Jodhpur,Rajasthan 342005 
 
Primary Sponsor  
Name  Dr Sanjana S I 
Address  Department of Burns and Plastic Surgery, AIIMS Jodhpur, Basni, Jodhpur  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjana S I  All India Institute of Medical sciences, Jodhpur  Department of Burns And Plastic surgery Room No- 403, 4th floor, A block, OPD building, All India Institute of Medical Sciences Jodhpur, Basni
Jodhpur
RAJASTHAN 		 9972671479

sanjanasi711@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of Medical Sciences, Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S910||Open wound of ankle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Free flap  17 Ankle defect cases will be reconstructed using free flap in a duration of 1 year 
Comparator Agent  Locoregional flap  17 ankle defect cases will be reconstructed using locoregional flap in a duration of 1 year 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients with complex ankle defects with paucity of local soft tissue 
 
ExclusionCriteria 
Details  1 Patients who previously underwent locoregional/free flap for same or any other indication, which precludes both free and locoregional flap.
2 Patients with loss of sensation of foot
3 Pediatric age group (5 years and below). 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the outcomes of various reconstructive options for complex ankle defects.
 		 to assess the outcomes at immediate, at 2 weeks, 1 month, 3-month intervals postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
to study the aesthetic outcome of various reconstructive options for complex ankle defect  to assess the outcomes at 3-month interval postoperatively 
To assess the functional outcome of various reconstructive option   will be assessed after the patient is ambulatory/ bony union 
To assess the psychosocial outcomes of various reconstructive options for complex ankle defects   assessed after the completion of ambulation/ 3 months whichever is earliest 
To assess the impact of various pre operative factors & complications on long term outcomes  assessed on 3 month, 6 month /last follow up in postoperative period 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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   N/A 
Date of First Enrollment (India)   14/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sanjanasi711@gmail.com].

  6. For how long will this data be available start date provided 11-03-2026 and end date provided 11-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Lower extremity damage management is one of the disciplines of reconstructive surgery that has emerged significantly over time.  Foot and ankle are responsible for ambulation and for the posture of human body. There is a lack of local soft tissue, blood supply and the long bones are subcutaneous which makes them exposed, even in small sized defects. This poses challenging problems for surgeons in cases of lower extremity trauma.

It is a Randomized controlled trial comparing the outcomes of  free flap and locoregional flap reconstruction in complex ankle defects. It also includes studying the  impact of various pre-operative factors and complications on long term outcomes.

It includes  patients with complex ankle defects with paucity of local soft tissue. The primary aim is to compare  the aesthetic, functional and psychosocial outcomes of  free flap and locoregional flap reconstruction in complex ankle defects. It also includes studying the impact of various pre-operative factors and complications on long term outcomes. All patients will be asked to sign written informed consent forms. Patients will be divided into two groups A and B by the SNOSE method of randomization. Group A patients will undergo free flap reconstruction and group B will undergo locoregional reconstruction. Concealment and blinding is not applicable.

 
Close