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CTRI Number  CTRI/2025/05/087166 [Registered on: 20/05/2025] Trial Registered Prospectively
Last Modified On: 20/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Reconstruction of dorsal foot defects: Comparing Skin Substitutes with Natural Tissue Flaps 
Scientific Title of Study   Comparative analysis between dermal substitutes and free fasciocutaneous flaps in reconstruction of dorsal foot defects - A Randomized Controlled Trail. 
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 Deepti Katrolia  
Designation  Associate Professor  
Affiliation  AIIMS JODHPUR 
Address  Department of Burns and Plastic surgery ,All India Institute of Medical Sciences , Basni,jodhpur , Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  8587997469  
Fax    
Email  deepti.katrolia@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepti Katrolia  
Designation  Associate Professor  
Affiliation  AIIMS JODHPUR 
Address  Department of Burns and Plastic surgery ,All India Institute of Medical Sciences , Basni,jodhpur , Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  8587997469  
Fax    
Email  deepti.katrolia@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Praveen Kumar N 
Designation  Senior Resident 
Affiliation  AIIMS JODHPUR 
Address  Department of Burns and Plastic surgery ,All India Institute of Medical Sciences , Basni,jodhpur , Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  8792698650  
Fax    
Email  praveenkumar19934@gmail.com  
 
Source of Monetary or Material Support  
All india institute of medical sciences jodhpur  
 
Primary Sponsor  
Name  All india institute of medical sciences jodhpur 
Address  Department of Burns and Plastic surgery ,All India Institute of Medical Sciences , Basni,jodhpur , Rajasthan 342005 
Type of Sponsor  Government medical college 
 
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 Praveen Kumar N  All India Institute of Medical Sciences   Department of Burns and Plastic surgery ,All India Institute of Medical Sciences , Basni,jodhpur , Rajasthan 342005
Jodhpur
RAJASTHAN 
8792698650

praveenkumar19934@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All india institute of medical sciences , jodhpur Institutional Ethics Committee( Clinical Trial)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dermal substitutes   selected patients will undergo Dermal Substitute application over raw area of dorsum of foot along with negative pressure wound therapy and after post operative 21 days , patient will undergo delamination of superficial layer of dermal substitute with Split thickness skin grafting over raw area and patient will be assesed in immediate post operative period at 3 months and 6 months post operatively for aesthetic and functional outcomes  
Comparator Agent  Free fasciocutaneous flaps   selected paitents will undergo free fasciocutaneous flap surgery for raw area over dorsum of foot and patient will be assessed in immediate post operative period at 3 months and 6 months post operatively for aesthetic and functional outcomes. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All patients undergoing dermal substitute application and free fasciocutaneous flaps for reconstruction of dorsal foot defects due to trauma ,infections post oncologic resection , diabetes and ulcers size more and 3cmsq and below 25cmsq 
 
ExclusionCriteria 
Details  Patients with peripheral vascular disease for limb defects , unfit for prolonged surgeries and patients with psychiatric disorders  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess functional recovery and aesthetic outcome in immediate and late post- operative groups operative period in both the groups   Immediate , At 3 weeks and monthly for 6 months  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate healing time, sensation recovery, complication rates,duration of hospital stay and cost effectiveness in both the groups   Immediate , At 3 weeks and monthly for 6 months 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   16/06/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary   A prospective randomized controlled trial will be conducted to compare the functional, aesthetic, and psychosocial outcomes of dermal substitutes versus free fasciocutaneous flaps in the reconstruction of dorsal foot defects. Patients will be randomly allocated into two groups using a computer-generated randomization sequence. Outcome measures will be assessed in the immediate postoperative period, at 3 weeks, and at monthly intervals for a total duration of 6 months. 
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