FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/076815 [Registered on: 14/11/2024] Trial Registered Prospectively
Last Modified On: 22/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   3D printed skin for diabetic wound healing 
Scientific Title of Study   USE OF 3D PRINTED SKIN AS SKIN GRAFT IN CHRONIC NON-HEALING ULCERS 
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 Vaishali Gaikwad 
Designation  Medical Superintendent, Professor 
Affiliation  Dr. D. Y. Patil Medical College, Hospital and Research Centre, Kadamwadi, Kolhapur 
Address  Department of Surgery,OPD, Room no.5,Dr. D. Y. Patil Medical College, Hospital and Research Cenre, Kadamwadi, Kolhapur
Department of Surgery,OPD, Room no.5,Dr. D. Y. Patil Medical College, Hospital and Research Cenre, Kadamwadi, Kolhapur
Kolhapur
MAHARASHTRA
416005
India 
Phone  9822379069  
Fax    
Email  drvaishaligaikwad@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vaishali Gaikwad 
Designation  Medical Superintendent, Professor 
Affiliation  Dr. D. Y. Patil Medical College, Hospital and Research Centre, Kadamwadi, Kolhapur 
Address  Department of Surgery,OPD, Room no.5,Dr. D. Y. Patil Medical College, Hospital and Research Cenre, Kadamwadi, Kolhapur
Department of Surgery,OPD, Room no.5,Dr. D. Y. Patil Medical College, Hospital and Research Cenre, Kadamwadi, Kolhapur
Kolhapur
MAHARASHTRA
416005
India 
Phone  9822379069  
Fax    
Email  drvaishaligaikwad@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manchikalapudi Sujitha 
Designation  DOCTOR 
Affiliation  Dr. D. Y. Patil Medical College, Hospital and Research Centre, Kadamwadi, Kolhapur 
Address  Department of Surgery,OPD, Room no.5,Dr. D. Y. Patil Medical College, Hospital and Research Cenre, Kadamwadi, Kolhapur
Department of Surgery,OPD, Room no.5,Dr. D. Y. Patil Medical College, Hospital and Research Cenre, Kadamwadi, Kolhapur
Kolhapur
MAHARASHTRA
416005
India 
Phone  6300395455  
Fax    
Email  sujithachowdary1996@gmail.com  
 
Source of Monetary or Material Support  
Dr. D.Y.Patil Education Society, Kadamwadi, Kolhapur, 416006, Maharashtra, India 
 
Primary Sponsor  
Name  Dr Vaishali Gaikwad 
Address  Dr. D. Y. Patil Medical College, Hospital and Research Centre, Kadamwadi, Kolhapur 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Meghnad Ganesh Joshi  Central Research Laboraory, 4th floor,Dr. D. Y. Patil Medical College, Hospital and Research Centre, Kadamwadi, Kolhapur 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr SUJITHA MANCHIKALAPUDI  Dr. D.Y.Patil Medical College, Hospital and Research Institute  Department of surgery, Kadamwadi, Kolhapur, Maharashtra
Kolhapur
MAHARASHTRA 		 8374414051

sujithachowdary1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, D.Y.Pati. Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  3D printed skin  It is made up of xenogenic skin, polymerized with PVA to form a bioink. It has extracellular matrix which attracts cells and accelerate wound healing. The skin graft will be applied to the wounded area. The graft will have extracellular material which helps to heal the wound faster by attracting platelets to the site of injury 
Comparator Agent  Autologous skin graft  Isografting is a standard procedure where the part of donar skin is applied to the wounded area. The autologous skin graft will be applied by following the standard protocol. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  The 3D-printed skin grafts are made up of xenogenic skin composed of extracellular matrix. This graft will be sterilized and used on the wounded area as a treatment.  
 
ExclusionCriteria 
Details  All the patients who do not follow up in OPD. Patients with diabetic foot ulcers undergoing amputation. Patients with immunocompromised status. Patients with osteomyelitis or gangrenous ulcers. All the patients who do not give consent for the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of the study will be :
1. Acceptance of the skin graft
2. Wound healing rate
3. Incidence of wound closure 		 4 to 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Safety & Tolerability
Quality of Wound Healing
Assessment of scar
Pain Reduction
Patient Satisfaction & Quality of Life
Cost-effectiveness 		 7-8 weeks 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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)   25/11/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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 - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The 3D printed skin grafts are made up of xenogenic skin polymerized with biological polymers lika Poly- Vinyl Alcohol. These grafts contains skin specific extracellular matrix which helps the healing of the wound if applied to site of injury. The extracellular matrix will accelerate the healing by attracting the cells and facilitating the binding of platelets to the injured site. As the diabetic wounds are most complicated wounds and have problems of healing due to different reasons; we are targeting these wounds to check the efficacy of the 3D printed skin graft. Hence this study is designed for evaluation of the efficacy of formulated artificial skin for diabetic wound uclers.   
Close