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CTRI Number  CTRI/2025/02/080589 [Registered on: 14/02/2025] Trial Registered Prospectively
Last Modified On: 12/02/2025
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   Healing of chronic non-healing wounds with Nanofat grafting. 
Scientific Title of Study   Impact of Nanofat grafting on healing outcomes in chronic non-healing wounds: A randomized, controlled study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
REF/2025/01/098337  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vinitha Nair 
Designation  SR1 in plastic and reconstructive surgery  
Affiliation  Padmashree Dr. DY Patil School of medicine 
Address  Room no. 127 Department: plastic and reconstructive surgery Ayyappa temple road,Dr Dy patil Vidyanagar, sector 5, Nerul,navi mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9823457277  
Fax    
Email  vinita.0806@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Manpreet Kaur Juneja 
Designation  AP in plastic and reconstructive surgery  
Affiliation  Padmashree Dr. DY Patil School of medicine 
Address  Room no. 127 Department: Plastic and reconstructive surgery Ayyappa temple road, Dr Dy patil Vidyanagar, sector 5, Nerul, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9823457277  
Fax    
Email  manpreet.juneja@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Dr Vinitha Nair 
Designation  SR1 in plastic and reconstructive surgery  
Affiliation  Padmashree Dr. DY Patil School of medicine 
Address  Room no. 127 Department: Plastic and reconstructive surgery Ayyappa temple road, Dr Dy patil Vidyanagar, sector 5, Nerul, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9823457277  
Fax    
Email  vinita.0806@yahoo.co.in  
 
Source of Monetary or Material Support  
Room no. 127 Department: Plastic and reconstructive surgery Ayyappa temple road, Dr Dy patil Vidyanagar, sector 5, Nerul, Navi Mumbai  
 
Primary Sponsor  
Name  DY Patil Hospital 
Address  Ayyappa Temple road, DR D Y Patil Vidyanagar, Sector 5, Nerul, Navi mumbai, Maharashtra-400706 
Type of Sponsor  Private 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 Vinitha Nair  Dr. D Y Patil Hospital  Room no. 127 Department: Plastic and reconstructive surgery Ayyappa temple road, Dr Dy patil Vidyanagar, sector 5, Nerul, Navi Mumbai
Thane
MAHARASHTRA 		 9823457277

vinita.0806@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Biomedical and Health Research  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  nanofat grafting in people with chronic or acute wounds  The patients fat tissue is first removed from a donor site, such as the back, abdomen, or hips, in order to create nanofat. A typical liposuction tool is used to perform negative pressure liposuction. The liposuction tube was chosen to have a sharp 1-mm-diameter side hole and a 3-mm-diameter cannula with several orifices. The fat that is collected is filtered through a sterile nylon cloth with a 0.5-mm pore size and rinsed with regular saline. Two 10-mm syringes are filled with the filtered fat and fitted with Luer-Lok connecting tubes. About thirty push-and-pulls later, the granular fat is observed to turn chylous. Ultimately, a second filtering of the emulsified fat is performed using 0.6 mm-diameter nylon gauze. The gathered nanofat is injected intradermally with a 27-G needle Frequency : Nano fat will be acquired and injected into the patients 1 time. Duration : check dressing will be done on Post Operative Day 3. Followed by 6th day and 9th then in 2nd week, 3rd week and 4th week. 
Comparator Agent  Standard treatment  Standard wound care without injecting nanofat graft Frequency and duration: Every alternate day dressing for 4 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  subject with acute/chronic wound or ulcers
wounds with adequate arterial blood supply in the target limb
adequately debrided wound without any slough 
 
ExclusionCriteria 
Details  severe debility
Patients on ventilator support
Are pregnant or lactating
Have a known allergy or are sensitive to any dressing material
Have a known or suspected disease of the immune system
Have has had surgery in past 30days to increase blood flow into your leg or foot
Patients who refused to give consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Faster healing of chronic and acute wounds and ulcer in nanofat graft vs standard care
2. Reduce size of wound in nanofat graft vs standard care  		 check dressing will be done on Post Operative Day 3. Followed by 6th day and 9th then in 2nd week, 3rd week and 4th week. 
 
Secondary Outcome  
Outcome  TimePoints 
Safety in nanofat graft vs standard care  2 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   25/02/2025 
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="11"
Days="2" 
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  
Chronic non-healing wounds pose significant challenges in clinical care, leading to prolonged morbidity and substantial healthcare costs. Emerging therapies, such as nanofat grafting, have shown promise due to their regenerative potential. Nanofat is derived from adipose tissue and contains a high concentration of stromal vascular fraction (SVF) cells, including mesenchymal stem cells, which possess anti-inflammatory, angiogenic, and wound-healing properties.

This randomized controlled trial aims to evaluate the efficacy of nanofat grafting in improving healing outcomes for chronic non-healing wounds compared to standard wound care. The study includes patients with chronic wounds, such as diabetic foot ulcers and venous leg ulcers, who are randomized into two groups: one receiving nanofat grafting and the other receiving standard care alone. Key outcomes include wound closure rate, time to complete healing, reduction in wound size, pain scores, and improvement in quality of life.

Preliminary data suggests that nanofat grafting can accelerate wound healing by enhancing angiogenesis, reducing inflammation, and promoting tissue regeneration. This trial aims to provide robust evidence to support the integration of nanofat grafting into clinical practice for chronic wound management.

 
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