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CTRI Number  CTRI/2025/04/084066 [Registered on: 03/04/2025] Trial Registered Prospectively
Last Modified On: 31/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The application of amniotic membrane as a biological dressing for the treatment of non- healing foot wound in patients with type 2 diabetes mellitus in comparison with application of conventional saline dressings.  
Scientific Title of Study   To compare the efficacy of amniotic membrane as the biological dressing versus conventional saline dressing in management of lower limb diabetes related foot ulcer.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PRAVEEN RICHARD T  
Designation  JUNIOR RESIDENT  
Affiliation  CHRISTIAN MEDICAL COLLEGE VELLORE 
Address  DEPARTMENT OF PMR CHRISTIAN MEDICAL COLLEGE VELLORE TAMILNADU SOUTH INDIA

Vellore
TAMIL NADU
632002
India 
Phone  6381080563  
Fax    
Email  praveenrichard95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Bobeena Rachel Chandy 
Designation  PROFESSOR 
Affiliation  CHRISTIAN MEDICAL COLLEGE VELLORECHRISTIAN MEDICAL COLLEGE VELLORE 
Address  DEPARTMENT OF PMR CHRISTIAN MEDICAL COLLEGE VELLORE TAMILNADU SOUTH INDIA

Vellore
TAMIL NADU
632002
India 
Phone  04162285274  
Fax    
Email  bobeenachandy@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Bobeena Rachel Chandy 
Designation  PROFESSOR 
Affiliation  CHRISTIAN MEDICAL COLLEGE VELLORECHRISTIAN MEDICAL COLLEGE VELLORE 
Address  DEPARTMENT OF PMR CHRISTIAN MEDICAL COLLEGE VELLORE TAMILNADU SOUTH INDIA

Vellore
TAMIL NADU
632002
India 
Phone  04162285274  
Fax    
Email  bobeenachandy@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
CHRISTIAN MEDICAL COLLEGE VELLORE  
 
Primary Sponsor  
Name  PRAVEEN RICHARD T  
Address  DEPARTMENT OF PMR CHRISTIAN MEDICAL COLLEGE VELLORE PIN 632002 TAMILNADU SOUTH INDIA 
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 
PRAVEEN RICHARD   CHRISTIAN MEDICAL COLLEGE VELLORE  DEPARTMENT OF PMR CHRISTIAN MEDICAL COLLEGE
Vellore
TAMIL NADU 
6381080563

dr.praveenrichard95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL REVIEW BOARD   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, (2) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Amniotic Membrane  Application of amniotic membrane obtained from the placenta as a dressing for diabetic foot ulcers. 
Comparator Agent  Conventional saline dressings  Application of conventional dressing with normal saline in diabetic foot ulcer. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1 Patients with Type 2 DM with a diabetic foot ulcer
2 Age greater than 18 years
3 Patients are willing to follow up for 4 weeks
4 Diabetic foot ulcer involving epidermis, dermis, and subcutaneous tissue, muscle only but not bone.  
 
ExclusionCriteria 
Details  1)Presence of underlying osteomyelitis.
2) Presence of necrotizing soft tissue infection.
3) Hypoalbuminemia (albumin less than 2gm%).
4) Anemia (Hb less than 8 gm%).
5) Patient should not be any antibiotics for a systemic illness.
6) Patients with chronic kidney disease or known decompensated liver disease non-diabetes-related foot ulcers.
7) Ulcers with sinus. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in the size (area) of the diabetic foot ulcers   4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the change in PUSH score. To compare the pain scale VAS score. Type of granulation tissue.   4weeks 
 
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)   01/05/2025 
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="0"
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  

Lower limb Diabetes-related foot ulcer (DFU) is a major complication of diabetes causing significant morbidity and mortality all over the world. Depending on the nature and extent of the wound, the healing process may take up to 6 to 12 months or sometimes even longer.  The treatment of DFU remains complex, with the primary aim being offloading (pressure relief), with the Total contact casting (TCC), orthosis or using modified footwear.  In our department, the standard of care is TCC and the use of Bohler iron in clean ulcers which allows the mobility of the patient with total offloading.   A new method of treatment for DFU that we propose is the use of amniotic membrane as a biological dressing .   Patients with chronic diabetic foot ulcer attending the PMR OPD and integrated diabetic foot clinic will be recruited for the study. Patients who consent for the study will be randomized using Computer generated randomization to allocate each patient into control group and interventional group. Both the groups will be given the current standard casting with bohler iron with Total contact casting as the complete offloading technique.  Casting with bohler iron will be done in both the groups on day 1,11, and day21 .  A window will be made at the site of the DFU site for both the groups and regular saline dressing will be done daily for the control arm. For the intervention arm, Placenta will be procured from the labor room in CMC hospital and the amniotic membrane will be separated and prepared. This biological dressing will be applied on the ulcers of the participants recruited in the interventional arm at day 1,11 and day 21 of the study. A sterile op-site over the bohler iron will be applied over the cast of the participants in the interventional group after the application of amniotic membrane in order to prevent infection while travel to their homes/lodge. Two photographs of the DFU will be taken for both the groups, first on day 1 prior to casting, third during post cast removal on day 30. All photograph will be analyzed by the image software CATER  (Center for Advanced Technology Enabled rehabilitation) created by the Department of PMR and the accurate size and the area of the ulcers of the control and interventional group will be compared. Appropriate descriptive and analytical statistics will be done to establish the study objectives.

 
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