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CTRI Number  CTRI/2024/10/075076 [Registered on: 10/10/2024] Trial Registered Prospectively
Last Modified On: 03/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Study to evaluate effectiveness of cream for participants with diabetic foot ulcers and bedsores. 
Scientific Title of Study   An open-label, non-interventional, observational study of Human Placental extract Cream in patients with diabetic foot ulcers and bedsores across tertiary care centers. 
Trial Acronym  NIL 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
CT-CE-ADD-24 Version 1.0 Dated 26 Jun 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Veena Venkatesh 
Designation  Deputy General Manager-Medical Services 
Affiliation  Albert David Limited 
Address  Albert David Limited, Block-D, 3rd Floor, Gillander House, 8, Netaji Subhas Road, Kolkata, 700001(WB), India
NIL
Kolkata
WEST BENGAL
700001
India 
Phone  9930321184  
Fax    
Email  veena.venkatesh@adlindia.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Veena Venkatesh 
Designation  Deputy General Manager-Medical Services 
Affiliation  Albert David Limited 
Address  Albert David Limited, Block-D, 3rd Floor, Gillander House, 8, Netaji Subhas Road, Kolkata, 700001(WB), India
NIL
Kolkata
WEST BENGAL
700001
India 
Phone  9930321184  
Fax    
Email  veena.venkatesh@adlindia.in  
 
Details of Contact Person
Public Query  
Name  Dr Ashwini Kumar 
Designation  CEO 
Affiliation  CliniExperts Research Services Pvt. Ltd. 
Address  Unit No. 325, City Centre Mall, Plot No. 5, Sector 12, Dwarka, New Delhi – 110075
NIL
New Delhi
DELHI
110075
India 
Phone  7672005050  
Fax    
Email  ashwini.kumar@cliniexpertsresearch.com  
 
Source of Monetary or Material Support  
Albert David Limited 
 
Primary Sponsor  
Name  Albert David Limited 
Address  Block-D, 3rd Floor, Gillander House, 8, Netaji Subhas Road, Kolkata, 700001(WB), India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ambrish C  Medstar Speciality Hospital  OPD Room no 1, Clinical research department, 2nd floor, 641/17/1/3, Medstar Speciality Hospital, Kodigehalli Main Rd, Shanthivana, Sahakarnagar, Bengaluru, Karnataka 560092
Bangalore
KARNATAKA 		 9845895911

drambrishmedstar@gmail.com 
Dr Varadarajulu Reginald  SRV Agadi Hospital and Research Centre  Room no 109, Clinical research Department, 35 H, Siddaiah Rd, Vinayaka Nagar, Shamana Garden, Wilson Garden, Bengaluru, Karnataka 560027
Bangalore
KARNATAKA 		 80-41127524

varadarajuludr.medstar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Medstar Speciality Hospital Ethics Committee  Approved 
Medstar Speciality Hospital Ethics Committee  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Placentrex cream  Topical 10% Human placental extract Cream Frequency: 2 times daily for a period of 12 weeks. Administration: Topical. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Subjects aged between 40-70 years of any sex.
2. Subjects clinically diagnosed with diabetic foot ulcers and bedsores with wounds of more than two weeks duration.
3. Subjects with diabetic foot ulcers having an area not more than 5cm squire of area of ulcer and of more than six weeks duration
4. Diabetic foot ulcers ulcer should be free of necrotic debris, foreign bodies, sinus tracts, tunnelling, and undermining.
5. Subjects with bedsores having an area not more than 3 cm squire of area of ulcer.
6. The diabetic foot ulcers had to be clinically noninfected (Infection will be diagnosed based on clinical signs and symptoms)
7. Subjects with bedsores with wounds of more than 1 to 2 weeks duration.
8. Subjects willing for informed consent.
9. Subjects willing for regular follow up.
10. Women of childbearing age should not be pregnant or lactating. 
 
ExclusionCriteria 
Details  1. Pregnancy and lactating mothers
2. Pediatric subjects (less than 18 years of age).
3. Subjects with diabetic foot ulcers having an area more than 5×5 cm of area of ulcer, full thickness and exposure of bone, muscle, ligaments, or tendons.
4. Subjects with chronic CVD (Coronary/Cerebro Vascular Disease), CKD - stages III and IV.
5. Ulcers with malignant aetiologies.
6. Subjects who require hospitalization.
7. Subject with history of active ulcer, active arthropathy or foot infection.
8. Subjects not willing to participate in the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Response to treatment is measured by percentage of patients with
wound healing in the wound area.
The following parameters should be considered for assessment of
wound healing: Principal Investigator will assess the wound healing
by visual inspection of wound at baseline and end of the study.
1. Healthy granulation tissue,
2. Absence of pus/necrotic tissue,
3. Absence of bleeding while dressing,
4. Presence of Scar tissue,
5. Absence of surrounding skin
discoloration/atrophic changes 		 Duration of 4 weeks. Visit 1, Visit 2, Visit 3, Visit 4. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Safety Assessment
2. Tolerability assessment
3. Percentage reduction in the wound area
4. Time taken for wound healing 		 Duration of 4 weeks. Visit 1, Visit 2, Visit 3, Visit 4. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Phase 4 
Date of First Enrollment (India)   14/10/2024 
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="0"
Months="6"
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 - NO
Brief Summary   In a pioneering observational study, 100 participants with diabetic foot ulcers or bedsores will be observed over 12 weeks at tertiary care centers. After informed consent, 60 subjects with diabetic foot ulcers and 40 with bedsores will undergo thorough physical and wound examinations, alongside laboratory tests. Wound characteristics, including size, type, redness, infection, inflammation, slough, vascular insufficiencies, and atrophy signs, will be meticulously recorded. Wound dimensions will be measured using translucent graph paper, and baseline photographs will be taken. Subjects will apply a topical Cream twice daily after cleaning wounds with povidone iodine. Healing will be visually assessed at baseline and study’s end, with photographs documenting progress. Participants, aged 40-70, must have wounds persisting for over two weeks, meet specific size criteria, and exhibit no signs of infection. The study aims to measure wound healing percentage, safety, tolerability, and healing time, with evaluations at weeks 4, 8, and 12. Treatment response will be gauged by wound size reduction, healthy tissue, absence of pus or necrosis, no bleeding during dressing, scar formation, and lack of skin discoloration or atrophy. Adverse events and other care aspects will also be monitored to ensure safety and efficacy. 
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