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CTRI Number  CTRI/2024/12/078059 [Registered on: 12/12/2024] Trial Registered Prospectively
Last Modified On: 11/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Skin protectant gel]  
Study Design  Single Arm Study 
Public Title of Study   Soreze Advance Gel for treatment of Pressure Ulcer Healing and Wound Care in Adult Subjects 
Scientific Title of Study   A phase-IV, Open-Label, interventional, prospective, single arm Trial of Soreze Advance Gel for treatment of Pressure Ulcer Healing and Wound Care in Adult Subjects 
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 Rakesh verma 
Designation  Assistant professor 
Affiliation  Jawahar Lal Nehru Medical College 
Address  Department of Orthopedics Jawahar Lal Nehru Medical College Kala Bagh

Ajmer
RAJASTHAN
305001
India 
Phone  9460077585  
Fax    
Email  rakeshverma.jln@outlook.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rakesh verma 
Designation  Assistant professor 
Affiliation  Jawahar Lal Nehru Medical College 
Address  Department of Orthopedics Jawahar Lal Nehru Medical College Kala Bagh

Ajmer
RAJASTHAN
305001
India 
Phone  9460077585  
Fax    
Email  rakeshverma.jln@outlook.com  
 
Details of Contact Person
Public Query  
Name  Dr Swati 
Designation  Clinical Operations Lead 
Affiliation  Sclin soft technologies private limited 
Address  12-5-35/A/6 Street 6 Secunderabad

Hyderabad
TELANGANA
500017
India 
Phone  9760147377  
Fax    
Email  swati@sclintech.com  
 
Source of Monetary or Material Support  
Amaterasu Life sciences LLP ,H 4-5, Floor-9TH, Plot-156, Everest apartments, Pandit madan mohan malviyamarg, Tardeo, mumbai, maharastra- 400034  
 
Primary Sponsor  
Name  Amaterasu Life sciences LLP 
Address  H 4-5, Floor-9TH, Plot-156, Everest apartments, Pandit madan mohan malviyamarg, Tardeo, mumbai, maharastra- 400034 
Type of Sponsor  Other [Innovation driven development of new topical/dermatological and injectable drug delivery system] 
 
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 Rakesh verma  Jawahar Lal Nehru medical college  Department of Orthopedics, Jawahar Lal Nehru Medical College, Kala Bagh,
Ajmer
RAJASTHAN 		 9460077585

rakeshverma.jln@outlook.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee (IEC) ,Jawaharlal Nehru Medical College & Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L899||Pressure ulcer of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Soreze Advance Gel  Soreze Advance Gel combines a natural recipe of herbs and essential oils with silicone elastomers that helps in healing of bedsores by forming a wound dressing that promotes moisture retention and wound healing. Soreze Advance Gel is a unique film forming wound dressing of traditional herbs and natural essential oils in silicone elastomers that locks moisture inside the wound. This product is to be applied for 42 days twice daily on ulcerated areas as well as other ulcer prone areas and allow it to dry for 1 min. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1)Subjects who are 18 years to 80 years of age (Both Years inclusive).
2)Patients who are willing and provide a signed, dated informed consent.
3)Patients who are available for follow-up.
4)The patient has one or more pressure ulcers (bedsores) (stage
II or Stage III). 
 
ExclusionCriteria 
Details  1)The patient participating in another study, or has participated
in another study in the last 28 days.
2)The patient is in an exclusion period determined by a previous
study.
3)The patient refuses to sign the consent.
4)The patient is pregnant, parturient, or breastfeeding.
5)Patient under curative anticoagulation.
6)Patient is a woman of child-bearing potential and does not
consent to or receive a screening urine pregnancy test prior to
study enrolment.
7)Patient has any wound that at enrolment is scheduled for
surgical closure within 14 days.
8)Patients having grade I & IV pressure ulcer.
9)Use of any immunosuppressant medications (for example,
cyclosporine, methylprednisolone, prednisone, methotrexate,
alefacept, or infliximab) within 30 days of screening.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare percentage change in ulcer size, stage, length, width, and depth in patients
with at least one of stage II or Stage III pressure ulcer in subjects  		 Visit-1, Visit-2, Visit-3, Visit-4, Visit-5, Visit-6, Visit-7 
 
Secondary Outcome  
Outcome  TimePoints 
1)To compare healing progress using the National Pressure Ulcer Advisory Panel’s
Pressure Ulcer Scale for Healing (PUSH) score and other indicators of wound healing
such as time to complete wound closure, elimination of signs of wound infection.
2)Safety and tolerability will be monitored by adverse events assessment (AEs and SAEs)
throughout the study period. 		 Visit-1, Visit-2, Visit-3, Visit-4, Visit-5, Visit-6, Visit-7 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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)   23/12/2024 
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="1"
Days="15" 
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   All patients meeting the inclusion criteria, with grade II and grade III ulcers, who sign the informed consent will be recruited for this single-arm, open-label study. Data on the primary endpoint, which is pressure ulcer size (stage, length, width, and depth), will be collected through clinician measurements and photographic documentation. Secondary endpoints will include infection status (including signs/symptoms of infection), amount and type of exudate, wound tissue color and type, and adverse events, all recorded at baseline. The wound surface area (length x width), exudate amount, and tissue type will be documented using the PUSH tool, and a baseline PUSH score will be calculated. Subjects will apply the investigational product twice daily, and information collected at each follow-up visit will include pressure ulcer size (length, width, depth via clinician measurement with photographic documentation), PUSH sub-scores and total score, time to complete wound closure, infection status, and adverse events. 
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