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CTRI Number  CTRI/2025/08/093794 [Registered on: 27/08/2025] Trial Registered Prospectively
Last Modified On: 26/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [COLLAGEN POWDER APLLY LOCALLY OVER WOUND]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing collagen dressings and normal saline dressings for healing of chronic ulcers 
Scientific Title of Study   A comparative study of collagen based dressing versus normal saline dressing in chronic ulcers:A Randomized controlled trial. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ARQUAM BIN AFAQUE 
Designation  POST GRADUATE TRAINEE 
Affiliation  REGIONAL INSTITUTE OF MEDICAL SCIENCES IMPHAL MANIPUR  
Address  ROOM NO 109 POST GRADUATE HOSTEL NO 4 , LAMPHEL IMPHAL WEST MANIPUR

Imphal West
MANIPUR
795004
India 
Phone  9891593408  
Fax    
Email  ANAMAFAQUE@GMAIL.COM  
 
Details of Contact Person
Scientific Query
 
Name  DR CHETAN MAIBAM 
Designation  ASSOCIATE PROFESSOR DEPARTMENT OF GENERAL SURGERY RIMS IMPHAL 
Affiliation  REGIONAL INSTITUTE OF MEDICAL SCIENCES IMPHAL MANIPUR 
Address  DEPARTMENT OF GENERAL SURGERY RIMS,REGIONAL INSTITUTE OF MEDICAL SCIENCES LAMPHEL IMPHAL WEST MANIPUR

Imphal West
MANIPUR
795004
India 
Phone  9774524948  
Fax    
Email  cmaibam82@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR CHETAN MAIBAM 
Designation  ASSOCIATE PROFESSOR DEPARTMENT OF GENERAL SURGERY RIMS IMPHAL 
Affiliation  REGIONAL INSTITUTE OF MEDICAL SCIENCES IMPHAL MANIPUR 
Address  DEPARTMENT OF GENERAL SURGERY RIMS IMPHAL, REGIONAL INSTITUTE OF MEDICAL SCIENCES LAMPHEL IMPHAL WEST MANIPUR

Imphal West
MANIPUR
795004
India 
Phone  9774524948  
Fax    
Email  cmaibam82@gmail.com  
 
Source of Monetary or Material Support  
REGIONAL INSTITUTE OF MEDICAL SCIENCES LAMPHEL IMPHAL WEST MANIPUR INDIA 795004 
 
Primary Sponsor  
Name  ARQUAM BIN AFAQUE 
Address  ROOM NO 109 POST GRADUATE HOSTEL NO 4 RIMS IMPHAL MANIPUR 795004 
Type of Sponsor  Other [SELF SPONSORED BY PRINCIPAL INVESTIGAOR] 
 
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 
ARQUAM BIN AFAQUE  REGIONAL INSTITUTE OF MEDICAL SCIENCES   ROOM NO 3 ,SURGICAL WARD ,DEPARTMENT OF GENERAL SURGERY LAMPHELPAT IMPHAL WEST MANIPUR 795004
Imphal West
MANIPUR 
09891593408

ANAMAFAQUE@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RESEARCH ETHICS BOARD RIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L979||Non-pressure chronic ulcer of unspecified part of lower leg,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  COLLAGEN POWDER TYPE 1 BOVINE COLLAGEN  COLLAGEN POWDER COMES AS A BRAND NAME OF QUOROFIBRE MANUFACTURED BY DOCUSES HEALTHCARE INDIA PVT LTD.THE INTERVENTION WILL BE GIVE FOR THE DURATION OF 3 WEEKS 
Comparator Agent  NORMAL SALINE  NORMAL SALINE MANUFACTURED BY NIVY REMEDIES AVAILABLE IN THE SUPPLY AT RIMS IMPHAL.THE COMPARATOR AGENT WILL BE GIVE FOR THE DURATION OF 3 WEEKS 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. All patients with chronic ulcer of size 1 to 25 cm2
2. All chronic ulcers irrespective of aetiology viz. traumatic, infective ulcers, bedsores, burns, venous ulcers, diabetic ulcers, amputation stump ulcers, non-specific except arterial ulcers.
3. All patients above age of 18 years and both sexes
4. Patient with adequate blood supply to the limb (ankle-branchial index GREATER THAN 0.8)
 
 
ExclusionCriteria 
Details  1. Arterial ulcers.
2. Ulcers having exposed bone and tendons.
3. Ulcers with proven malignancy.
4. Patient on corticosteroids OR immune suppressants OR cancer chemotherapy.

5. Known allergy to collagen
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Percentage reduction in ulcer size  3 WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
Appearance of healthy granulation tissue  3weeks 
Requirement of skin grafting  4 weeks 
Time taken for complete healing of ulcer  6 weeks 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   10/09/2025 
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="2"
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  

This randomized controlled trial will be conducted in the Department of Surgery at the Regional Institute of Medical Sciences RIMS, Imphal, over a period of two years from August 2025 to August 2027. The study will focus on patients with chronic non-healing ulcers, recruiting a total of 72 participants 34 in each group who meet specific inclusion criteria such as having ulcers of size 1 to 25 cm2, being over 18 years of age, and willing to give informed consent. Ulcers of all etiologies except arterial will be included. Exclusion criteria comprise arterial ulcers, ulcers with exposed bone or tendons, malignancy, use of immunosuppressants or chemotherapy, and unwillingness to participate. Participants will be randomized into two groups using block randomization block size of 4, with sequence generation done by an external colleague via www.sealedenvelope.com. Allocation will be concealed using opaque sealed envelopes. Blinding will be maintained at both the patient and investigator levels. Group A will receive collagen granule dressings, while Group B will receive normal saline dressings. Both dressings will be administered by a surgeon not involved in the assessment to ensure blinding. Ulcers will be evaluated for key outcomes such as the appearance of healthy granulation tissue, time to 50% reduction in ulcer size, need for skin grafting, and total healing time. Measurements will be taken using sterile surgical tools including rulers and Vernier callipers on days 3, 5, 7, 10, 15, and 21. The data collected will be checked for accuracy and analysed using SPSS version 26.0. Categorical data will be assessed using the chi-square or Fisher’s exact test, while continuous data will be analysed with either the independent sample t-test or the Mann Whitney U test, with a significance level set at p less than 0.05. The study has sought ethical approval from the Research Ethics Board of RIMS, Imphal. Written informed consent will be obtained from all participants. Confidentiality will be maintained through coded data, which will be securely stored with access limited to the investigator and authorized personnel. This study aims to determine the comparative effectiveness of collagen granules versus normal saline in promoting healing in chronic ulcers.

 
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