| 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
|
|
|
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
|
|
|
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. |