| CTRI Number |
CTRI/2025/08/093680 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARISON OF EFFICACY OF FETAL MEMBRANES AND COLLAGEN POWDER FOR THE HEALING OF NON HEALING ULCERS .
|
|
Scientific Title of Study
|
COMPARISON OF EFFICACY OF AMNIOTIC MEMRANE AND COLLAGEN POWDER FOR THE HEALING OF CHRONIC NON HEALING ULCERS .
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lakshmi S S |
| Designation |
Senior resident |
| Affiliation |
Government medical college kozhikode |
| Address |
Department Of Physical Medicine and Rehabilitation
Government medical college
Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
7907098378 |
| Fax |
|
| Email |
lakshmisstvm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lakshmi S S |
| Designation |
Senior Resident |
| Affiliation |
government medical college kozhikode |
| Address |
Department Of Physical Medicine and Rehabilitation
Government Medical College
Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
7907098378 |
| Fax |
|
| Email |
lakshmisstvm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
LAKSHMI S S |
| Designation |
Senior resident |
| Affiliation |
government medical college kozhikode |
| Address |
Department of Physical Medicine and Rehabilitation
Government Medical College
Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
7907098378 |
| Fax |
|
| Email |
lakshmisstvm@gmail.com |
|
|
Source of Monetary or Material Support
|
| government medical college kozhikode |
|
|
Primary Sponsor
|
| Name |
government medical college kozhikode |
| Address |
depatment of physical medicine and rehabilitation
government medical colledge kozhikode |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Roy R Chandran |
Department of Physical Medicine and Rehabilitation |
Governnment Medical College Kozhikode
Kozhikode
KERALA |
9947754094
royramachandran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T07||Unspecified multiple injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
amniotic membrane |
one set of chronic ulcer patients recieved amniotic membrane dressing for chronic ulcers |
| Comparator Agent |
collagen powder |
another set of patients with chronic ulcers recieved collagen powder as treatment. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients with chronic ulcers more than 6 weeks attending PMR OPD.
2 Sterile ulcers. |
|
| ExclusionCriteria |
| Details |
1 Infected ulcers
2 Underlying osteomyelitis
3 Ulcers with exposed tendons and bones |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1 Ulcer dimensions in length ,width and circumference. |
Baseline, one,four,eight weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
05/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/09/2025 |
| 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 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
|
Introduction
Chronic non healing ulcers are a major cause of morbidity among Indian Population This study aims to compare two unique techniques of healing chronic ulcer - amniotic memrane and collagen powder.
METHODOLOGY
By using randomised control trial chronic ulcer patients recieved either amniotic membrane or collagen powder as treatment and outcomes were analysed using ulcer dimensions and VAS for pain at baseline ,one,four,eight weeks.
IMPLICATION
The two techiniques used are safe and cheap alternative to the other commmerciallly available expensive dressings in market. |