| CTRI Number |
CTRI/2025/04/084066 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
31/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The application of amniotic membrane as a biological dressing for the treatment of non- healing foot wound in patients with type 2 diabetes mellitus in comparison with application of conventional saline dressings.
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Scientific Title of Study
|
To compare the efficacy of amniotic membrane as the biological dressing versus conventional saline dressing in management of lower limb diabetes related foot ulcer.
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| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRAVEEN RICHARD T |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE VELLORE |
| Address |
DEPARTMENT OF PMR
CHRISTIAN MEDICAL COLLEGE
VELLORE
TAMILNADU SOUTH INDIA
Vellore TAMIL NADU 632002 India |
| Phone |
6381080563 |
| Fax |
|
| Email |
praveenrichard95@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Bobeena Rachel Chandy |
| Designation |
PROFESSOR |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE VELLORECHRISTIAN MEDICAL COLLEGE VELLORE |
| Address |
DEPARTMENT OF PMR
CHRISTIAN MEDICAL COLLEGE
VELLORE
TAMILNADU SOUTH INDIA
Vellore TAMIL NADU 632002 India |
| Phone |
04162285274 |
| Fax |
|
| Email |
bobeenachandy@cmcvellore.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Bobeena Rachel Chandy |
| Designation |
PROFESSOR |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE VELLORECHRISTIAN MEDICAL COLLEGE VELLORE |
| Address |
DEPARTMENT OF PMR
CHRISTIAN MEDICAL COLLEGE
VELLORE
TAMILNADU SOUTH INDIA
Vellore TAMIL NADU 632002 India |
| Phone |
04162285274 |
| Fax |
|
| Email |
bobeenachandy@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| CHRISTIAN MEDICAL COLLEGE VELLORE |
|
|
Primary Sponsor
|
| Name |
PRAVEEN RICHARD T |
| Address |
DEPARTMENT OF PMR
CHRISTIAN MEDICAL COLLEGE
VELLORE PIN 632002
TAMILNADU SOUTH INDIA |
| Type of Sponsor |
Other [self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| PRAVEEN RICHARD |
CHRISTIAN MEDICAL COLLEGE VELLORE |
DEPARTMENT OF PMR
CHRISTIAN MEDICAL COLLEGE
Vellore TAMIL NADU |
6381080563
dr.praveenrichard95@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, (2) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amniotic Membrane |
Application of amniotic membrane obtained from the placenta as a dressing for diabetic foot ulcers. |
| Comparator Agent |
Conventional saline dressings |
Application of conventional dressing with normal saline in diabetic foot ulcer. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients with Type 2 DM with a diabetic foot ulcer
2 Age greater than 18 years
3 Patients are willing to follow up for 4 weeks
4 Diabetic foot ulcer involving epidermis, dermis, and subcutaneous tissue, muscle only but not bone. |
|
| ExclusionCriteria |
| Details |
1)Presence of underlying osteomyelitis.
2) Presence of necrotizing soft tissue infection.
3) Hypoalbuminemia (albumin less than 2gm%).
4) Anemia (Hb less than 8 gm%).
5) Patient should not be any antibiotics for a systemic illness.
6) Patients with chronic kidney disease or known decompensated liver disease non-diabetes-related foot ulcers.
7) Ulcers with sinus. |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the size (area) of the diabetic foot ulcers |
4 weeks |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the change in PUSH score. To compare the pain scale VAS score. Type of granulation tissue. |
4weeks |
|
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Target Sample Size
|
Total Sample Size="34" Sample Size from India="34"
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)
|
01/05/2025 |
| 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="1" 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
|
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Brief Summary
|
Lower limb Diabetes-related foot ulcer (DFU) is a major complication of diabetes causing significant morbidity and mortality all over the world. Depending on the nature and extent of the wound, the healing process may take up to 6 to 12 months or sometimes even longer. The treatment of DFU remains complex, with the primary aim being offloading (pressure relief), with the Total contact casting (TCC), orthosis or using modified footwear. In our department, the standard of care is TCC and the use of Bohler iron in clean ulcers which allows the mobility of the patient with total offloading. A new method of treatment for DFU that we propose is the use of amniotic membrane as a biological dressing . Patients with chronic diabetic foot ulcer attending the PMR OPD and integrated diabetic foot clinic will be recruited for the study. Patients who consent for the study will be randomized using Computer generated randomization to allocate each patient into control group and interventional group. Both the groups will be given the current standard casting with bohler iron with Total contact casting as the complete offloading technique. Casting with bohler iron will be done in both the groups on day 1,11, and day21 . A window will be made at the site of the DFU site for both the groups and regular saline dressing will be done daily for the control arm. For the intervention arm, Placenta will be procured from the labor room in CMC hospital and the amniotic membrane will be separated and prepared. This biological dressing will be applied on the ulcers of the participants recruited in the interventional arm at day 1,11 and day 21 of the study. A sterile op-site over the bohler iron will be applied over the cast of the participants in the interventional group after the application of amniotic membrane in order to prevent infection while travel to their homes/lodge. Two photographs of the DFU will be taken for both the groups, first on day 1 prior to casting, third during post cast removal on day 30. All photograph will be analyzed by the image software CATER (Center for Advanced Technology Enabled rehabilitation) created by the Department of PMR and the accurate size and the area of the ulcers of the control and interventional group will be compared. Appropriate descriptive and analytical statistics will be done to establish the study objectives. |