| CTRI Number |
CTRI/2023/04/051654 [Registered on: 17/04/2023] Trial Registered Prospectively |
| Last Modified On: |
03/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of platelet rich plasma and silver ion dressing on venous ulcer healing |
|
Scientific Title of Study
|
A single blind randomized controlled clinical study comparing the efficacy of platelet-rich plasma (PRP) and silver ion dressing on venous ulcer healing |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Seema Khanna |
| Designation |
Professor & Head, Department of General Surgery |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of General Surgery
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8318332113 |
| Fax |
|
| Email |
seemakhanna119@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Seema Khanna |
| Designation |
Professor & Head, Department of General Surgery |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of General Surgery
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8318332113 |
| Fax |
|
| Email |
seemakhanna119@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajat Jangir |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Room 408, Shushrut Hostel, Trauma centre, BHU, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9602721301 |
| Fax |
|
| Email |
rajatramniwas@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institute of medical sciences |
| Address |
Department of General Surgery
Institute of medical sciences
Banaras hindu university, Varanasi |
| 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 |
| Prof Seema Khanna |
Sir Sunder Lal Hospital |
UNIT- E, General Surgery Ward
Varanasi
UTTAR PRADESH |
8318332113
seemakhanna119@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Platelet Rich Plasma (PRP) on venous ulcer |
Topical application of autologous platelet rich plasma (PRP) on venous ulcer per week for 6 weeks |
| Comparator Agent |
Silver ion dressing |
Silver ion dressing on venous ulcer per week for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Venous leg ulcer with ABPI more than 0.8 with normal platelet count.
2. VLU grading 0-5A & 6A ( according to modified TIME-H score). |
|
| ExclusionCriteria |
| Details |
1. Modified TIME-H score [5B & 6B-8 (healing unlikely)
2. VLU area > 100sq cm
3. Immune-compromised
4. Coagulation disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| comparing effect of topical platelet rich plasma and silver ion on venous ulcer healing |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in pain score |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/04/2023 |
| Date of Study Completion (India) |
01/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/07/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Venous ulcer is a common public health problem. Venous leg ulcer healing process is complex as it affects both macro and micro vasculature. Autologous platelet rich plasma being a rich source of growth factors, may be effective. It is safe, easy to prepare and cost effective. On the other hand the microbicidal action of silver ions has also been tried for ulcer healing. In our study patients with venous leg ulcer will be treated by topical application of PRP and silver ion dressing and the rate of ulcer healing compared over a duration of 6 weeks. Quality of life assessment will also be done by the use of Aberdeen varicose vein questionnaire. |