| CTRI Number |
CTRI/2024/05/066875 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2025 |
| Post Graduate Thesis |
|
| Type of Trial |
Observational |
|
Type of Study
|
investigator-initiated POC |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
An investigator-initiated POC Ph 2 study to evaluate the safety and efficacy of VT-1953 topical gel in advanced cancer patients with malodorous malignant fungating wounds.
|
Scientific Title of Study
Modification(s)
|
An investigator-initiated POC Ph 2 study to evaluate the safety and efficacy of VT-1953 topical gel in advanced cancer patients with malodorous malignant fungating wounds.
|
| Trial Acronym |
malignant fungating wounds. |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prashant P Lad |
| Designation |
MBBS,DNB(Gen.Surgery) |
| Affiliation |
Om Sai onco Surgery Center . |
| Address |
Om Sai onco Surgery Center R.S.no 457110 C Dr. Lad Colony Sugar Mill Corner main road Kasaba
Bawada Kolhapur Maharashtra India 4 I 6006
Om Sai onco Surgery Center R.S.no 457110 C Dr. Lad Colony Sugar Mill Corner main road Kasaba
Bawada Kolhapur Maharashtra India 4 I 6006
Kolhapur
MAHARASHTRA
416006
India |
| Phone |
8237772626 |
| Fax |
|
| Email |
omsaicr17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant P Lad |
| Designation |
MBBS,DNB(Gen.Surgery) |
| Affiliation |
Om Sai onco Surgery Center . |
| Address |
Om Sai onco Surgery Center R.S.no 457110 C Dr. Lad Colony Sugar Mill Corner main road Kasaba
Bawada Kolhapur Maharashtra India 4 I 6006
Om Sai onco Surgery Center R.S.no 457110 C Dr. Lad Colony Sugar Mill Corner main road Kasaba
Bawada Kolhapur Maharashtra India 4 I 6006
Kolhapur
MAHARASHTRA
416006
India |
| Phone |
8237772626 |
| Fax |
|
| Email |
omsaicr17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashant P Lad |
| Designation |
MBBS,DNB(Gen.Surgery) |
| Affiliation |
Om Sai onco Surgery Center . |
| Address |
Om Sai onco Surgery Center R.S.no 457110 C Dr. Lad Colony Sugar Mill Corner main road Kasaba
Bawada Kolhapur Maharashtra India 4 I 6006
Om Sai onco Surgery Center R.S.no 457110 C Dr. Lad Colony Sugar Mill Corner main road Kasaba
Bawada Kolhapur Maharashtra India 4 I 6006
Kolhapur
MAHARASHTRA
416006
India |
| Phone |
8237772626 |
| Fax |
|
| Email |
omsaicr17@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. Prashant Prakash Lad |
| Address |
Dr LAD Colony Sugar Mill Corner Main Road Kasaba Bawada Kolhapur Maharashtra 416006 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Dr Prashant P Lad |
Om Sai Onco Surgery multispeciality center |
Dr LAD Colony Sugar Mill Corner Main Road Kasaba Bawada Kolhapur Maharashtra 416006
Kolhapur
MAHARASHTRA |
8237772626
-
omsaicr17@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OmSaiOncoInstitutionalEthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
topical gel |
deoxyribonucleic acid gyrase/topoisomerase IV inhibitor and immunomodulatory agent |
|
|
Inclusion Criteria
|
| Age From |
9.00 Day(s) |
| Age To |
75.00 Day(s) |
| Gender |
Both |
| Details |
1 Male or female subjects aged above 9 years old with a diagnosis of malodorous malignant fungating wound malodor corresponding to 0,1 and 2 on the TELER odor scale where 0 Malodor detected upon entering room above 3m or above 10ft with dressing on 1 Malodor detected at above 2m above 3m between 6 to 10ft distance from patient with dressing on and 2 Malodor detected at 1m or arm s length to the patient with dressing on, as judged by the investigators
2 Signed informed consent for adults For subjects under 16 years of age a parent or legal guardian of each subject must provide written informed consent and sign the HIPAA form or equivalent if applicable, approved by the appropriate Institutional Review Board (IRB)/Ethical Committee (EC) Whenever practical and appropriate per local requirements a child’s assent should also be sought before inclusion into the study
3 An Eastern Cooperative Oncology Group (ECOG) performance status of ≤3;
4 An anticipated survival of above 3 months
|
|
| ExclusionCriteria |
| Details |
5 Patients who are likely to respond to chemotherapy or radiation therapy.
6 Patients with current bleeding in wounds.
7 Subjects currently being treated with any antibiotic for bacterial infections or suffering from any infection that may require systemic antibiotic.
8 Patient is above 9 years of age at the time of informed consent
9 Life expectancy of below 3 months.
10 The patient is not an appropriate candidate for participation in this clinical study for any other reason as deemed by the investigator.
11 Subjects with known hypersensitivity to fluoroquinolones
12 Patients with serious cardiovascular diseases hemodyscrasia predisposition to arrhythmias (eg QT-interval prolongation, uncorrected hypokalemia or hypomagnesemia, significant bradycardia)
13 Subjects who, in the opinion of the investigator, would be unable to adhere to the study protocol
14 Nursing mothers pregnant women
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
Blinding/Masking
Modification(s)
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Efficacy Endpoint:
1. Mean score of malodor associated with malignant fungating
wounds (scored by investigators) using a 6 point TELER
Scale on Day 14. |
Primary Efficacy Endpoint:
1. Mean score of malodor associated with malignant fungating
wounds (scored by investigators) using a 6 point TELER
Scale on Day 14. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Key Secondary Efficacy Endpoints:
5. Mean score of malodor scored by the patient at Day 7 and 14
using a TELER Component scale.
6. Mean score of malodor associated with malignant fungating
wounds (scored by investigators) using a 6-point TELER
Scale at Day 7. |
Key Secondary Efficacy Endpoints:
5. Mean score of malodor scored by the patient at Day 7 and 14
using a TELER Component scale.
6. Mean score of malodor associated with malignant fungating
wounds (scored by investigators) using a 6-point TELER
Scale at Day 7. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
20/07/2024 |
| Date of Study Completion (India) |
13/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is an open label, investigator-initiated study to evaluate the efficacy and safety of VT-1953 Topical Gel in advanced cancer patients with malodorous malignant fungating wounds. First 10 patients will receive VT-1953 while next 5 patients will receive Vehicle control. All subjects will be treated twice daily (BID) for 2 weeks. |