| CTRI Number |
CTRI/2025/11/096985 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
06/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to find out if the STASI™ sponge can better stop bleeding after cleaning diabetic foot wounds compared to regular gauze in people taking blood-thinning medicines |
|
Scientific Title of Study
|
Prospective, Randomized, Investigator Initiated, Controlled Study to determine Haemostatic Efficacy
of STASITM Non-Absorbable Sponge to control bleeding after debridement of Diabetic Foot Ulcers as
compared to sterile gauze in patients taking Anticoagulants |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol Number -INV-25-001 Version 01 dated 28 Aug 25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajat K Engineer |
| Designation |
Principal Investigator |
| Affiliation |
Shraddha Multispeciality Hopsital |
| Address |
Shraddha Multispeciality Hopsital, Department of Surgery First floor Vaibhav Complex, Kalol
Gandhinagar
GUJARAT
382721
India |
| Phone |
02764221222 |
| Fax |
|
| Email |
drrajatengineer8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajat K Engineer |
| Designation |
Principal Investigator |
| Affiliation |
Shraddha Multispeciality Hopsital |
| Address |
Shraddha Multispeciality Hopsital, Department of Surgery First floor Vaibhav Complex, Kalol
GUJARAT
382721
India |
| Phone |
02764221222 |
| Fax |
|
| Email |
drrajatengineer8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajat K Engineer |
| Designation |
Principal Investigator |
| Affiliation |
Shraddha Multispeciality Hopsital |
| Address |
Shraddha Multispeciality Hopsital, Department of Surgery First floor Vaibhav Complex, Kalol
GUJARAT
382721
India |
| Phone |
02764221222 |
| Fax |
|
| Email |
drrajatengineer8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shraddha Multispeciality Hopsital, Vaibhav Complex, Kalol dist Gandhinagar, GUJARAT 382721
India |
|
|
Primary Sponsor
|
| Name |
Dr Rajat Engineer |
| Address |
Shraddha Multispeciality Hopsital, Vaibhav Complex, Kalol, Gandhinagar,GUJARAT,382721
India |
| Type of Sponsor |
Other [Self] |
|
|
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 Rajat Engineer |
Shradhha Multipsepciality Hospital |
First Floor, Department of Sugery
Shraddha Multispeciality Hopsital, Vaibhav Complex, Kalol
Gandhinagar
GUJARAT |
02764221222
drrajatengineer8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KKMH Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L974||Non-pressure chronic ulcer of heeland midfoot, (2) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard sterilized dry gauze. |
Haemostasis will be assessed at 5 and 10 minutes post-dressing, with treatment deemed successful if bleeding stops without additional measures within 10 minutes. |
| Intervention |
STASITM Non-Absorbable Sponge |
Haemostasis will be assessed at 5 and 10 minutes post-dressing, with treatment deemed successful if bleeding stops without additional measures within 10 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
- Adults male or female subjects aged 18 years and above with type I or II diabetes mellitus.
- Ulcer classified as Wagner grade I or II ulcers (more than 2 cm in diameter size and less than 10cm, and a duration of more than 6 weeks).
- Patients with good extremity circulation status, palpable pulse or confirmation with doppler sonography at the ankle (dorsalis pedis artery or posterior tibial artery).
- Received anticoagulation therapy due to diabetic vasculopathy or systemic disease.
- Patients with ability to understand and provide written, signed and dated informed consent form, which must have been obtained prior to screening.
- Patients willing to comply with the protocol requirements.
|
|
| ExclusionCriteria |
| Details |
- Hypersensitivity to STASITM Non-Absorbable Sponge or other components.
- Pregnant or lactating women.
- Patients undergoing Immunosuppressant therapy or systemic cardiopulmonary disease.
- Refusal or inability to provide consent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients in each group achieving complete haemostasis at 10 minutes after dressing application, without the need for additional interventions |
10 mins after application |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- Proportion of patients achieving complete haemostasis at 5 minutes
- Percentage of patients experiencing complications defined as rebleeding of hematoma
|
5 min and 10 mins after application |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
24/11/2025 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 investigator-initiated, prospective, randomized, controlled study evaluates the haemostatic efficacy and safety of STASI™ Non-Absorbable Sponge versus standard sterile gauze in controlling bleeding after minor debridement of diabetic foot ulcers in patients receiving anticoagulant therapy. Conducted at Shraddha Multispecialty Hospital, Gujarat, the trial will enroll 20 adult patients randomized 1:1 into study and control arms. Haemostasis will be assessed at 5 and 10 minutes post-application, with success defined as cessation of bleeding without additional measures within 10 minutes. Follow-up on Day 7 ± 1 will evaluate adverse events, ulcer healing, rebleeding, or hematoma formation. |