| CTRI Number |
CTRI/2026/03/105912 [Registered on: 11/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Novel Nano Hydrogel Therapy for Faster Healing of Diabetic Wounds |
|
Scientific Title of Study
|
Nano selenium and hybrid polymer incorporated nano hydrogel for Rapid diabetic wound healing activity |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR S NIMITHAP |
| Designation |
POST GRADUATE, GENERAL MEDICINE |
| Affiliation |
SAVEETHA MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai
Chennai
TAMIL NADU
602105
Chennai
TAMIL NADU
602105
India |
| Phone |
9489222682 |
| Fax |
|
| Email |
nimithap0001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ANANTHAKUMAR P K |
| Designation |
PROFESSOR, GENERAL MEDICINE |
| Affiliation |
SAVEETHA MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai
Chennai
TAMIL NADU
602105
Chennai
TAMIL NADU
602105
India |
| Phone |
|
| Fax |
|
| Email |
ananthakumarpk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR S NIMITHAP |
| Designation |
POST GRADUATE, GENERAL MEDICINE |
| Affiliation |
SAVEETHA MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai
Chennai
TAMIL NADU
602105
Chennai
TAMIL NADU
602105
India |
| Phone |
9489222682 |
| Fax |
|
| Email |
nimithap0001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospital
Saveetha Nagar, Thandalam, Chennai- 602105, Chennai, Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Saveetha Medical College and Hospital |
| Address |
Saveetha Nagar, Thandalam, Chennai- 602105, Chennai, Tamil Nadu |
| Type of Sponsor |
Private 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 |
| DR S NIMITHAP |
SAVEETHA MEDICAL COLLEGE AND HOSPITAL |
Department of General Medicine,330-345 ward
Saveetha Nagar, Thandalam, Chennai
TAMIL NADU 602105
Chennai
TAMIL NADU |
9489222682
nimithap0001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E08-E13||Diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18 and 75 years
Confirmed diagnosis of Type 2 Diabetes Mellitus
Presence of a chronic diabetic foot ulcer of duration greater than 4 weeks
Wagner Grade I or II diabetic foot ulcers
Ulcer size measuring 1 to 10 cm2 at baseline assessment
HbA1c less than or equal to 12 percent indicating manageable glycemic status |
|
| ExclusionCriteria |
| Details |
Wagner Grade III to V ulcers including deep infection gangrene or osteomyelitis
Non diabetic ulcers including venous arterial traumatic or malignant ulcers
Severe peripheral arterial disease defined as Ankle Brachial Index less than 0.8
Active systemic infection or sepsis
Known allergy to selenium or any hydrogel components
Chronic kidney disease stage IV or V |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage reduction in wound area |
Day 0 Week 2 Week 4 Week 8 and Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Rate of wound contraction assessed at Week 2 Week 4 Week 8 and Week 12
Change in wound infection status assessed at baseline and each follow up visit
Pain score using Visual Analog Scale assessed at baseline Week 2 Week 4 Week 8 and Week 12
Glycemic control assessed using HbA1c at baseline and Week 12
Inflammatory markers assessed at baseline and Week 12
Safety assessment including local irritation allergy or adverse reactions assessed at every visit |
Day 0 Week 2 Week 4 Week 8 and Week 12 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
26/03/2026 |
| 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="3"
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
|
Diabetic foot ulcers are a common and serious complication of Type 2 Diabetes Mellitus and are associated with delayed wound healing increased risk of infection and higher rates of hospitalization and amputation Persistent oxidative stress chronic inflammation and impaired angiogenesis play a key role in poor wound healing in diabetic patients Conventional wound dressings often fail to provide sustained therapeutic benefits This study aims to evaluate the safety and efficacy of a nano selenium and hybrid polymer incorporated nano hydrogel for rapid diabetic wound healing Selenium nanoparticles possess antioxidant anti inflammatory and antimicrobial properties which may reduce oxidative stress control infection and promote tissue regeneration The hybrid polymer nano hydrogel is designed to provide a moist wound environment controlled release of active components and enhanced biocompatibility This randomized controlled clinical study will include patients with Wagner Grade I and II diabetic foot ulcers The primary outcome will be percentage reduction in wound area and time to complete wound closure Secondary outcomes will include infection status pain score and safety assessment The study intends to determine whether the novel nano hydrogel formulation improves healing outcomes compared to standard wound care in diabetic patients |