Health Condition 1: L984- Non-pressure chronic ulcer of skin, not elsewhere classified Health Condition 2: L896- Pressure ulcer of heel Health Condition 3: L989- Disorder of the skin and subcutaneous tissue, unspecified Health Condition 4: E116- Type 2 diabetes mellitus with other specified complications Health Condition 5: E106- Type 1 diabetes mellitus with other specified complications Health Condition 6: E108- Type 1 diabetes mellitus with unspecified complications Health Condition 7: L896-
Conditions
Interventions
Intervention1: ionotropically crosslinked bioactive superabsorbable antimicrobial dressings: Participants will be first screened based on inclusion criteria
the considered patient will then be considered for the intervention group.
Participants allocated to the intervention group will receive the superabsorbent dressing for wound ulcers once in a week fo
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 18 years and above, diagnosis of chronic wounds confirmed by clinical assessment and medical records, wound size exceeding a certain predefined threshold (e.g., greater than 1 cm2) to ensure an adequate sample for evaluation, ability to provide informed consent or consent provided by a legally authorized representative, willingness to comply with the study protocol and follow-up visits, availability for the duration of the study period.
Exclusion criteria
Exclusion criteria: 1. Acute wounds or wounds expected to heal within the next 4 weeks. 2. Participants with deep wound including bone necrosis. 3. Wound size exceeding a certain predefined threshold (e.g., greater than 6 cm2 horizontally, 3 cm in depth) to ensure an adequate sample for evaluation. 4. Allergy or known sensitivity to components of the super absorbent dressing. 5. Presence of untreated infection at the wound site. 6. Concomitant use of other wound dressings or treatments that may interfere with the evaluation of the study intervention. 7. Participation in another clinical trial involving wound care interventions concurrently or within the past month. 8. Conditions that may compromise wound healing, such as uncontrolled peripheral vascular disease, or systemic immunosuppression. 9. Pregnancy or lactation 10. Known non-compliance with medical treatment or follow-up appointments. 11. Presence of malignancy at or near the wound site. 12. Any condition or circumstance that, in the opinion of the investigator, may interfere with the safety of the participant or the conduct of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Physical examination of wounds a. Wound area: surface area in cm² (using opsite flexigrid mapping) and depth in mm. b. Wound bed assessment as per the TIMES acronym of NHS standards (Ref) c. Pain (VAS scale), temperature and color 2. Clinical outcomes and estimation of associated biomarkers a. reduction in ulcer size b. Complete wound closure c. Decrease in pain intensity d. Reduction in infection and inflammation e. Minimize scar formation f. Improvement in Quality of LifeTimepoint: Baseline and follow-up will be after 15 days and 45 days | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactProf Santanu Dhara
Datta Meghe Institute of Higher Education and Research
Outcome results
None listed