Health Condition 1: E08-E13- Diabetes mellitus
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Saveetha Medical College and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage reduction in wound areaTimepoint: Day 0 Week 2 Week 4 Week 8 and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 visitTimepoint: Day 0 Week 2 Week 4 Week 8 and Week 12 | — |
Countries
India
Contacts
Public ContactDR S NIMITHAP
SAVEETHA MEDICAL COLLEGE AND HOSPITAL
Outcome results
None listed