Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
Intervention1: Topical Esmolol: Esmolol Hydrochloride 14% w/w gel is a topical beta-adrenergic receptor blocker formulated to enhance wound healing in diabetic foot ulcers (DFUs). When applied directl
Sponsors
KLE College of Pharmacy, Belagavi - 590010
Eligibility
Inclusion criteria
Inclusion criteria: Subjects aged 18 to 95 years, inclusive, with Type 1 or Type 2 diabetes undergoing therapy for glycemic control. Subjects having below knee ulcer of at least 4 week and maximum of 52 weeks duration which is a full thickness ulcer without exposure of bone, muscle, ligaments, or tendons. Ulcer should be clinically non-infected. Ulcer area (length x width) measurement between 1.5 cm and 10 cm , inclusive and post debridement ulcer area less than or equal to 12 cm . Full-thickness ulcer of Grade 1 or Grade 2 as per Wagner classification system. Recently debrided ulcer (2 weeks prior to screening) and post debridement ulcer free of necrotic debris, foreign bodies, sinus tracts, tunneling, and undermining, comprised of healthy vascularized tissue as determined by the Investigator. Ankle Brachial index between 0.7 and 1.2.
Exclusion criteria
Exclusion criteria: Actively infected ulcers with purulent discharge, ulcers with exposed bone or associated with osteomyelitis. Subjects having cellulitis, ischemic or gangrenous ulcers in the opinion of the Investigator. Glycosylated hemoglobin (HbA1c) more than or equal to 12 percent. Diagnosed and/ currently unstable hypotension, heart block, cardiac failure, and other cardiac complications. Subject diagnosed with cancer undergoing chemotherapy Revascularization surgery 4 weeks prior to signing the ICF Renal failure as defined by serum creatinine less than 3.0 mg/dL or renal insufficiency requiring frequent dialysis Poor nutritional status as measured by serum albumin more than 3.0 g/dL Active Charcot or other structural deformity that would prevent adequate off-loading of the study foot
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the change in wound area of uninfected DUs of diabetic patients admitted to tertiary care hospital within 3-week Treatment Phase upon application of topical esmolol plus Standard of Care as against only Standard of Care treatmentTimepoint: Baseline (Day 0): Capture initial wound area before treatment starts for comparison. Week 1 (Day 7): Early assessment to monitor initial response to treatment. Week 2 (Day 14): Intermediate assessment during the treatment phase to track progress. Week 3 (Day 21): End of treatment phase assessment to evaluate primary outcome of wound area change. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the duration of change in wound area of uninfected DUs of diabetic patients admitted to tertiary care hospital within 3-week Treatment Phase upon application of topical esmolol plus Standard of Care as against only Standard of Care treatment.Timepoint: Baseline (Day 0): Initial measurement of wound area to establish starting point. Week 1 (Day 7): Early assessment to observe initial wound area changes and onset of treatment effect. Week 2 (Day 14): Mid-treatment phase evaluation to monitor progression or regression of wound healing. Week 3 (Day 21, end of treatment phase): To assess extent of wound area change by completion of treatment. Follow-up post-treatment (Week 4 or later): To determine the sustainability or duration of wound healing response after stopping treatment (e.g., Day 28 or Week 6) | — |
Countries
India
Contacts
Public ContactDr Shashikala C Wali
KLE Society College of Pharmacy
Outcome results
None listed