Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: Esmolol Hydrochloride Gel 14% w/w: All enrolled trial participants will be instructed to apply the gel twice daily on wound surface area for a treatment duration of 12 weeks or until ul
Sponsors
Novalead pharma private limited
Ipca Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with HbA1c less than or equal to 12 percent 2. Type 1 or Type 2 diabetes patient undergoing therapy for glycemic control 3. Subject with diagnosis of neuropathic foot ulcer by 10g monofilament test 4. Subject has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index greater than or equal to 0.65 5. Ulcer is uninfected or mildly infected as per IWGDF or IDSA guidelines 6. Unresponsive to ulcer care and open for at least 6 weeks at the time of the Screening Visit 7. Ulcer is located below or up to 5cm above the malleoli excluding ulcers between the toes 8. Ulcer size is greater than or equal to 1 cm2 and less than or equal to 20 cm2 post debridement 9. There is a minimum 3 cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot, post debridement 10. No exposed bone, tendon, muscle, ligament or joint capsule, and no tunneling, undermining, or sinus tracts 11. Ulcer area reduction less than 20 percent from the Screening Visit to Baseline visit 12.Subject is able and willing to comply with study procedures and adhere to protocol during the study in the opinion of Investigator 13. A Subject or LAR agrees to sign informed consent form
Exclusion criteria
Exclusion criteria: 1. Deeply infected ulcers with exposed bone or associated with osteomyelitis 2. Subjects who are systemically well and metabolically stable but also has 1 or more ulcer characteristics of cellulitis extending more than 2cm or lymphangitic streaking, or spread beneath the superficial fascia or deep tissue abscess or gangrene in the opinion of the Investigator 3. Infection in patient with systemic toxicity or metabolic instability 4. Subjects showing inflammatory response of the skin caused by trauma, gout, acute charcot neuro-osteo arthropathy, fracture, thrombosis or venous stasis 5. Hemoglobin less than 8 gram per deciliter 6. White Blood Cells less than 2000 per microliter 7. Albumin less than 2.5 gram per deciliter 8. e-GFR less than 30 ml per min per 1.73m2 of body surface area 9. Subject has ulcers caused by a disease other than diabetes, for example fungal ulcerations, malignant ulcerations, and ulcerations due to venous or arterial insufficiency, or due to hematological disorders, in the opinion of the Investigator 10.Presence of any existing clinically significant medical conditions that, in the opinion of the Investigator, could interfere with wound healing 11. Patient diagnosed with HIV or cancer undergoing chemotherapy or using immunosuppressant drugs except inhalers for respiratory disorders and colchicine 12. Subjects who have received therapy for the treatment of diabetic foot in last 2 weeks 13. Subject with intolerance to beta blockers at any time in the past 14. Patients on another investigational agent or device or therapy or participated in a clinical trial within the last 4 weeks prior to enrollment 15. Pregnant or lactating women or women of childbearing potential not practicing contraception 16. Has any other factor which may, in the opinion of the Investigator, compromise participation or follow up in the Study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess safety and tolerability of Esmolol Hydrochloride gel in diabetic foot ulcer subjectsTimepoint: Baseline to End of Study | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess efficacy of Esmolol Hydrochloride gel in diabetic foot ulcer subjects in terms of proportion of subjects achieving Target Ulcer closure within 12 week treatment period and assess the time to Target Ulcer closure within 12 week treatment period Timepoint: Baseline to week 12 | — |
Countries
India
Contacts
Public ContactNitin Chandurkar
Ipca Laboratories Limited
Outcome results
None listed