Conditions: Diabetic Foot Ulcer
Keywords: Diabetic foot ulcer Diabetic wound chronic non healing ulcer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 44
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine safety and efficacy of a new gel formulation of Esmolol hydrochloride (Galnobax®) for the treatment of Diabetic Foot Ulcer (DFU). The study will compare number and types of adverse events occured, rates of wound closure and percentage of wounds closed in Galnobax treated groups versus placebo group.

Detailed description:
This is an interventional, placebo-controlled, randomized, double-blinded, dose comparison, phase I/II study of Galnobax® in subjects with diabetic foot ulcers. Additionally the effect of dosage and frequency of application will also be studied . The total trial duration per subject is 25 weeks which comprises of 1 week for screening, 12 weeks of treatment and 12 weeks of follow-up.

Arms:
arm 1: Placebo gel arm 2: Esmolol Hydrochloride (Galnobax) 20% gel once daily arm 3: Esmolol Hydrochloride (Galnobax) 20% gel twice daily arm 4: Esmolol Hydrochloride (Galnobax) 14% gel twice daily

Interventions: intervention 1: Esmolol hydrochloride intervention 2: Esmolol hydrochloride intervention 3: Esmolol hydrochloride intervention 4: Placebo gel
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol document: