Clinical Investigation of Galnobax® for the Treatment of Diabetic Foot Ulcers

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Interventional, Placebo-Controlled, Randomized, Double-blinded Dose Comparison, Phase I/II Study to Determine the Safety and Efficacy of a New Gel Formulation of Esmolol Hydrochloride (Galnobax®) for the Treatment of Diabetic Foot Ulcer (DFU)

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Drug: Esmolol hydrochloride
* Drug: Esmolol hydrochloride
* Drug: Esmolol hydrochloride
* Drug: Placebo gel


Participation Criteria
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Eligibility Criteria
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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 cm2 and 10 cm2, inclusive and post debridement ulcer area less than or equal to 12 cm2. Full-thickness ulcer of Grade 1 or Grade 2 as per Wagner's 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 Inability to perceive 10 grams pressure using Semmes-Weinstein 5.07 monofilament in the peri-ulcer area Ankle Brachial index between 0.7 and 1.2 Exclusion Criteria: Actively infected ulcers with or without 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) >12% 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 >3.0 mg/dL or renal insufficiency requiring frequent dialysis Poor nutritional status as measured by serum albumin <3.0 g/dL Active Charcot or other structural deformity that would prevent adequate off-loading of the study foot

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo gel | Drug: Placebo gel<br> <br> * Other names: Placebo control;|
| Experimental: Galnobax 20% QD<br>Esmolol Hydrochloride (Galnobax) 20% gel once daily | Drug: Esmolol hydrochloride<br> <br> * Other names: Galnobax-QD;|
| Experimental: Galnobax 20% BID<br>Esmolol Hydrochloride (Galnobax) 20% gel twice daily | Drug: Esmolol hydrochloride<br> <br> * Other names: Galnobax-20%;|
| Experimental: Galnobax 14% BID<br>Esmolol Hydrochloride (Galnobax) 14% gel twice daily | Drug: Esmolol hydrochloride<br> <br> * Other names: Galnobax-14%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety outcome | Incidence of adverse events (AEs) till end of follow-up phase | Till end of follow up period (Week 25) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy outcome | To evaluate the change from baseline in area and volume of ulcers at Week 12 and to compare the time taken for healing and closure of wound in different groups from baseline | Till end of treatment (Week 12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic foot ulcer, Diabetic wound, chronic non healing ulcer