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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Diabetic Foot Ulcer	Drug: Esmolol hydrochloride; Drug: Placebo gel	Phase 1; Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	50 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	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)
Study Start Date :	February 2014
Estimated Primary Completion Date :	September 2015
Estimated Study Completion Date :	December 2015

Arms and Interventions

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Arm	Intervention/treatment
Placebo Comparator: Placebo; Placebo gel	Drug: Placebo gel; Other Name: Placebo control
Experimental: Galnobax 20% QD; Esmolol Hydrochloride (Galnobax) 20% gel once daily	Drug: Esmolol hydrochloride; Other Name: Galnobax-QD
Experimental: Galnobax 20% BID; Esmolol Hydrochloride (Galnobax) 20% gel twice daily	Drug: Esmolol hydrochloride; Other Name: Galnobax-20%
Experimental: Galnobax 14% BID; Esmolol Hydrochloride (Galnobax) 14% gel twice daily	Drug: Esmolol hydrochloride; Other Name: Galnobax-14%

Outcome Measures

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Primary Outcome Measures :

1. Safety outcome [ Time Frame: Till end of follow up period (Week 25) ]
   Incidence of adverse events (AEs) till end of follow-up phase

Secondary Outcome Measures :

1. Efficacy outcome [ Time Frame: Till end of treatment (Week 12) ]
   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

Other Outcome Measures:

1. Pharmacokinetics [ Time Frame: Till end of treatment ]
   Pharmacokinetic profile of Galnobax® in subset of patients suffering from DFU

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 95 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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 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

Contacts and Locations

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Locations

United States, Rhode Island
VA New England Health Care Division
Providence, Rhode Island, United States, 02908
India
S.L. Raheja Hospital
Mumbai, Maharashtra, India, 400016
Deenanath Mangeshkar Hospital & Research Center
Pune, Maharashtra, India, 411004
M V Hospital for Diabetes Pvt. Ltd.
Chennai, Tamil Nadu, India, 600 013
Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia

Sponsors and Collaborators

Novalead Pharma Private Limited

Investigators

Principal Investigator:	Vickie R Driver, DPM FACFAS	Providence Veteran Affairs Medical Center, RI

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Novalead Pharma Private Limited
ClinicalTrials.gov Identifier:	NCT01113515 History of Changes
Other Study ID Numbers:	Novalead-Galnobax-0210
First Posted:	April 30, 2010
Last Update Posted:	April 15, 2015
Last Verified:	April 2015

Keywords provided by Novalead Pharma Private Limited:

Diabetic foot ulcer; Diabetic wound; chronic non healing ulcer

Additional relevant MeSH terms:

Ulcer; Diabetic Foot; Foot Ulcer; Pathologic Processes; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Diabetes Complications; Diabetes Mellitus	Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases; Esmolol; Adrenergic beta-1 Receptor Antagonists; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs