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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Drug: Placebo gel; Drug: Esmolol hydrochloride

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 93 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics	Pharmacokinetic profile of Galnobax® in subset of patients suffering from DFU	Till end of treatment

Collaborators and Investigators

• Sponsor: Novalead Pharma Private Limited
• Investigators: Principal Investigator: Vickie R Driver, DPM FACFAS, Providence Veteran Affairs Medical Center, RI

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: April 28, 2010
• First Submitted That Met QC Criteria: April 28, 2010
• First Posted (Estimate): April 30, 2010

Study Record Updates

• Last Update Posted (Estimate): April 15, 2015
• Last Update Submitted That Met QC Criteria: April 14, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Diabetic foot ulcer; Diabetic wound; chronic non healing ulcer
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic beta-1 Receptor Antagonists; Esmolol
• Other Study ID Numbers: Novalead-Galnobax-0210