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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Diabetic Foot Ulcer

In brief

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.

Key facts

Study ID

NCT01113515

Run by

Novalead Pharma Private Limited

People needed

44

Starts

2014-02-20

Expected to finish

2015-10-17

Last updated by the study team

2024-05-20

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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