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

Phase 1

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo gel	Placebo gel
Galnobax 20% QD	Esmolol hydrochloride	Esmolol Hydrochloride (Galnobax) 20% gel once daily
Galnobax 20% BID	Esmolol hydrochloride	Esmolol Hydrochloride (Galnobax) 20% gel twice daily
Galnobax 14% BID	Esmolol hydrochloride	Esmolol Hydrochloride (Galnobax) 14% gel twice daily

Primary Outcome Measures

Name	Time	Method
Safety Outcome	Till end of follow up period (Week 25)	Number of participant with adverse events (AEs) till end of follow-up phase in different groups

Secondary Outcome Measures

Name	Time	Method
Efficacy Outcome	From baseline till end of treatment (Week 12 or 84 +/- 2 days)	Time in days taken for closure of wound in different groups from baseline till end of treatment (week 12 or 84 +/- 2 days)

Locations (5): M V Hospital for Diabetes Pvt. Ltd.
🇮🇳
Chennai, Tamil Nadu, India
Hospital Kuala Lumpur
🇲🇾
Kuala Lumpur, Malaysia
S.L. Raheja Hospital
🇮🇳
Mumbai, Maharashtra, India
VA New England Health Care Division
🇺🇸
Providence, Rhode Island, United States
Deenanath Mangeshkar Hospital & Research Center
🇮🇳
Pune, Maharashtra, India