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

NCT01113515 | Completed Phase 1 Results

• 1 other identifier: Novalead-Galnobax-0210
• Study Type: interventional
• Target: 44
• Locations: 3 countries
• Sites: 5

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.

Conditions

Diabetic Foot Ulcer

Keywords

Diabetic foot ulcer; Diabetic wound; chronic non healing ulcer

Outcome Measures

Primary Outcomes (1)

• Safety Outcome

  Number of participant with adverse events (AEs) till end of follow-up phase in different groups

  Till end of follow up period (Week 25)

Secondary Outcomes (2)

• Efficacy Outcome

  Baseline and end of treatment (Week 12 or 84 +/- 2 days)

• Efficacy Outcome

  From baseline till end of treatment (Week 12 or 84 +/- 2 days)

Other Outcomes (1)

• Pharmacokinetic Measurements

  pre-dose (prior to first study drug application), and at 15 and 30 minutes, 1, 3, 6, 12, and 24 hours after the first study drug application on day 0, weeks 1, 4, and 12 (prior to study drug application).

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo gel

Drug: Placebo gel

Galnobax 20% QD

EXPERIMENTAL

Esmolol Hydrochloride (Galnobax) 20% gel once daily

Drug: Esmolol hydrochloride

Galnobax 20% BID

EXPERIMENTAL

Esmolol Hydrochloride (Galnobax) 20% gel twice daily

Drug: Esmolol hydrochloride

Galnobax 14% BID

EXPERIMENTAL

Esmolol Hydrochloride (Galnobax) 14% gel twice daily

Drug: Esmolol hydrochloride

Interventions

Esmolol hydrochloride DRUG

Also known as: Galnobax-14%

Galnobax 14% BID

Placebo gel DRUG

Also known as: Placebo control

Placebo

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Novalead Pharma Private Limited: lead

Study Sites (5)

VA New England Health Care Division

Providence, Rhode Island, 02908, United States

Location

S.L. Raheja Hospital

Mumbai, Maharashtra, 400016, India

Location

Deenanath Mangeshkar Hospital & Research Center

Pune, Maharashtra, 411004, India

Location

M V Hospital for Diabetes Pvt. Ltd.

Chennai, Tamil Nadu, 600 013, India

Location

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia

Location

Related Publications (1)

• Rastogi A, Kulkarni SA, Deshpande SK, Driver V, Barman H, Bal A, Deshmukh M, Nair H. Novel Topical Esmolol Hydrochloride (Galnobax) for Diabetic Foot Wound: Phase 1/2, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Parallel-Group Study. Adv Wound Care (New Rochelle). 2023 Aug;12(8):429-439. doi: 10.1089/wound.2022.0093. Epub 2022 Nov 16.

  PMID: 36245145 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Interventions

esmolol

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: Supreet Deshpande
• Organization: NovaLead Pharma Pvt. Ltd.

supreet@novaleadpharma.com

+91-866-965-6660

Study Officials

• Vickie R Driver, DPM FACFAS

  Providence Veteran Affairs Medical Center, RI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2010
• First Posted: April 30, 2010
• Study Start: February 20, 2014
• Primary Completion: June 27, 2015
• Study Completion: October 17, 2015
• Last Updated: May 20, 2024
• Results First Posted: May 20, 2024

Record last verified: 2024-05

Locations

MY (1); US (1); IN (3)