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

Diabetic Foot Ulcer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01113515
• Other study ID #: Novalead-Galnobax-0210
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 20, 2014
• Est. completion date: October 17, 2015

Study information

• Verified date: May 2024
• Source: Novalead Pharma Private Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 17, 2015
• Est. primary completion date: June 27, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Drug:
• Esmolol hydrochloride

• Esmolol hydrochloride

• Esmolol hydrochloride

• Placebo gel

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Novalead Pharma Private Limited

Countries where clinical trial is conducted

United States,  India,  Malaysia, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pharmacokinetic Measurements	Pharmacokinetic profile of Galnobax® in subset of patients suffering from DFU	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).
Primary	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	Efficacy Outcome	To evaluate the percent change in ulcer area and ulcer volume from baseline till end of treatment (Week 12) in different groups	Baseline and end of treatment (Week 12 or 84 +/- 2 days)
Secondary	Efficacy Outcome	Time in days taken for closure of wound in different groups from baseline till end of treatment (week 12 or 84 +/- 2 days)	From baseline till end of treatment (Week 12 or 84 +/- 2 days)