Phase 3 Study to Evaluate the Safety and Efficacy of Galnobax® in Treating Diabetic Foot Ulcers

NCT03998436 | Completed Phase 3 Results FDA Drug

• 1 other identifier: NG-A16
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of the current Study is to determine the safety and effectiveness of Galnobax® plus Standard of Care versus only Standard of Care, in treating Diabetic Foot Ulcers (DFU). In addition, Study is designed to investigate the safety of Galnobax® vehicle for establishing non-deleterious effects of Vehicle on wound healing in the Subjects with DFU. The study is being conducted in 350 subjects being recruited in about 30 centers in India.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects Achieving Target Ulcer Closure Within 12-week Treatment Phase, as Assessed by Blinded Investigator

  Proportion of complete closure of wounds within 12-week treatment phase where Complete wound closure is defined as complete skin re-epithelialization that is without drainage or dressing requirements evaluated in two visits two weeks apart from first observation of closure.

  Wound closure assessed up to week 12 and confirmed by 2 visits 2 weeks apart; only participants with wound closure at or before Week 12 and who maintained closure after 4-weeks of follow-up reported

Secondary Outcomes (1)

• Proportion of Subjects Achieving Target Ulcer Closure Till End of Study, as Assessed by the Blinded Investigator.

  24-weeks. The ulcers achieving complete closure till end of study

Other Outcomes (1)

• Proportion of Subjects With Treatment Emergent Adverse Events (TEAEs)

  24-weeks

Study Arms (3)

Galnobax® 14% gel plus SoC

ACTIVE COMPARATOR

Galnobax 14% gel along with Standard of Care (SoC) will be administered twice daily (150 subjects)

Drug: Esmolol Hydrochloride

SoC Only

SHAM COMPARATOR

Only Standard of Care will be administered twice daily (150 subjects)

Other: Only Standard of Care

Vehicle plus SoC

PLACEBO COMPARATOR

Vehicle gel along with Standard of Care (SoC) will be administered twice daily (50 subjects)

Other: Vehicle Gel

Interventions

Esmolol Hydrochloride DRUG

Galnobax-14% gel application along with Standard of Care

Also known as: Galnobax

Galnobax® 14% gel plus SoC

Only Standard of Care OTHER

Only Standard of Care treatment

SoC Only

Vehicle Gel OTHER

Vehicle gel application along with Standard of Care

Vehicle plus SoC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects, male or female, aged 18 to 75 years (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control
• Subject has glycosylated hemoglobin, HbA1C, ≤ 12%
• Subject with diagnosis of neuropathic foot ulcer by 10g monofilament test
• Subject has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.3
• Presence of at least one DFU that meets all of the following criteria:
• A full-thickness ulcer of Grade A1 as per Texas classification system;
• Ulcer is located below or up to 5 cm above the malleoli (excluding ulcers between the toes);
• Ulcer size (area) is ≥ 2 cm2 and ≤ 15 cm2 (post-debridement);
• There is a minimum 3 cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot, post-debridement;
• No exposed bone, tendon, muscle, ligament or joint capsule, and no tunneling, undermining, or sinus tracts;
• Unresponsive to ulcer care and open for at least 6 weeks at the time of the Screening Visit;
• Ulcer is non-infected as determined by clinical assessment and complete hemogram;
• Ulcer has a clean, granulating base free of adherent slough to the greatest extent possible as per Investigator;
• Ulcer area reduction \< 30% from the Screening Visit to Baseline visit
• Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Investigator

You may not qualify if:

• Actively infected ulcers with or without purulent discharge, ulcers with exposed bone or associated with osteomyelitis
• Subjects with more than three ulcers below knee
• Subjects with Target Ulcer requiring off-loading that cannot be effectively off-loaded; or unable to tolerate the off-loading method
• Subject has ulcers caused by a disease other than diabetes, e.g., fungal ulcerations, malignant ulcerations, and ulcerations due to venous or arterial insufficiency, or due to hematological disorders, in the opinion of the Investigator
• Ulcer, about which the Investigator is suspicious for cancer
• Subjects with a gangrenous or ischemic ulcer
• Subject with ulcer that in the opinion of the Investigator, may need amputation
• Subject with Target ulcer where wound measurement is not possible, such as ulcers between toes
• Body mass index (BMI) \> 40 kg/m2
• Laboratory values at Screening of:
• Hemoglobin \< 10.0 g/dL
• White Blood Cells (WBC) \< 2.0 X 109 cells/L
• Liver function studies \[Total bilirubin, aspartate aminotransferase (AST) and alanine transaminase (ALT)\] \> 3x the upper limit of normal
• Albumin \< 2.5 g/dL
• eGFR \< 25 mL/min

Sponsors & Collaborators

• Novalead Pharma Private Limited: lead

Study Sites (14)

Yalamanchi Hospita

Vijayawada, Andhra Pradesh, 520002, India

Location

M.S. Ramaiah Medical College and Hospital

Bangalore, Karnataka, 560054, India

Location

Sapthagiri Institute of Medical Sciences and Research Centre

Bangalore, Karnataka, 560090, India

Location

Rajlaxmi Hospital

Bangalore, Karnataka, 560097, India

Location

Sri Siddhartha Medical College

Tumkūr, Karnataka, 572107, India

Location

Sujata Birla Hospital & Medical Research Center

Nashik, Maharashtra, 422101, India

Location

Deenanath Mangeshkar Hospital and Research Center

Pune, Maharashtra, 411004, India

Location

Chellaram Diabetes Institute

Pune, Maharashtra, 411021, India

Location

Appollo Hospital

Chennai, Tamil Nadu, 600006, India

Location

M.V. Hospital for Diabetes Pvt Ltd

Chennai, Tamil Nadu, 600013, India

Location

Madras Diabetes Research Foundation

Chennai, Tamil Nadu, 600086, India

Location

Sri Ramachandra Hospital

Chennai, Tamil Nadu, 600116, India

Location

Post Graduate Institute of Medical Education and Research (PGIMER)

Chandigarh, 110012, India

Location

Maharaja Agrasen Hospital

New Delhi, 110026, India

Location

Related Publications (1)

• Rastogi A, Kulkarni SA, Agarwal S, Akhtar M, Arsule S, Bhamre S, Bhosle D, Desai S, Deshmukh M, Giriraja KV, Jagannath J, Kashiva RY, Kesavan R, Khandelwal D, Kolte S, Kongara S, Darivemula AK, Madhusudan C, Pyare Saheb Qureshi MAH, Ramu M, Rathod G, Yalamanchi SR, Shakya S, Shetty P, Singh S, Deshpande SK, Viswanathan V, Unnikrishnan AG. Topical Esmolol Hydrochloride as a Novel Treatment Modality for Diabetic Foot Ulcers: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2311509. doi: 10.1001/jamanetworkopen.2023.11509.

  PMID: 37184839 DERIVED

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 K. Deshpande
• Organization: Novalead Pharma Pvt. Ltd.

supreet@novaleadpharma.com

7066233033

Study Officials

• Ashu Rastogi, MD

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The subject will be masked from the treatment by the Study Nurse (care giver) by using blinder during each treatment application. The site has two separate teams (blinded and unblinded) for masking. The unblinded investigator performs application of treatment during each treatment visit of subject to the site.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, Multicenter, Randomized, Double-Blind, Parallel groups

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 26, 2019
• Study Start: December 26, 2018
• Primary Completion: August 19, 2021
• Study Completion: December 6, 2021
• Last Updated: September 22, 2023
• Results First Posted: September 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (14)