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

NCT ID: NCT03998436

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-26
• Study Completion Date: 2021-12-06

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.

Detailed Description

The current study is a Prospective, Multicenter, Randomized, Double-Blind, Phase 3 Study to Evaluate the Safety and Efficacy of a Gel Formulation of Esmolol Hydrochloride (Galnobax®) in Treating Diabetic Foot Ulcers. The study evaluates 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.

Conditions

Diabetic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Galnobax® 14% gel plus SoC

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

Group Type: ACTIVE_COMPARATOR

Esmolol Hydrochloride

Intervention Type: DRUG

Galnobax-14% gel application along with Standard of Care

SoC Only

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

Group Type: SHAM_COMPARATOR

Only Standard of Care

Intervention Type: OTHER

Only Standard of Care treatment

Vehicle plus SoC

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

Group Type: PLACEBO_COMPARATOR

Vehicle Gel

Intervention Type: OTHER

Vehicle gel application along with Standard of Care

Interventions

Esmolol Hydrochloride

Galnobax-14% gel application along with Standard of Care

Intervention Type: DRUG

Only Standard of Care

Only Standard of Care treatment

Intervention Type: OTHER

Vehicle Gel

Vehicle gel application along with Standard of Care

Intervention Type: OTHER

Other Intervention Names

Galnobax

Eligibility Criteria

Inclusion Criteria

1. Subjects, male or female, aged 18 to 75 years (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control

2. Subject has glycosylated hemoglobin, HbA1C, ≤ 12%

3. Subject with diagnosis of neuropathic foot ulcer by 10g monofilament test

4. Subject has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.3

5. Presence of at least one DFU that meets all of the following criteria:

1. A full-thickness ulcer of Grade A1 as per Texas classification system;

2. Ulcer is located below or up to 5 cm above the malleoli (excluding ulcers between the toes);

3. Ulcer size (area) is ≥ 2 cm2 and ≤ 15 cm2 (post-debridement);

4. There is a minimum 3 cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot, post-debridement;

5. No exposed bone, tendon, muscle, ligament or joint capsule, and no tunneling, undermining, or sinus tracts;

6. Unresponsive to ulcer care and open for at least 6 weeks at the time of the Screening Visit;

7. Ulcer is non-infected as determined by clinical assessment and complete hemogram;

8. Ulcer has a clean, granulating base free of adherent slough to the greatest extent possible as per Investigator;

9. Ulcer area reduction < 30% from the Screening Visit to Baseline visit

6. Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Investigator

7. Subject, if female of child-bearing potential, has a negative urine pregnancy test at Screening and willing to use acceptable methods of contraception (birth control pills, barriers) or abstinence throughout the Study

8. Subject is able and willing to comply with Study procedures including the use of an off-loading device (as applicable for the location of the ulcer) and adhere to protocol during the Study in the opinion of Investigator

9. A Subject or LAR agrees to sign informed consent form and allow audio visual recording of consent, if applicable

Exclusion Criteria

1. Actively infected ulcers with or without purulent discharge, ulcers with exposed bone or associated with osteomyelitis

2. Subjects with more than three ulcers below knee

3. Subjects with Target Ulcer requiring off-loading that cannot be effectively off-loaded; or unable to tolerate the off-loading method

4. 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

5. Ulcer, about which the Investigator is suspicious for cancer

6. Subjects with a gangrenous or ischemic ulcer

7. Subject with ulcer that in the opinion of the Investigator, may need amputation

8. Subject with Target ulcer where wound measurement is not possible, such as ulcers between toes

9. Body mass index (BMI) > 40 kg/m2

10. Laboratory values at Screening of:

1. Hemoglobin < 10.0 g/dL

2. White Blood Cells (WBC) < 2.0 X 109 cells/L

3. Liver function studies [Total bilirubin, aspartate aminotransferase (AST) and alanine transaminase (ALT)] > 3x the upper limit of normal

4. Albumin < 2.5 g/dL

5. eGFR < 25 mL/min

11. Presence of any existing clinically significant medical condition(s) that, in the opinion of the Investigator, could interfere with wound healing

12. Subject has received or is currently receiving or scheduled to receive any medication or therapies during the course of the Study that will modulate wound healing

13. Subject with intolerance to β-blockers at any time in the past

14. Has any other factor which may, in the opinion of the Investigator, compromise participation and/or follow-up in the Study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novalead Pharma Private Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashu Rastogi, MD

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Locations

Yalamanchi Hospita

Vijayawada, Andhra Pradesh, India

M.S. Ramaiah Medical College and Hospital

Bangalore, Karnataka, India

Sapthagiri Institute of Medical Sciences and Research Centre

Bangalore, Karnataka, India

Rajlaxmi Hospital

Bangalore, Karnataka, India

Sri Siddhartha Medical College

Tumkūr, Karnataka, India

Sujata Birla Hospital & Medical Research Center

Nashik, Maharashtra, India

Deenanath Mangeshkar Hospital and Research Center

Pune, Maharashtra, India

Chellaram Diabetes Institute

Pune, Maharashtra, India

Appollo Hospital

Chennai, Tamil Nadu, India

M.V. Hospital for Diabetes Pvt Ltd

Chennai, Tamil Nadu, India

Madras Diabetes Research Foundation

Chennai, Tamil Nadu, India

Sri Ramachandra Hospital

Chennai, Tamil Nadu, India

Post Graduate Institute of Medical Education and Research (PGIMER)

Chandigarh, , India

Maharaja Agrasen Hospital

New Delhi, , India

Countries

India

References

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.

Reference Type: DERIVED

PMID: 37184839 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NG-A16

Identifier Type: -

Identifier Source: org_study_id