Phase 3 Study to Evaluate the Safety and Efficacy of Galnobax® in Treating Diabetic Foot Ulcers
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Intervention: Esmolol Hydrochloride; Only Standard of Care; Vehicle Gel
Intervention description: Galnobax-14% gel application along with Standard of Care; Only Standard of Care treatment; Vehicle gel application along with Standard of Care
Intervention MeSH terms: Esmolol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, Multicenter, Randomized, Double-Blind, Parallel groups
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: 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.
Enrollment: 176.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

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