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NCT Number: NCT01113515

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

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.

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Key information

Conditions

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

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

S.L. Raheja Hospital, Mumbai, Maharashtra, India

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esmolol hydrochloride

Drug

Other names: Galnobax-14%

Placebo Gel

Drug

Other names: Placebo control

Primary outcomes

  1. Safety Outcome

    Time frame: Till end of follow up period (Week 25)

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

Secondary outcomes

  1. Efficacy Outcome

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

    To evaluate the percent change in ulcer area and ulcer volume from baseline till end of treatment (Week 12) in different groups

  2. Efficacy Outcome

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

    Time in days taken for closure of wound in different groups from baseline till end of treatment (week 12 or 84 +/- 2 days)

Other outcomes

  1. Pharmacokinetic Measurements

    Time frame: 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).

    Pharmacokinetic profile of Galnobax® in subset of patients suffering from DFU

Sponsors and collaborators

Lead sponsor

Novalead Pharma Private Limited

Industry

Registry information

Official study 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)

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 30, 2010
Registry last updated
May 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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