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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novalead Pharma Private Limited
ClinicalTrials.gov Identifier:
NCT01113515
First received: April 28, 2010
Last updated: April 14, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Diabetic Foot Ulcer
Drug: Esmolol hydrochloride
Drug: Placebo gel
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Novalead Pharma Private Limited:

Primary Outcome Measures:
  • Safety outcome [ Time Frame: Till end of follow up period (Week 25) ] [ Designated as safety issue: Yes ]
    Incidence of adverse events (AEs) till end of follow-up phase


Secondary Outcome Measures:
  • Efficacy outcome [ Time Frame: Till end of treatment (Week 12) ] [ Designated as safety issue: No ]
    To evaluate the change from baseline in area and volume of ulcers at Week 12 and to compare the time taken for healing and closure of wound in different groups from baseline


Other Outcome Measures:
  • Pharmacokinetics [ Time Frame: Till end of treatment ] [ Designated as safety issue: Yes ]
    Pharmacokinetic profile of Galnobax® in subset of patients suffering from DFU


Estimated Enrollment: 50
Study Start Date: February 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo gel
Drug: Placebo gel
Other Name: Placebo control
Experimental: Galnobax 20% QD
Esmolol Hydrochloride (Galnobax) 20% gel once daily
Drug: Esmolol hydrochloride
Other Name: Galnobax-QD
Experimental: Galnobax 20% BID
Esmolol Hydrochloride (Galnobax) 20% gel twice daily
Drug: Esmolol hydrochloride
Other Name: Galnobax-20%
Experimental: Galnobax 14% BID
Esmolol Hydrochloride (Galnobax) 14% gel twice daily
Drug: Esmolol hydrochloride
Other Name: Galnobax-14%

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01113515

Locations
United States, Rhode Island
VA New England Health Care Division
Providence, Rhode Island, United States, 02908
India
S.L. Raheja Hospital
Mumbai, Maharashtra, India, 400016
Deenanath Mangeshkar Hospital & Research Center
Pune, Maharashtra, India, 411004
M V Hospital for Diabetes Pvt. Ltd.
Chennai, Tamil Nadu, India, 600 013
Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia
Sponsors and Collaborators
Novalead Pharma Private Limited
Investigators
Principal Investigator: Vickie R Driver, DPM FACFAS Providence Veteran Affairs Medical Center, RI
  More Information

No publications provided

Responsible Party: Novalead Pharma Private Limited
ClinicalTrials.gov Identifier: NCT01113515     History of Changes
Other Study ID Numbers: Novalead-Galnobax-0210
Study First Received: April 28, 2010
Last Updated: April 14, 2015
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India
Malaysia: Ministry of Health

Keywords provided by Novalead Pharma Private Limited:
Diabetic foot ulcer
Diabetic wound
chronic non healing ulcer

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Ulcer
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Diabetic Neuropathies
Endocrine System Diseases
Foot Diseases
Leg Ulcer
Pathologic Processes
Skin Diseases
Skin Ulcer
Vascular Diseases
Esmolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 03, 2015