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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Novalead Pharma Private Limited
Sponsor:
Information provided by (Responsible Party):
Novalead Pharma Private Limited
ClinicalTrials.gov Identifier:
NCT01113515
First received: April 28, 2010
Last updated: May 27, 2014
Last verified: February 2014

April 28, 2010
May 27, 2014
February 2014
December 2014   (final data collection date for primary outcome measure)
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
Safety outcome [ Time Frame: Every week till end of follow up period (Week 25) ] [ Designated as safety issue: Yes ]
Incidence of adverse events (AEs) till end of follow-up phase
Complete list of historical versions of study NCT01113515 on ClinicalTrials.gov Archive Site
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
Efficacy outcome [ Time Frame: Till end of treatment (Week 13) ] [ Designated as safety issue: No ]
To evaluate the change from baseline in area of ulcers at Week 12 and to compare the time taken for healing and closure of wound in different groups from baseline
Pharmacokinetics [ Time Frame: Till end of treatment ] [ Designated as safety issue: Yes ]
Pharmacokinetic profile of Galnobax® in subset of patients suffering from DFU
Not Provided
 
Clinical Investigation of Galnobax® for the Treatment of Diabetic Foot Ulcers
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)

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Diabetic Foot Ulcer
  • Drug: Esmolol hydrochloride
    Other Name: Galnobax-14%
  • Drug: Esmolol hydrochloride
    Other Name: Galnobax-20%
  • Drug: Esmolol hydrochloride
    Other Name: Galnobax-QD
  • Drug: Placebo gel
    Other Name: Placebo control
  • Placebo Comparator: Placebo
    Placebo gel
    Intervention: Drug: Placebo gel
  • Experimental: Galnobax 20% QD
    Esmolol Hydrochloride (Galnobax) 20% gel once daily
    Intervention: Drug: Esmolol hydrochloride
  • Experimental: Galnobax 20% BID
    Esmolol Hydrochloride (Galnobax) 20% gel twice daily
    Intervention: Drug: Esmolol hydrochloride
  • Experimental: Galnobax 14% BID
    Esmolol Hydrochloride (Galnobax) 14% gel twice daily
    Intervention: Drug: Esmolol hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
April 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 95 Years
No
United States,   India,   Malaysia
 
NCT01113515
Novalead-Galnobax-0210
No
Novalead Pharma Private Limited
Novalead Pharma Private Limited
Not Provided
Principal Investigator: Vickie R Driver, DPM FACFAS Providence Veteran Affairs Medical Center, RI
Novalead Pharma Private Limited
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP