Trial | NCT01113515  Report issue

Title

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)

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    esmolol ...

  • Study Participants

    50
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.
Study Started
Feb 28
2014
Primary Completion
Sep 30
2015
Anticipated
Study Completion
Dec 31
2015
Anticipated
Last Update
Apr 15
2015
Estimate

Drug Esmolol hydrochloride

  • Other names: Galnobax-14%

Drug Esmolol hydrochloride

  • Other names: Galnobax-20%

Drug Esmolol hydrochloride

  • Other names: Galnobax-QD

Drug Placebo gel

  • Other names: Placebo control

Placebo Placebo Comparator

Placebo gel

Galnobax 20% QD Experimental

Esmolol Hydrochloride (Galnobax) 20% gel once daily

Galnobax 20% BID Experimental

Esmolol Hydrochloride (Galnobax) 20% gel twice daily

Galnobax 14% BID Experimental

Esmolol Hydrochloride (Galnobax) 14% gel twice daily

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
No Results Posted