Clinical trial NCT01113515: Clinical Investigation of Galnobax® for the Treatment of Diabetic Foot Ulcers
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetic Foot Ulcer
Keywords: Diabetic foot ulcer
Diabetic wound
chronic non healing ulcer
Lead sponsor: Novalead Pharma Private Limited
Sponsor class: INDUSTRY
First posted: 2010-04-30
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Safety Outcome
timeFrame: Till end of follow up period (Week 25)
Secondary outcomes:
measure: Efficacy Outcome
timeFrame: Baseline and end of treatment (Week 12 or 84 +/- 2 days)
measure: Efficacy Outcome
timeFrame: From baseline till end of treatment (Week 12 or 84 +/- 2 days)
Other outcomes:
measure: Pharmacokinetic Measurements
timeFrame: 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).
Locations:
city: Providence
country: United States
facility: VA New England Health Care Division
state: Rhode Island
city: Mumbai
country: India
facility: S.L. Raheja Hospital
state: Maharashtra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital & Research Center
state: Maharashtra
city: Chennai
country: India
facility: M V Hospital for Diabetes Pvt. Ltd.
state: Tamil Nadu
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
Study officials:
affiliation: Providence Veteran Affairs Medical Center, RI
name: Vickie R Driver, DPM FACFAS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rastogi A, Kulkarni SA, Deshpande SK, Driver V, Barman H, Bal A, Deshmukh M, Nair H. Novel Topical Esmolol Hydrochloride (Galnobax) for Diabetic Foot Wound: Phase 1/2, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Parallel-Group Study. Adv Wound Care (New Rochelle). 2023 Aug;12(8):429-439. doi: 10.1089/wound.2022.0093. Epub 2022 Nov 16.