Clinical Investigation of Galnobax® for the Treatment of Diabetic Foot Ulcers
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Novalead Pharma Private Limited.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
Novalead Pharma Private Limited
ClinicalTrials.gov Identifier:
NCT01113515
First Posted: April 30, 2010
Last Update Posted: April 15, 2015
Information provided by (Responsible Party):
Novalead Pharma Private Limited
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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 Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, 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) ]Incidence of adverse events (AEs) till end of follow-up phase
Secondary Outcome Measures:
- Efficacy outcome [ Time Frame: Till end of treatment (Week 12) ]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 ]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
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| Ages Eligible for Study: | 18 Years to 95 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
| Responsible Party: | Novalead Pharma Private Limited |
| ClinicalTrials.gov Identifier: | NCT01113515 History of Changes |
| Other Study ID Numbers: |
Novalead-Galnobax-0210 |
| First Submitted: | April 28, 2010 |
| First Posted: | April 30, 2010 |
| Last Update Posted: | April 15, 2015 |
| Last Verified: | April 2015 |
Keywords provided by Novalead Pharma Private Limited:
|
Diabetic foot ulcer Diabetic wound chronic non healing ulcer |
Additional relevant MeSH terms:
|
Ulcer Diabetic Foot Foot Ulcer Pathologic Processes Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Leg Ulcer Skin Ulcer Skin Diseases Diabetes Complications Diabetes Mellitus |
Endocrine System Diseases Diabetic Neuropathies Foot Diseases Esmolol Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |