Diabetic Foot UlcerPhase 3NCT03998436
Phase 3 Study to Evaluate the Safety and Efficacy of Galnobax® in Treating Diabetic Foot Ulcers
A Phase 3 study testing Esmolol Hydrochloride in people with Diabetic Foot Ulcer, run by Novalead Pharma Private Limited at 14 sites in India.
Trial summary
The purpose of the current Study is to determine the safety and effectiveness of Galnobax® plus Standard of Care versus only Standard of Care, in treating Diabetic Foot Ulcers (DFU). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Esmolol Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 14 sitesIndia
- Study dates
- 26 Dec 2018to 6 Dec 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects, male or female, aged 18 to 75 years (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control
- Subject has glycosylated hemoglobin, HbA1C, ≤ 12%
- Subject with diagnosis of neuropathic foot ulcer by 10g monofilament test
- Subject has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.3
- Presence of at least one DFU that meets all of the following criteria:
- A full-thickness ulcer of Grade A1 as per Texas classification system;
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- Ulcer is located below or up to 5 cm above the malleoli (excluding ulcers between the toes);
- Ulcer size (area) is ≥ 2 cm2 and ≤ 15 cm2 (post-debridement);
- There is a minimum 3 cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot, post-debridement;
- No exposed bone, tendon, muscle, ligament or joint capsule, and no tunneling, undermining, or sinus tracts;
- Unresponsive to ulcer care and open for at least 6 weeks at the time of the Screening Visit;
- Ulcer is non-infected as determined by clinical assessment and complete hemogram;
- Ulcer has a clean, granulating base free of adherent slough to the greatest extent possible as per Investigator;
- Ulcer area reduction < 30% from the Screening Visit to Baseline visit
- Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Investigator
- Subject, if female of child-bearing potential, has a negative urine pregnancy test at Screening and willing to use acceptable methods of contraception (birth control pills, barriers) or abstinence throughout the Study
- Subject is able and willing to comply with Study procedures including the use of an off-loading device (as applicable for the location of the ulcer) and adhere to protocol during the Study in the opinion of Investigator
- A Subject or LAR agrees to sign informed consent form and allow audio visual recording of consent, if applicable
Who cannot join
- Actively infected ulcers with or without purulent discharge, ulcers with exposed bone or associated with osteomyelitis
- Subjects with more than three ulcers below knee
- Subjects with Target Ulcer requiring off-loading that cannot be effectively off-loaded; or unable to tolerate the off-loading method
- Subject has ulcers caused by a disease other than diabetes, e.g., fungal ulcerations, malignant ulcerations, and ulcerations due to venous or arterial insufficiency, or due to hematological disorders, in the opinion of the Investigator
- Ulcer, about which the Investigator is suspicious for cancer
- Subjects with a gangrenous or ischemic ulcer
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- Subject with ulcer that in the opinion of the Investigator, may need amputation
- Subject with Target ulcer where wound measurement is not possible, such as ulcers between toes
- Body mass index (BMI) > 40 kg/m2
- Laboratory values at Screening of:
- Hemoglobin < 10.0 g/dL
- White Blood Cells (WBC) < 2.0 X 109 cells/L
- Liver function studies [Total bilirubin, aspartate aminotransferase (AST) and alanine transaminase (ALT)] > 3x the upper limit of normal
- Albumin < 2.5 g/dL
- eGFR < 25 mL/min
- Presence of any existing clinically significant medical condition(s) that, in the opinion of the Investigator, could interfere with wound healing
- Subject has received or is currently receiving or scheduled to receive any medication or therapies during the course of the Study that will modulate wound healing
- Subject with intolerance to β-blockers at any time in the past
- Has any other factor which may, in the opinion of the Investigator, compromise participation and/or follow-up in the Study
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
India14 sites
M.S. Ramaiah Medical College and Hospital
Bangalore, Karnataka, 560054
Sapthagiri Institute of Medical Sciences and Research Centre
Bangalore, Karnataka, 560090
Rajlaxmi Hospital
Bangalore, Karnataka, 560097
Post Graduate Institute of Medical Education and Research (PGIMER)
Chandigarh, 110012
Appollo Hospital
Chennai, Tamil Nadu, 600006
M.V. Hospital for Diabetes Pvt Ltd
Chennai, Tamil Nadu, 600013
Madras Diabetes Research Foundation
Chennai, Tamil Nadu, 600086
Sri Ramachandra Hospital
Chennai, Tamil Nadu, 600116
Sujata Birla Hospital & Medical Research Center
Nashik, Maharashtra, 422101
Maharaja Agrasen Hospital
New Delhi, 110026
Deenanath Mangeshkar Hospital and Research Center
Pune, Maharashtra, 411004
Chellaram Diabetes Institute
Pune, Maharashtra, 411021
Sri Siddhartha Medical College
Tumkūr, Karnataka, 572107
Yalamanchi Hospita
Vijayawada, Andhra Pradesh, 520002
About this study
Official title: A Prospective, Multicenter, Randomized, Double-Blind, Phase 3 Study to Evaluate the Safety and Efficacy of a Gel Formulation of Esmolol Hydrochloride (Galnobax®) in Treating Diabetic Foot Ulcers
The purpose of the current Study is to determine the safety and effectiveness of Galnobax® plus Standard of Care versus only Standard of Care, in treating Diabetic Foot Ulcers (DFU). In addition, Study is designed to investigate the safety of Galnobax® vehicle for establishing non-deleterious effects of Vehicle on wound healing in the Subjects with DFU. The study is being conducted in 350 subjects being recruited in about 30 centers in India.
Read the detailed description
The current study is a Prospective, Multicenter, Randomized, Double-Blind, Phase 3 Study to Evaluate the Safety and Efficacy of a Gel Formulation of Esmolol Hydrochloride (Galnobax®) in Treating Diabetic Foot Ulcers. The study evaluates the safety and effectiveness of Galnobax® plus Standard of Care versus only Standard of Care, in treating Diabetic Foot Ulcers (DFU). In addition, Study is designed to investigate the safety of Galnobax® vehicle for establishing non-deleterious effects of Vehicle on wound healing in the Subjects with DFU.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Esmolol Hydrochloride, Only Standard of Care, Vehicle Gel
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esmolol HydrochlorideDrug
Also called Galnobax
Galnobax-14% gel application along with Standard of Care
Only Standard of CareOther
Only Standard of Care treatment
Vehicle GelOther
Vehicle gel application along with Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Galnobax® 14% gel plus SoC | Active comparator | Galnobax 14% gel along with Standard of Care (SoC) will be administered twice daily (150 subjects) Receives: Drug: Esmolol Hydrochloride |
| SoC Only | Sham comparator | Only Standard of Care will be administered twice daily (150 subjects) Receives: Other: Only Standard of Care |
| Vehicle plus SoC | Placebo comparator | Vehicle gel along with Standard of Care (SoC) will be administered twice daily (50 subjects) Receives: Other: Vehicle Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Achieving Target Ulcer Closure Within 12-week Treatment Phase, as Assessed by Blinded Investigator
Proportion of complete closure of wounds within 12-week treatment phase where Complete wound closure is defined as complete skin re-epithelialization that is without drainage or dressing requirements evaluated in two visits two weeks apart from first observation of closure.
Measured: Wound closure assessed up to week 12 and confirmed by 2 visits 2 weeks apart; only participants with wound closure at or before Week 12 and who maintained closure after 4-weeks of follow-up reported
Secondary outcomes (1)
Proportion of Subjects Achieving Target Ulcer Closure Till End of Study, as Assessed by the Blinded Investigator.
Proportion of complete closure of wounds at 24-weeks or End of Study where Complete wound closure is defined as complete skin re-epithelialization that is without drainage or dressing requirements.
Measured: 24-weeks. The ulcers achieving complete closure till end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start26 Dec 2018
- Primary completion19 Aug 2021
- Study completion6 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Multicenter, Randomized, Double-Blind, Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novalead Pharma Private Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashu Rastogi, MD, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998436
- Sponsor's protocol ID
- NG-A16
- Status last verified
- Aug 2023
- First submitted
- 24 Jun 2019
- Last updated
- 22 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rastogi A, Kulkarni SA, Agarwal S, Akhtar M, Arsule S, Bhamre S, Bhosle D, Desai S, Deshmukh M, Giriraja KV, Jagannath J, Kashiva RY, Kesavan R, Khandelwal D, Kolte S, Kongara S, Darivemula AK, Madhusudan C, Pyare Saheb Qureshi MAH, Ramu M, Rathod G, Yalamanchi SR, Shakya S, Shetty P, Singh S, Deshpande SK, Viswanathan V, Unnikrishnan AG. Topical Esmolol Hydrochloride as a Novel Treatment Modality for Diabetic Foot Ulcers: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2311509. doi: 10.1001/jamanetworkopen.2023.11509.
PubMed 37184839
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Double-Blind, Phase 3 Study to Evaluate the Safety and Efficacy of a Gel Formulation of Esmolol Hydrochloride (Galnobax®) in Treating Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT03998436
- Acronym / sponsor ID
- NG-A16
- Conditions
- Diabetic Foot Ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Novalead Pharma Private LimitedIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2018 (actual)
- Primary completion
- 19 Aug 2021 (actual)
- Study completion
- 6 Dec 2021 (actual)
- First posted
- 26 Jun 2019 (actual)
- Results
- Posted 22 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the current Study is to determine the safety and effectiveness of Galnobax® plus Standard of Care versus only Standard of Care, in treating Diabetic Foot Ulcers (DFU). In addition, Study is designed to investigate the safety of Galnobax® vehicle for establishing non-deleterious effects of Vehicle on wound healing in the Subjects with DFU. The study is being conducted in 350 subjects being recruited in about 30 centers in India.
Detailed description
The current study is a Prospective, Multicenter, Randomized, Double-Blind, Phase 3 Study to Evaluate the Safety and Efficacy of a Gel Formulation of Esmolol Hydrochloride (Galnobax®) in Treating Diabetic Foot Ulcers. The study evaluates the safety and effectiveness of Galnobax® plus Standard of Care versus only Standard of Care, in treating Diabetic Foot Ulcers (DFU). In addition, Study is designed to investigate the safety of Galnobax® vehicle for establishing non-deleterious effects of Vehicle on wound healing in the Subjects with DFU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, Multicenter, Randomized, Double-Blind, Parallel groups
| Arm | Type | Receives |
|---|---|---|
| Galnobax® 14% gel plus SoC | Active comparator | Drug: Esmolol HydrochlorideGalnobax 14% gel along with Standard of Care (SoC) will be administered twice daily (150 subjects) |
| SoC Only | Sham comparator | Other: Only Standard of CareOnly Standard of Care will be administered twice daily (150 subjects) |
| Vehicle plus SoC | Placebo comparator | Other: Vehicle GelVehicle gel along with Standard of Care (SoC) will be administered twice daily (50 subjects) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Subjects, male or female, aged 18 to 75 years (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control
- Subject has glycosylated hemoglobin, HbA1C, ≤ 12%
- Subject with diagnosis of neuropathic foot ulcer by 10g monofilament test
- Subject has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.3
- Presence of at least one DFU that meets all of the following criteria:
Key exclusion criteria (19 listed)
- Actively infected ulcers with or without purulent discharge, ulcers with exposed bone or associated with osteomyelitis
- Subjects with more than three ulcers below knee
- Subjects with Target Ulcer requiring off-loading that cannot be effectively off-loaded; or unable to tolerate the off-loading method
- Subject has ulcers caused by a disease other than diabetes, e.g., fungal ulcerations, malignant ulcerations, and ulcerations due to venous or arterial insufficiency, or due to hematological disorders, in the opinion of the Investigator
- Ulcer, about which the Investigator is suspicious for cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esmolol HydrochlorideAlso: GalnobaxGalnobax-14% gel application along with Standard of Care | Drug | Galnobax® 14% gel plus SoC |
| Only Standard of CareOnly Standard of Care treatment | Other | SoC Only |
| Vehicle GelVehicle gel application along with Standard of Care | Other | Vehicle plus SoC |
Primary outcome
Proportion of Subjects Achieving Target Ulcer Closure Within 12-week Treatment Phase, as Assessed by Blinded Investigator
Time frame: Wound closure assessed up to week 12 and confirmed by 2 visits 2 weeks apart; only participants with wound closure at or before Week 12 and who maintained closure after 4-weeks of follow-up reported
Proportion of complete closure of wounds within 12-week treatment phase where Complete wound closure is defined as complete skin re-epithelialization that is without drainage or dressing requirements evaluated in two visits two weeks apart from first observation of closure.
1 secondary outcome
Proportion of Subjects Achieving Target Ulcer Closure Till End of Study, as Assessed by the Blinded Investigator.
Time frame: 24-weeks. The ulcers achieving complete closure till end of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37184839Rastogi A, Kulkarni SA, Agarwal S, Akhtar M, Arsule S, Bhamre S, Bhosle D, Desai S, Deshmukh M, Giriraja KV, Jagannath J, Kashiva RY, Kesavan R, Khandelwal D, Kolte S, Kongara S, Darivemula AK, Madhusudan C, Pyare Saheb Qureshi MAH, Ramu M, Rathod G, Yalamanchi SR, Shakya S, Shetty P, Singh S, Deshpande SK, Viswanathan V, Unnikrishnan AG. Topical Esmolol Hydrochloride as a Novel Treatment Modality for Diabetic Foot Ulcers: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2311509. doi: 10.1001/jamanetworkopen.2023.11509.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashu Rastogi, MD principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Esmolol Hydrochloride in people with Diabetic Foot Ulcer, run by Novalead Pharma Private Limited at 14 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects Achieving Target Ulcer Closure Within 12-week Treatment Phase, as Assessed by Blinded Investigator (time frame: Wound closure assessed up to week 12 and confirmed by 2 visits 2 weeks apart; only participants with wound closure at or before Week 12 and who maintained closure after 4-weeks of follow-up reported). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03998436, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.