Diabetic Foot UlcerPhase 1/2NCT01113515
Clinical Investigation of Galnobax® for the Treatment of Diabetic Foot Ulcers
A Phase 1/2 study testing Esmolol hydrochloride in people with Diabetic Foot Ulcer, run by Novalead Pharma Private Limited at 5 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 95 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
- 44 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 20 Feb 2014to 17 Oct 2015
- Phase
- Phase 1/2
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
India3 sites
M V Hospital for Diabetes Pvt. Ltd.
Chennai, Tamil Nadu, 600 013
S.L. Raheja Hospital
Mumbai, Maharashtra, 400016
Deenanath Mangeshkar Hospital & Research Center
Pune, Maharashtra, 411004
United States1 site
VA New England Health Care Division
Providence, Rhode Island, 02908
About this study
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)
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.
Read the 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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Esmolol hydrochloride, Placebo gel
- Keywords
- Diabetic foot ulcer, Diabetic wound, chronic non healing ulcer
- 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-14%
Esmolol hydrochlorideDrug
Also called Galnobax-20%
Esmolol hydrochlorideDrug
Also called Galnobax-QD
Placebo gelDrug
Also called Placebo control
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo gel Receives: Drug: Placebo gel |
| Galnobax 20% QD | Experimental | Esmolol Hydrochloride (Galnobax) 20% gel once daily Receives: Drug: Esmolol hydrochloride |
| Galnobax 20% BID | Experimental | Esmolol Hydrochloride (Galnobax) 20% gel twice daily Receives: Drug: Esmolol hydrochloride |
| Galnobax 14% BID | Experimental | Esmolol Hydrochloride (Galnobax) 14% gel twice daily Receives: Drug: Esmolol hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Outcome
Number of participant with adverse events (AEs) till end of follow-up phase in different groups
Measured: Till end of follow up period (Week 25)
Secondary outcomes (2)
Efficacy Outcome
To evaluate the percent change in ulcer area and ulcer volume from baseline till end of treatment (Week 12) in different groups
Measured: Baseline and end of treatment (Week 12 or 84 +/- 2 days)
Efficacy Outcome
Time in days taken for closure of wound in different groups from baseline till end of treatment (week 12 or 84 +/- 2 days)
Measured: From baseline till end of treatment (Week 12 or 84 +/- 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
- Study start20 Feb 2014
- Primary completion27 Jun 2015
- Study completion17 Oct 2015
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novalead Pharma Private Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vickie R Driver, DPM FACFAS, Principal investigator, Providence Veteran Affairs Medical Center, RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113515
- Sponsor's protocol ID
- Novalead-Galnobax-0210
- Status last verified
- May 2024
- First submitted
- 28 Apr 2010
- Last updated
- 20 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 36245145
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01113515
- Acronym / sponsor ID
- Novalead-Galnobax-0210
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetic foot ulcer, Diabetic wound, chronic non healing ulcer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Novalead Pharma Private LimitedIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2014 (actual)
- Primary completion
- 27 Jun 2015 (actual)
- Study completion
- 17 Oct 2015 (actual)
- First posted
- 30 Apr 2010 (estimated)
- Results
- Posted 20 May 2024
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo gelPlacebo gel |
| Galnobax 20% QD | Experimental | Drug: Esmolol hydrochlorideEsmolol Hydrochloride (Galnobax) 20% gel once daily |
| Galnobax 20% BID | Experimental | Drug: Esmolol hydrochlorideEsmolol Hydrochloride (Galnobax) 20% gel twice daily |
| Galnobax 14% BID | Experimental | Drug: Esmolol hydrochlorideEsmolol Hydrochloride (Galnobax) 14% gel twice daily |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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: Galnobax-14% | Drug | Galnobax 14% BID |
| Esmolol hydrochlorideAlso: Galnobax-20% | Drug | Galnobax 20% BID |
| Esmolol hydrochlorideAlso: Galnobax-QD | Drug | Galnobax 20% QD |
| Placebo gelAlso: Placebo control | Drug | Placebo |
Primary outcome
Safety Outcome
Time frame: Till end of follow up period (Week 25)
Number of participant with adverse events (AEs) till end of follow-up phase in different groups
2 secondary outcomes
Efficacy Outcome
Time frame: Baseline and end of treatment (Week 12 or 84 +/- 2 days)
Efficacy Outcome
Time frame: From baseline till end of treatment (Week 12 or 84 +/- 2 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36245145Rastogi 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.
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
Vickie R Driver, DPM FACFAS principal investigator
Providence Veteran Affairs Medical Center, RI
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Esmolol hydrochloride in people with Diabetic Foot Ulcer, run by Novalead Pharma Private Limited at 5 sites in 3 countries.
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 8 inclusion and 9 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 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India, United States, Malaysia. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 20 May 2024). 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?
Safety Outcome (time frame: Till end of follow up period (Week 25)). 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 NCT01113515, 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 20 May 2024.