Phase 3
N=176
Phase 3 Study to Evaluate the Safety and Efficacy of Galnobax® in Treating Diabetic Foot Ulcers
Diabetic Foot Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT03998436 ↗Enrolled (actual)
176
Serious AEs
4.0%
Results posted
Sep 2023
Primary outcome: Primary: Proportion of Subjects Achieving Target Ulcer Closure Within 12-week Treatment Phase, as Assessed by Blinded Investigator — 41; 30; 10 Participants — p=0.0276
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Esmolol Hydrochloride (Drug); Only Standard of Care (Other); Vehicle Gel (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novalead Pharma Private Limited
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects Achieving Target Ulcer Closure Within 12-week Treatment Phase, as Assessed by Blinded Investigator |
41; 30; 10 | 0.0276 sig |
| SECONDARY Proportion of Subjects Achieving Target Ulcer Closure Till End of Study, as Assessed by the Blinded Investigator. |
44; 35; 9 | 0.0126 sig |
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). 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.
Eligibility Criteria
Inclusion Criteria
- 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;
- 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 40 kg/m2
- Laboratory values at Screening of:
- Hemoglobin 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
Data sourced from ClinicalTrials.gov (NCT03998436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.