Phase 3
Completed N=176
Phase 3 Study to Evaluate the Safety and Efficacy of Galnobax® in Treating Diabetic Foot Ulcers
Source: ClinicalTrials.gov NCT03998436 ↗Enrolled (actual)
176
Serious AEs
4.0%
Results posted
Sep 2023
Primary outcomePrimary: Proportion of Subjects Achieving Target Ulcer Closure Within 12-week Treatment Phase, as Assessed by Blinded Investigator — 41; 30; 10 Participants — p=0.0276
◆ Published Evidence
Established
23citations · ~8 / year
Topical Esmolol Hydrochloride as a Novel Treatment Modality for Diabetic Foot Ulcers: A Phase 3 Randomized Clinical 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). 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.
Linked Publications
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Topical Esmolol Hydrochloride as a Novel Treatment Modality for Diabetic Foot Ulcers: A Phase 3 Randomized Clinical Trial.
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 |
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) and the linked publication. 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. Informational only — not medical advice.