New Inexpensive Gel for Foot Ulcers Brings “Amazing” Results

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New Inexpensive Gel for Foot Ulcers Brings “Amazing” Results

An inexpensive gel derived from a medication originally designed to treat rapid pulse rate has been shown to be both safe and effective in the treatment of diabetic foot ulcers, according to findings recently presented at the annual meeting of the European Association for the Study of Diabetes (EASD).

It’s called esmolol hydrochloride gel. It’s marketed under the trade name Galnobax and is a product of NovaLead Pharma Inc., which is a Massachusetts-based subsidiary of NovaLead Pharma Private Limited in India. The U.S. Food and Drug Administration (FDA) has approved esmolol, a beta blocker, in the United States, but only as a medication for rapid pulse and hypertension. Using it for something else is one of those instances in which a drug intended for one purpose is unexpectedly found to be effective for another. According to session presenter Ashu Rastogi, MD, of the Postgraduate Institute of Medical Education and Research in Chandigarh, India, “Esmolol can be given topically as a 14% gel and is a novel treatment option in diabetic foot ulcer.”

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The research Dr. Rastogi presented at the EASD meeting was the result of a phase 3 randomized, double-blind placebo-controlled study conducted at 27 sites in India. The study was inspired by earlier small tests in which esmolol had looked promising for foot ulcers. The subjects had an average age of 56, a body-mass index (BMI) of 25 to 26 (very slightly into the overweight range), and an average A1C (a measure of long-term glucose control) of 8.4% to 8.7%, which is in the diabetes range. Around 70% of the subjects were men.

The participants had been dealing with foot ulcers for an average duration of 40 to 50 weeks. After screening and withdrawals (39 subjects), the researchers initiated a 12-week treatment phase with participants randomly assigned to one of three groups: esmolol (14% gel) along with standard of care administered twice daily (57 subjects); standard of care only (63 subjects); or a placebo (inactive) gel administered twice a day along with standard of care (17 subjects). Standard of care, which was given to all participants, consisted of removal of damaged tissue (debridement), wound cleaning, maintenance of a moist wound environment, fresh bandages twice a day, and, if necessary, off-loading footwear (therapeutic shoes designed to provide pressure redistribution for people at risk for diabetic foot conditions ). The study lasted 24 weeks: first a 12-week treatment period and then a 12-week observation period.

Esmolol gel linked to improved foot ulcer outcomes

After the 12-week treatment period, the percentage of participants with complete ulcer closure was 60.3% in the esmolol plus standard of care group. For the standard of care-only group the percentage was 41.7%. After 24 weeks, the percentage of subjects with complete ulcer closure was 77.2% (esmolol) versus 55.6% (standard of care). Time to ulcer closure was about the same in the esmolol and standard of care groups — 74.3 vs 72.5 days.

The researchers also analyzed results based on ulcer location. For example, ulcers on the soles of the feet (plantar-based ulcers) had 58.7% complete closure with esmolol compared to 43.1% for standard of care, and for non-plantar ulcers, complete closure was found in 63.6% (esmolol) versus 38.1% (standard of care). Esmolol was similarly more successful in both large and small ulcers and it was better in people with higher BMIs and A1C numbers.

In an interview with the medical website Medscape, session attendee Ketan Dhatariya, MD, commented, “This is an amazing study. I’m part of a working group looking at the updating of a guideline for the International Working Group of the Diabetic Foot, reviewing all the studies on wound healing, specifically pharmacological interventions. This is way beyond anything shown to date in terms of medical intervention. [The authors] should be congratulated; this is really astounding. Right now, there is very little out there in terms of pharmacological interventions that have shown benefit. Once this study has been peer-reviewed and is published properly, it is potentially game-changing because it is a generic, worldwide, cheap, and freely available medication.”

Want to learn more about foot ulcers? Read “Diabetic Foot Ulcers: What They Are and How You Can Avoid Them?”

Joseph Gustaitis

Joseph Gustaitis

Joseph Gustaitis on social media

A freelance writer and editor based in the Chicago area, Gustaitis has a degree in journalism from Columbia University. He has decades of experience writing about diabetes and related health conditions and interviewing healthcare experts.

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