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An Indian gel to heal diabetic foot ulcers?
PGIMER, Chandigarh tests its efficacy in a new study. ‘Esmolol has a beneficial effect in reducing oxidative stress that may improve wound healing. The findings indicate that topical esmolol may be an appropriate addition to standard care protocols for treating diabetic foot ulcers,’ says Dr Ashu Rastogi, Associate Professor, Department of Endocrinology and lead author of the study
Even with the best of therapy, only 30 percent of wounds associated with diabetes heal despite several advanced treatment modalities. (Representative image/Freepik)
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An Indian gel to heal diabetic foot ulcers?
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Can a new foot gel, that’s awaiting a rollout, work on diabetic foot ulcers? A study by the Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, has found that an esmolol hydrochloride gel was far more effective than standard therapy protocols in use till now.
Sixty per cent of patients had wound closure within 12 weeks with esmolol compared to only 41 per cent with existing care routines, suggesting 2.1 times increase in chances of wound closure with esmolol. Overall, more than three-fourths of patients had complete wound healing with esmolol compared to only half with existing treatments. More importantly, esmolol led to wound healing in a certain group of patients with low haemoglobin, renal problems and low albumin, all of which slow down recovery.
“Esmolol is a short-acting beta-adrenergic receptor blocker approved by the US Food and Drug Administration. Beta blockers are traditionally used in cardiology and specifically esmolol, which has a very short duration of action, is used as an intravenous drug in tachycardia (diseases where heart rate is fast) in cardiac ICUs. But we found some prior literature that esmolol has a beneficial effect in reducing oxidative stress that may improve wound healing. We first repurposed esmolol for topical application and studied how it can be made in various gel concentrations. The findings indicate that topical esmolol may be an appropriate addition to the care protocol for treating diabetic foot ulcers. This can change the way we treat diabetic foot wounds. Esmolol gel can become the standard of care for physicians taking care of diabetic patients with foot ulcers. The drug has been patented by Dr Sudhir Kulkarni, the co-investigator, and will soon be marketed after regulatory approvals. It shall be included very soon in the guidelines for the management of foot ulcers,” says Dr Ashu Rastogi, Associate Professor, Department of Endocrinology and lead author of the study, “Topical Esmolol Hydrochloride as a Novel Treatment Modality for Diabetic Foot Ulcers: A Phase 3 Randomised Clinical Trial.”
The results of the study were presented by Dr Rastogi at the European Diabetes Congress at Stockholm, Sweden, in September 2022 and were very much applauded. The final results of the study have been published recently in the prestigious peer-reviewed journal JAMA Network Open.
Diabetic Foot Ulcers (DFUs), says Dr Rastogi, are common but not discussed as much as a severe complication of diabetes. The prevalence of DFUs is between 1.3 and 12 per cent in various countries. Indians rarely take up issues pertaining to DFU seriously because of socio-cultural beliefs, delayed health-seeking behaviour and out-of-pocket expenditure. “Around one in five patients with diabetes is likely to develop foot ulcers. Foot complications, including DFUs, substantially contribute to diabetes-related mortality because of infections and stubborn wounds that require amputation. In a large study, spanning several centres across the country, we found that a person with DFU is three times more likely to die earlier (mainly because of cardiac issues) than a routine diabetic person without ulcer. Also, mortality due to foot ulcers is higher than certain cancers,” explains Dr Rastogi.
Even with the best of therapy, only 30 per cent of wounds associated with diabetes heal despite several advanced treatment modalities. These include advanced moist wound therapy, bioengineered tissue or skin substitutes, peptides, growth factors, electric stimulation and negative pressure wound therapy. Also, the ulcer recurrence rate is 40 to 70 per cent. “The main goal is prevention of foot ulcers through routine screening and regular checkups. However, after formation of ulcer, complete wound healing is the primary outcome measure. Additionally, many of these patients harbour other complications, including cardiac, renal and infectious issues which need comprehensive management,” he says.
As for challenges faced in routine management of diabetic foot disease and associated ulcers, Dr Rastogi explains that in India, around 70 per cent of the population lives in rural areas but 80 per cent of the doctors provide services in urban areas. Thus, the rural population has minimal access to good healthcare services. Foot self-care education and examination are essential for preventing foot complications, but a lack of trained podiatrist staff in India causes an increased prevalence of diabetes foot-related complications.
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Elaborating on the premise of the study, Dr Rastogi says that even with the best standards of care, only one in three diabetic foot wounds heals and hence there is a need for research and innovation to develop newer treatment options. “We conducted the first proof of concept study in-vitro in rats and guinea pigs to demonstrate how esmolol can improve migration of certain cells and growth factors around the wound to hasten ulcer healing. We also demonstrated that esmolol improves collagen content that is required for wound closure and showed its safety. Subsequently, we performed the first human study in the world with topical esmolol and demonstrated its safety at 14 per cent gel concentration.”
First published on: 15-06-2023 at 17:40 IST
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