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US FDA issues draft guidance on drugs for diabetic foot infections as India & and the world battle its complications

Nandita Vijayasimha, BengaluruMonday, November 20, 2023, 08:00 Hrs  [IST]

The US FDA has issued draft guidance on drugs for diabetic foot infections to assist sponsors in the clinical development of drugs. India and the rest of the world are encountering the challenge of late detection of diabetic foot ulcers. While there is a limited stockpile of medications to treat this condition, researchers are engaged in discovery of new treatment options to curb the spread.

Pharma companies and the healthcare providers are of the view that investment in research for better diabetes management strategies, new treatment options, and innovative technologies are much-needed.

In this regard, the US FDA has stated in its guidance that assessing the efficacy of antibacterial drugs to treat diabetic foot infections, the sponsor should consider providing phase 1 data demonstrating adequate drug penetration into the outer skin layers. The sponsors should discuss with the global regulator on the technique to evaluate drug penetration before study initiation.

Complication of diabetes can lead to hospitalization and, in some cases, amputation. The recent findings by the ICMR indicates an alarming rise in diabetes, affecting 101 million people, with another 136 million on the brink as pre-diabetics. Another report stated 25% develop diabetic foot ulcers, of which 50% become infected, requiring hospitalization while 20% need amputation.

To address the diabetes epidemic and its complications, it is crucial to focus on preventive measures, early detection, and effective management. Providing education on foot care for individuals with diabetes is crucial in preventing diabetic foot ulcers, pointed out medical experts.

US FDA too has seen the imperative need for new medications and in its draft guidance has insisted that drug development population should include subjects with diabetes mellitus who have a bacterial infection of the foot. Although diabetic foot infection studies may include subjects with disease ranging from deep wounds, extent of the lesion and systemic signs, the study population should consist of subjects with comparable disease extent

Medical experts across Apollo, Fortis among other medical centres categorically stated that early detection of diabetes and its complications is essential. Regular health check-ups, especially for individuals at risk, can aid in identifying diabetes at an early stage.

Addressing the diabetes challenge in India and the rest of the world requires a comprehensive and multi-faceted approach involving healthcare professionals, policymakers, communities, and individuals. By combining efforts in prevention, education, and access to quality healthcare, there is potential to reduce the burden of diabetes and its complications, including diabetic foot ulcers, noted medical experts.

In its draft guidance, US FDA mandates two adequate and well-controlled trials are needed to support the effectiveness of the investigational drug. A single adequate and well-controlled trial supported by other independent confirmatory evidence, like a related infectious disease indication which is an acute bacterial skin and its structure infections, can potentially provide evidence of effectiveness for the treatment of diabetic foot infection. For this the global regulator said, “Sponsors should discuss with us about the confirmatory evidence that could support findings from a single trial in diabetic foot infection”.

 
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