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India’s diabetologists note that foot infections are a cause for concern. This is because they account for substantial morbidity and lead to lower limb amputations. Currently, diabetic foot infections (DFI) affect 15% of diabetics in India manifesting Pseudomonas, E. coli, and S. aureus infections. Considering the criticality of DFI, the recent US FDA norms related to this critical condition are viewed as timely by the Indian pharma and healthcare sectors.
In its recent guidance titled ‘Diabetic Foot Infections: Developing Drugs for Treatment’, the US FDA focused on clinical trial protocols, and stated that many diabetic patients sustain repeated, localized foot trauma. There is a huge need for the clinical development of drugs to treat DFIs without injuries to connected bone and joint involvement.
From an India perspective, the Diabetic Food Society of India has a registry protocol to create a comprehensive nationwide database for analysis of outcomes from diabetic foot surgery in the country. The data will provide the improving the range of surgical information available, which in turn helps assess and raise the standard of patient care continually. It will promote research projects too.
According to Dr Amey Pednekar, consultant, plastic and cosmetic surgery, Manipal Hospital, one of the biggest unrecognized problems in the healthcare scenario is non-healing wounds. From the discomfort of having an active wound to the pain and the financial burden of treatment, the suffering is endless. Diabetic patients with non-healing wounds comprise a major proportion of these cases.
In its efforts to provide a guidance for drug development, US FDA said that the treatment is multifactorial, requiring debridement of devitalized tissue, drainage of any abscesses, reperfusion in cases of critical limb ischemia, removing pressure on the infected wound, optimizing glycemic control, administration of appropriate antibacterial therapy, and application of dressings that allow for moist wound healing besides control of excess exudation.
US FDA stated that its guidance is for the industry for developing antibacterial drugs for DFI. These are monomicrobial or polymicrobial.
The intent is to acute bacterial skin and skin structure infections medicines to address early phase drug development, classify the population, focus on safety and support the effectiveness of the investigational drug, said US FDA.
Noting that management of diabetic foot involves multidisciplinary approach, Dr Mani Deepthi Dasari, endocrinologist, Apollo Hospitals, said this covers wound assessment, surgical removal of dead necrotic tissue, dressing and use of antibiotics based on the organism.
Here hyperbaric oxygen therapy is done to promote healing. Wound off-loading and assessment of blood flow is assessed via an ultrasound scan. Glycemic control with insulin and regular monitoring of blood glucose values are important, added Dr Mani Deepthi Dasari.
Diabetic peripheral neuropathy combined with vascular insufficiency in the lower limbs is the main reason for DFI. Any treatment protocol needs to incorporate early detection of impending risks with routine blood checks, arterial doppler of the lower limbs, and neurological evaluation of the feet. For patients with ulcers, the aim is to control the infection source early with IV antibiotics. Self-awareness and rehabilitation also are a part of the treatment protocol, stated Dr. Gauri Shankar Akula, consultant, reconstructive and aesthetic surgery, Kauvery Hospital.
Hence, the recent US FDA norms for drug development in the context of diabetic foot infections have been timely, according to diabetologists.
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