Diabetic Foot Ulcer – Symptoms, Complications, and Causes

A successful regulatory professional, Robert Gadimian draws on two decades of experience working in the pharmaceutical industry. Over the years, Robert Gadimian is involved in creating drug combinations to treat diabetic foot ulcers.

With a prevalence of 15 percent among diabetic patients, a diabetic foot ulcer is an open wound or sore that often develops around the foot’s bottom. At the initial stage, a diabetic foot ulcer can present with drainage from the foot (which makes socks wet), swelling, and sometimes redness. Diabetic foot ulcers result in infection and several other ulcer-related complications after some time, which may require hospitalization. In severe cases, patients are amputated as an intervention for complication progress. If the disease is detected early, chances of healing with treatment are possible, which will minimize the risk of infection.

A diabetic foot ulcer can occur in any diabetic patient. African Americans, Hispanics, Native Americans, and seniors, however, have higher risk factors. Likewise, diabetic patients undergoing insulin medication and patients with a diabetes-induced eye, kidney, or heart disease may develop the condition. Tobacco, alcohol, and obesity are some other risk factors. If a diabetic patient has a vascular disease, the chances of suffering complications from diabetic foot ulcers increase due to slower healing, including infection.

Generally, multiple factors can play an important role in the development of diabetic foot ulcers. Examples are foot deformities, poor circulation, irritation, duration of diabetes, and trauma. Diabetic foot ulcer patients slowly lose sensation in their foot which may cause subjecting of the foot to constant friction or pressure (2 causes of inflammation) without realizing. The inability to feel pain results from the disease’s neuropathy, which a podiatrist can assess using a painless instrument called a monofilament.

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FDA Investigates Possible Infections

A recipient of an MS in pharmacy from Uppsala University, Robert Gadimian draws on 20 years of experience working in large pharmaceutical and small biotechnology companies. The president of Perceptive Regulatory Consulting firm in California, Robert Gadimian engages with several drug industry clients, including the European Medicines Agency (EMA) of the European Union and the U.S. Food and Drug Administration (FDA).

On April 01, 2021, the U.S. Food and Drug Administration announced an active investigation based on numerous medical device reports that describe possible contamination issues linked with reprocessed urological endoscopes, including ureteroscopes, cystoscopes, and cystourethroscopy. The aforementioned devices are utilized by healthcare professionals in the assessment of patients' urinary tracts. Three recent reports have announced mortality associated with these infections outside of the United States, which necessitates action to help communicate educated information to health care providers and the general public.

The current reprocessing method for medical devices, like urological endoscopes, employs high-level disinfection or sterilization, in addition to cleaning, which had made these reprocessed devices considered safe by experts until the recent issue. However, some reports suggest that these infections' potential causes could be poor device maintenance or inadequate reprocessing. FDA is currently evaluating every known possibility, such as device design and reprocessing instruction in labels. Although the risk of infection has been low based on data so far, the FDA aims to pay serious attention to all reports of such adverse events and encourages prompt reporting of such cases to the administration to identify and understand possible risks more effectively. 

The Role of Regulatory CMC in Pharmaceutical Development

Burbank, California, resident and independent regulatory consultant Robert Gadimian has extensive experience in the drug approval process. As part of his work, Robert Gadimian has familiarity with regulations related to Chemistry, Manufacturing, and Controls (CMC).

The role of regulatory CMC has become so important that the field is expanding to become its own sector. Called CMC Regulatory Affairs (RA), the field is an important part of drug and product development along the entire cycle of development, licensing, manufacture, and marketing. CMC RA is a governance process that guarantees drug development and manufacturing adhere to regulatory guidelines established by governing agencies such as the Food and Drug Administration.

The activities involved with CMC RA are twofold: manufacturing and quality control testing of the product. Other activities that occur include defining specifications and stability of the product, defining the place where the product is manufactured, and specifying the tools used to support the location where products are manufactured (i.e., facility design, operation, maintenance, and qualification).

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Rophe Pharma’s Cost-Effective Diabetic Foot Ulcer Treatment

An established pharmaceutical development leader, Robert Gadimian guides Perceptive Regulatory Consulting and provides client-tailored pathways toward meeting global compliance mandates. Robert Gadimian additionally helms Rophe Pharma, which has a number of innovative, patent pending products under development.

Among these is the diabetic foot ulcer treatment RPHE-3917, which combines a pair of already FDA approved products within a topical formulation. To date, only three diabetic foot ulcer treatments have been FDA approved. One is derived from cultured cells of the neonatal foreskin, while another comes from neonatal dermal fibroblasts. Both of these formulations have the drawback of being prohibitively expensive.

By contrast, RPHE-3917 is designed for ease of use and cost-effectiveness, with experimental data indicating consistently positive results. Generating a breadth of data on this formulation will enable intellectual property rights to be obtained. In addition, Rophe Pharma is working toward a patentable topical formulation for treatment of diabetic foot ulcer.

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