A Phase III clinical trial will soon be conducted in Villa Clara to evaluate the efficacy and safety of Dermofural® 0.15% ointment as an antibacterial agent in adult patients with mild diabetic foot ulcer infection.
Diabetes mellitus (DM) is a growing and universal health problem due to the diversity and severity of its associated complications, which often lead to premature death.
According to the most recent edition of the Health Statistical Yearbook, in 2022, Cuba recorded a prevalence of 69.3 diabetics per thousand inhabitants, and in Villa Clara the figure was 63.8. In 2023, DM remained the eighth leading cause of death, with 2,281 deaths in the country and 153 in the province.
In addition to blindness, kidney failure, heart attacks, and strokes, another complication of this chronic disease is diabetic foot ulcers, which are associated with neurological, vascular, and infectious disorders and are the most common cause of lower limb amputations.
Research estimates that a patient with DM has a 25% to 35% lifetime risk of developing diabetic foot ulcers. Dr. Cecilio González Benavides, a second-degree specialist in Angiology and Vascular Surgery and general coordinator of the Comprehensive Diabetic Foot Ulcer Care Program in Villa Clara, added that 40% of these lesions can remain open for six months, another 40% for more than a year, and 10% for up to five years.
He also highlighted the benefits of applying the Cuban recombinant human epidermal growth factor (Heberprot-P®) on ulcer healing, reducing the risk of amputation, and improving patients’ quality of life.
Information published on the official website of the Center for Genetic Engineering and Biotechnology (CIGB) shows that 84% of the lesions treated with the Cuban drug were covered by granulation tissue, 46% healed completely, and amputation was avoided in 71% of cases. However, to achieve this healing, it is essential that the ulcer be free of infection.
To the delight of Cuban public health in general and Villa Clara’s science in particular, a Phase III clinical trial will soon be conducted to evaluate the efficacy and safety of Dermofural® 0.15% ointment as an antibacterial agent in adult patients with mild diabetic foot ulcer infection. A drug with a Villa Clara seal
Dermofural® 0.15% ointment is a Cuban medicine whose active pharmaceutical ingredient (furvine) is synthesized at the Center for Chemical Bioactives (CBQ) of the Marta Abreu Central University of Las Villas (UCLV), and its final formulation is produced at the Roberto Escudero Pharmaceutical Laboratory Company, located in Havana.
According to Master of Science Yenni González Lugo, head of the CBQ clinical trials and registries group and of the territorial project for the management and supervision of the Phase III clinical trial for the use of Dermofural® for diabetic foot ulcers, this ointment was registered in the country in 2007 and remained on the Basic List of Medicines from 2008 to 2016 for the external treatment of dermatophyte (fungal) lesions.
Although it is registered as an antifungal, González Lugo stated that CBQ researchers and collaborators from other national and international centers have obtained experimental evidence of furvine’s antibacterial action.
To corroborate this in medical practice, a Phase II clinical trial was conducted in 2016 with satisfactory results after applying the ointment to 37 patients with a mild bacterial infection associated with diabetic foot ulcers. Continuing the research into a third phase will involve more subjects and clinical sites and will strengthen its rigor to demonstrate the drug’s efficacy and safety as an antibacterial. This will allow it to be reinstated in the basic formulary, but with a dual action (against fungi and bacteria).
Among other advantages of the product, the researcher highlighted its broad spectrum of in vitro antibacterial activity, the low resistance-inducing capacity demonstrated so far, and its high conversion capacity; meaning that small quantities of furvine can be used to obtain large quantities of Dermofural®.
Regarding technological sovereignty and other strengths, Dr. C. María Isabel Díaz Molina, director of the CBQ, highlights the center’s ability to obtain furvine synthetically, using a technology unique in the country; the substitution of imports thanks to the use of national raw materials and production in a Cuban company; the validity of the pharmaceutical operations license and the Dermofural sanitary registration until 2027 and 2030, respectively; the alliance with Roberto Escudero, which strengthens the production chain, and the willingness of CBQ workers to guarantee a sustained supply of the active pharmaceutical ingredient for the ointment.
“We don’t work solely focused on economic results, but also on social well-being. The goal is to make the medication available to Cuban pharmacies, within the reach of patients who need it,” added Díaz Molina.
For the Phase III clinical trial to evaluate the efficacy and effectiveness of Dermofural® 0.15% ointment as an antibacterial in adult patients with mild diabetic foot ulcer infection, the contribution of a project of the same name, part of the Territorial Human Health Program, is essential. The project is managed by the University of Medical Sciences of Villa Clara and funded by the provincial delegation of the Ministry of Science, Technology, and Environment. Dr. C. Olga Lidia Véliz Concepción, head of the program, stated that the project, approved in 2022, supports the use of a nationally manufactured drug for the treatment of a condition that affects the quality of life of a large number of patients and contributes to the professional development of the researchers involved.
For his part, Master of Science Orestes González Capdevila, secretary of the regional program, recognized the seriousness with which the professionals from the CBQ and the National Clinical Trials Coordinating Center (Cencec) have worked on the protocol, which has already been approved by the Center for State Control of Medicines, Equipment, and Medical Devices (Cecmed).
“The organization has been working with Dermofural for many years, and we are convinced of the satisfactory results that this clinical trial, which is now a reality, will yield,” he stated. María Isabel Díaz Molina also highlighted the support of the Santa Clara government, based on a local project for the development, production, and marketing of furvine-based products. This has provided access to resources and financing to resolve a series of non-conformities detected by the Cecmed (Central Pharmaceutical Institute), in order to comply with the good pharmaceutical practices required by Cuban regulations.
The CBQ director added that, through a national project with BioCubaFarma, the center will continue studies on the use of furvine to obtain new finished forms for topical use, which is the subject of doctoral research by several young people from the Villa Clara state.
Clinical Trial Step by Step
Researchers, physicians, nurses, podiatrists, biostatisticians, and pharmacists are part of the multidisciplinary team conducting the Phase III placebo-controlled, randomized, double-blind clinical trial to evaluate the efficacy and safety of Dermofural® 0.15% ointment as an antibacterial agent in patients with mild diabetic foot ulcer infections.
In an interview with Vanguardia, Pedro Pablo Guerra Chaviano, Master of Science graduate and head of the Clinical Trials Department at Cencec, emphasized that this is an important step in the development of a product that has been studied for many years and will allow for simple widespread application in primary health care.
“It is being conducted in accordance with national and international standards for research involving human subjects, based on compliance with good clinical practices. It has been designed in the shortest possible time and has the ethical mission of ensuring the safety of all participating subjects.” “I believe the trial should be enrolling patients by April. It’s a recruitment process that must be carried out in all health areas of Santa Clara, and it’s up to the province to adapt the logistical conditions,” he noted.
Among the trial’s most significant features, Guerra Chaviano highlighted the participation of several clinical sites: the Arnaldo Milián Castro Clinical and Surgical Hospital and the polyclinics corresponding to the six health areas of the provincial capital (Capitán Roberto Fleites, Marta Abreu, José Ramón León Acosta, XX Aniversario, Santa Clara, and Chiqui Gómez), which requires greater ties between primary and secondary care professionals.
From adult diabetic patients of either sex, residing in Cuba, with an ulcer with a mild infection caused by various microbial agents, who attend an angiology consultation at the participating clinical sites and meet the established inclusion criteria, 164 subjects will be selected. The sample will be divided into two groups of 82 people each, each of whom will receive Dermofural® 0.15% ointment and placebo, respectively. Neither patients nor healthcare personnel will be aware of the dose being administered.
The response will be considered satisfactory if, 48 hours after completing treatment, the lesion is clinically deemed free of infection, and the presence of microorganisms is ruled out by a microbiological study.
Like all the professionals involved in the upcoming study in Villa Clara, Dr. Cecilio González Benavides places great importance on confirming the efficacy and safety of Dermofural® for this new use.
“We would be ensuring a dual role: treating less complex ulcers with a novel product, and preventing amputations, severe sepsis, and other diabetic complications that can lead to the loss of a patient’s life.
“From an economic standpoint, it represents an essential achievement. Antimicrobial creams and ointments are in short supply and expensive to import. This domestically produced, Villa Clara-based medication, with proven antifungal action, can benefit the Cuban population and also become an exportable product. “We don’t have anything similar,” he concluded.
Source: www.vanguardia.cu
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