Diabetic foot ulcer is a principal diabetic complication. It has been shown that diabetic patients have decreased growth factor concentrations in their tissues, particularly epidermal growth factor. Growth factor shortage impairs wound healing, which leads to chronic nonhealing wounds and sometimes eventual amputation. Ischemic diabetic foot ulcer is the most difficult to treat and confers the highest amputation risk. Injecting epidermal growth factor deep into the wound bottom and contours encourages a more effective pharmacodynamic response in terms of granulation tissue growth and wound closure. Epidermal growth factor injected into the ulcer matrix may also result in association with extracellular matrix proteins, thus enhancing cell proliferation and migration. Heberprot-P is an innovative Cuban product containing recombinant human epidermal growth factor for peri- and intra-lesional infiltration; evidence reveals it accelerates healing of deep and complex ulcers, both ischemic and neuropathic, and reduces diabetes-related amputations. Clinical trials of Heberprot-P in patients with diabetic foot ulcers have shown that repeated local infiltration of this product can enhance healing of chronic wounds safely and efficaciously. As a result, Heberprot-P was registered in Cuba in 2006, and in 2007 was included in the National Basic Medications List and approved for marketing. It has been registered in 15 other countries, enabling treatment of more than 100,000 patients. Heberprot-P is a unique therapy for the most complicated and recalcitrant chronic wounds usually associated with high amputation risk. Local injection in complex diabetic wounds has demonstrated a favorable risk-benefit ratio by speeding healing, reducing recurrences and attenuating amputation risk. Further testing and deployment worldwide of Heberprot-P would provide an opportunity to assess the product's potential to address an important unmet medical need.

Experiences in the nationwide program for the integral care of the patient with diabetic foot ulcer using Heberprot-P. The Cuban product Heberprot-P is indicated for the treatment of complex diabetic foot ulcers (DFU). After its registration in 2006, the product was included into the Cuban List of Medicines and a nationwide program for the integral care of the DFU patient began. To date Heberprot-P is available in more than 85 Cuban health institutions and more than 3 800 diabetic patients with ulcers in their feet have received the benefits of this unique product. An integral program has been established for the attention of the patient with DFU, including the advanced technology of Heberprot-P. This program relies on the closely linked and coordinated interaction between the primary and secondary levels of health, in which prevention and therapy merge each other. The Ministry of Public Health of Cuba has established impact indicators in order to control and assess the performance of the program.

El novedoso producto cubano Heberprot-P está indicado para el tratamiento de las úlceras complicadas del pie diabético (UPD). Una vez aprobado su registro sanitario, pasó a formar parte del Cuadro Básico de Medicamentos de Cuba, y se inició el proceso de extensión nacional. Más de 3800 pacientes diabéticos con úlceras en sus pies en Cuba han recibido las bondades de este medicamento, que se administra en más de 85 instituciones de salud del país. Se ha establecido un Programa de atención integral al paciente con úlcera del pie diabético que incluye el uso del Heberprot-P. Este programa está organizado sobre la base del trabajo coordinado del nivel primario y secundario de salud, en el que se funden el papel preventivo y terapéutico de la atención al paciente diabético. El Ministerio e Salud Pública cubano ha establecido indicadores de impacto para medir y controlar el desarrollo de este programa.

A model was introduced within the Program of Integral Attention to the Diabetic Patient (PIADP), in each policlinic of the Playa municipality in Havana, Cuba, and implemented under the integral treatment of patients with less complicated diabetic foot ulcers (DFU) and by using Heberprot-P to accelerate wound granulation and healing in an ambulatory manner. Since January of 2010, a strategy was developed in the primary health attention (PHA) of that municipality, constituted by three stages and including organizational elements such as: the elaboration of a Situational Room of the municipality, the qualification theoretical-practice of the human resources, the logistic securing, the redispensarization of diabetic patients, the programmed investigation in consultations and domiciliary visits; as well as elements of implementation: action of communitary promotion and mass media use. The application of the Heberprot-P started with the characterization of patient with DFU in the municipality and the selection of the human resources that would execute the treatment. All the 33 health professionals were prepared at each area, in the PIADP room, a system of filter for a suitable classification of the DFU was implemented. To date, 233 patients were treated, 28 of them (12.1%) requiring treatment with Heberprot-P, and their data being registered in pharmacovigilance models; 65 (27.8%) were sent to the secondary level of health, with complicated DFU and other vascular affections (60.1%). All except two of those patients, who completed treatment at the hospital, completed treatment at the PHA. The feasibility of the model by using Heberprot-P was demonstrated and an integral approach was established under intensive pharmacovigilance.

Dentro del Programa de atención integral al paciente diabético (PAID) de cada policlínico del municipio Playa de Ciudad de La Habana, Cuba, se estableció un modelo para el tratamiento integral a pacientes con úlceras de pie diabético (UPD) menos complicadas, que incorpora el uso del Heberprot-P para favorecer la granulación y curación de las lesiones en menor tiempo y de forma ambulatoria. Desde enero de 2010 se desarrolla una estrategia en la atención primaria de salud (APS) del municipio de Playa, en tres etapas que incluyen elementos organizativos, como la elaboración de una Sala situacional del municipio la capacitación teórico-práctica de los recursos humanos, el aseguramiento logístico, la redispensarización de pacientes diabéticos, la pesquisa en consultas y las visitas domiciliarias programadas; así como elementos de implementación: acciones de promoción comunitaria y uso de medios de comunicación. La aplicación del Heberprot-P partió de la caracterización de las úlceras de los pacientes diabéticos del municipio y la selección de los recursos humanos que ejecutarían el tratamiento. Se prepararon los 33 (100%) profesionales de la salud. En la consulta del PAID de cada área de salud se implementó un sistema de filtro para una adecuada clasificación de las UPD hasta la fecha. Se han atendido 233 pacientes, 28 (12.1%) que requieren tratamiento con Heberprot-P, cuyos datos se registraron en modelos de farmacovigilancia, 65 (27.8%) se remitieron al nivel secundario de salud, con UPD complicadas y otras afecciones angiológicas (60.1%). Salvo dos de estos pacientes que completaron el tratamiento en el hospital, los demás se atendieron en la APS. Se demostró la factibilidad del modelo con el uso del Heberprot-P, con un enfoque integral bajo farmacovigilancia intensiva.