Ensaio clínico de fase II da ação cicatizante cutânea de fração proteolítica do látex de Vasconcellea Cundinamarcensis em úlceras em pés de pacientes portadores de diabetes

Abstract

Neuropathic ulcers or diabetic foot ulcers are defined by the World Health Organization (WHO) as soft tissue infections and destruction, occurring concomitantly with neurological disorders of varying degrees due to peripheral arterial disease (PAD) located in lower members. The study aimed to evaluate the healing capacity of a topical formulation containing the proteolytic fraction (P1G10) of latex of Vasconcellea cundinamarcensis, when administered in neuropathic ulcers of diabetic patients. It is a double-masked, randomized, controlled, clinical trial. The population of this study was composed of adults (age 18 years) of both sexes, users of a referral service in the treatment of wounds in the city of Belo Horizonte - Minas Gerais. The application of a thin layer of the formulation over the wound bed, covering all its extension, was performed in each patient, totalizing 48 applications. The wounds were evaluated by means of measures of their dimensions: length, width, depth and area. The effect of the intervention was estimated by the cumulative incidence of healing (up to 80 and 100% of the wound) using the Kaplan-Meier method. Statistical techniques were performed with the help of the Stata program. The study population consisted of 50 individuals. The incidence rate of total healing in subjects treated with the proteolytic fraction P1G10 was 5.15 / 1000 person-days (95% CI = 2.85-9.3). Patients who underwent P1G10 treatment had an incidence rate of 2.95 (95% CI: 1.0257-8.51) greater than that of the group treated with Hydrogel. The results contribute to increase the potential of therapeutic indications of proteolytic enzymes of Vasconcelles Cundinamarcensis. We suggest the continuity of the phase III clinical trial with a multicenter study with a larger number of participants for its use in the this pathology.