4 risultati
Study Procedures:
Collection of Demographic data, medical/social history Collection of medications1 Ankle Brachial Index2 Wound debridement3 (standard of care procedure) Imaging with eKare4 Hyperspectral Imaging Application of study product
1. Only collect antibiotics, anti-fungal and anti-infective
A simple standardization of the clinical examination (Foot Risk Grading), history collection and biological data will be organized by the study sponsors.
List of collected data, origin and circuit of the data:
Entry of patient data (clinical, biological and additional examinations) on a database
Infection: will be defined as a patient with three of six clinical signs of infection (erythema, heat, edema, pain, loss of function, purulence) or leukocytosis. We will use the Infectious Diseases Society of America's Diabetic Foot Infection guidelines to stratify the severity of infection. This
This pilot study will be the first time that nicotine will be applied directly onto the surface of chronic diabetic ulcer. The goals of the study are to evaluate safety and tolerability (particularly at the wound site) of a gel formulation containing low-dose nicotine, and to obtain preliminary