About
The diabetic foot is one of the complications of diabetes that incurs significant costs for the individual, family, and national health system. Considering that knowledge about the underlying mechanisms of the relationship between stress and chronic wound healing is very limited and nonexistent concerning diabetic foot ulcers (DFUs), as well as evidence of the efficacy of psychological interventions such as relaxation and hypnosis in reducing stress and promoting healing, this study examined the quality of life (QoL) and the healing process in patients with DFUs. Three complementary studies were developed: assessment of the contribution of psychological factors to DFU healing and patient QoL (Study 1); study of the efficacy of progressive muscle relaxation and hypnosis on psychological variables, QoL, and physiological indicators of healing prognosis (Study 2); and qualitative analysis of the efficacy of progressive muscle relaxation and hypnosis on the variables of Study 2, according to the perspective of patients and their informal caregivers (Study 3).
This study utilized a longitudinal design and included patients from the Multidisciplinary Diabetic Foot Clinic of three central hospitals in Portugal. Assessments took place at the first consultation (T0), after two months (T1), and six months later (T2). After the initial assessment (T0), patients were randomly allocated to four groups: progressive muscle relaxation intervention group with guided imagery (GE1); hypnosis intervention group with guided imagery (GE2); active control group with neutral sessions and guided imagery (GCA); and passive control group receiving standard medical/nursing intervention only (GCP).
Inclusion criteria were: > 18 years old; up to two chronic DFUs at baseline; and signed informed consent. In Study 2, only patients with clinically significant psychological distress were included. Exclusion criteria included DFUs classified as recurrences, having three or more DFUs at baseline, transplant patients, patients on hemodialysis, oncological disease, severe psychiatric illness or dementia, and patients receiving psychological treatment. Study 3 included participants from Study 2 who completed at least 75% of the intervention (GE1 and GE2), along with their informal caregiver.
This is the first national and international project to include the contribution of psychological variables and the evaluation of the efficacy of two psychological interventions, including physiological indicators of healing prognosis (inflammatory markers; biochemical parameters, angiogenic markers, and miRNAs) using a randomized longitudinal design.
