Relaxation intervention to improve diabetic foot ulcer healing: Results from a pilot randomized controlled study

This pilot randomised controlled study (RCT) aimed to assess the feasibility and acceptability of a progressive muscle relaxation with guided imagery intervention (experimental group [EG]) compared to a neutral guided imagery placebo (active control group [ACG]) and standard care to diabetic foot ulcer [DFU] treatment (passive control group [PCG]), to decide on the need for a definitive RCT. Diabetic foot patients with one or two chronic DFU and significant levels of stress/anxiety/depression were recruited and assessed during a period of 6 months, at three moments. Primary outcomes: feasibility rates and satisfaction with relaxation sessions. Secondary outcomes: DFU healing score, DFU-related quality of life (DFUQoL), physical and mental HRQoL, stress and emotional distress, DFU representations, arterial blood pressure, and heart rate. A total of 146 patients completed the baseline (T0) assessment with 54 participants presenting significant distress being randomised into three groups. Patients were assessed 2 months post-intervention (T1) and 4 months after T1 (T2). Feasibility rates showed reduced values on eligibility, recruitment and inclusion in the study, although with an acceptable rate of refusal lower than 10%. On average, participants reported being satisfied with relaxation sessions and recommended them to other patients. Differences between groups showed that, at T1, PCG participants reported higher levels of stress than those from EG and ACG. Within-group differences showed improvements in stress, distress, DFUQoL and DFU extent over time only in EG and ACG. Only EG showed significant changes in DFU representations at T1. The results suggest that relaxation may be a promising coping strategy to deal with DFU distress and an important adjuvant therapy for DFU healing, supporting the implementation of a definitive RCT.