Table 1.
Schedule of enrollment, interventions, and assessments of the PSY-DFU study, following the Standard Protocol Items Recommendations for Interventional Trials (SPIRIT) guidelines.
| TIMEPOINTS | Enrollment | Allocation | Pos-Allocation | Follow-Up | ||
|---|---|---|---|---|---|---|
| T0 | T0 | T1 | 2 Weeks after T1 | T2 | ||
| Eligibility | X | |||||
| Informed consent | X | |||||
| Allocation | X | |||||
| INTERVENTIONS |
|
|||||
| PMR + GI (TG1) | ||||||
| H + GI (TG2) | ||||||
| Control groups |
|
|||||
| Active (ACG) | ||||||
| Passive (PCG) | ||||||
| ASSESSMENTS | ||||||
| Sociodemographic data | X | |||||
| Health literacy | X | |||||
| Clinical data (PEDIS) | X | X | X | |||
| DFU evolution/healing a | X | X | X | |||
| Impact of DFU on QoL | X | X | X | |||
| Mental and physical QoL | X | X | X | |||
| Perceived stress | X | X | X | |||
| Psychological morbidity | X | X | X | |||
| DFU representations a | X | X | X | |||
| Blood pressure b | X | X | X | |||
| Heart rate b | X | X | X | |||
| Biochemical parameter | X | X | X | |||
| Inflammatory markers | X | X | X | |||
| Angiogenic markers | X | X | X | |||
| miRNAs | X | X | X | |||
| Immune cells | X | X | X | |||
| Semi-structured interviews | X | |||||
QoL—quality of life; PMR + GI—progressive muscular relaxation with guided imagery; H + GI—hypnosis with guided imagery; ACG—active control group; PCG—passive control group; PEDIS—Perfusion, Extent, Depth, Infection, and Sensation; DFU—diabetic foot ulcer. a In T1 and T2, when the DFU is healed, the DFU progression and DFU representations are not assessed. b Blood pressure and heart rate are assessed before and after each intervention (PMR + GI and H + GI) and placebo (ACG) session.