Contribution of Psychological Factors in the Healing of the Diabetic Foot Ulcer
Diabetes Mellitus, Diabetic Foot Ulcer
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetic Foot Ulcer, Ulcer Healing, Quality of Life, Hypnosis, Relaxation
Eligibility Criteria
Inclusion Criteria:
- 18 years old or older;
- Diabetes Mellitus diagnosis;
- Diagnosis of Diabetic Foot;
- Having one or two active chronic ulcers (> 6 weeks and < 14 weeks) at the time of baseline assessment;
- Being followed at the Multidisciplinary Consultation of the Diabetic Foot from the Centro Hospitalar Universitário do Porto (CHUP), at the Diabetic Foot Clinic from the Centro Hospitalar do Tâmega e Sousa (CHTS) and from the Multidisciplinary Consultation of the Diabetic Foot of the Hospital de Braga (HB);
- Presenting clinical levels of stress (scores > 13 for males and > 17 for females on the Perceived Stress Scale) or anxiety or depression (scores > 11 on Hospital Anxiety and Depression Scale);
- Providing written informed consent.
Exclusion Criteria:
- The active DFU at the time of the assessment being a relapse;
- Having more than two DFUs at the time of baseline assessment;
- Being on hemodialysis treatment;
- Presence of psychosis or dementia described in the patient's medical record;
- Having cancer disease;
- Having undergone a transplant;
- Receiving psychological counselling at the time of the assessment.
For the RCT qualitative nested study, twelve participants that completed at least 75% of the treatment or placebo sessions, and that report having a informal/ family caregiver will be invite the participate. Participants will be selected according to the following criteria:
- Two typical cases of successful and unsuccessful patients with neuropathic foot, defined by the presence of neuropathic pain (e.g., heat, tingling, electrical shock), presence of distal pulses by palpation, and loss of protective sensitivity;
- Two typical cases of successful and unsuccessful patients with neuroischemic foot, defined by the presence of peripheral artery disease, intense-variable pain, absence of distal pulses by palpation, and variable protective sensitivity.
Sites / Locations
- Hospital de Braga
- Clínica do Pé Diabético, Centro Hospitalar do Tâmega e Sousa
- Centro Hospitalar Universitário do Porto
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Placebo Comparator
No Intervention
Muscle Relaxation with Guided Imagery
Hypnosis with Guided imagery
Active Control Group
Passive Control Group
Participants in the Experimental Group 1 will receive four individual 45-minute sessions, every two weeks, of progressive muscle relaxation intervention with guided imagery focused on ulcer healing, carried out by the Psychologist responsible for implementing the project, on the day of the Diabetic Foot appointments.
Participants in the Experimental Group 2 will receive a four individual 45-minute sessions, every two weeks, of hypnosis intervention with guided imagery focused on ulcer healing, carried out by the qualified Hypnotherapists external to the research study, on the day of the Diabetic Foot appointments.
Participants in the ACG will receive four individual 45-minute sessions of neutral guided imagery placebo focused on the patient's life before the foot ulcer, carried out by the Psychologist responsible for implementing the project, on the day of the Diabetic Foot appointments.
Participants in the PCG will not receive any intervention or placebo session.