Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT04698720
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04698720
Study Brief:
Protocol Section:
NCT04698720