Status:
COMPLETED
Contribution of Psychological Factors in the Healing of the Diabetic Foot Ulcer
Lead Sponsor:
University of Minho
Collaborating Sponsors:
Foundation for Science and Technology, Portugal
Conditions:
Diabetes Mellitus
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Diabetic foot ulcers (DFU) are one of the most serious complications of diabetes and can lead to amputations in 85% of cases, resulting in physical, psychological, family, social and economic conseque...
Detailed Description
General Aim: This RCT aims to assess the effectiveness of a muscle relaxation intervention with guided imagery (EG1) compared to hypnosis with guided imagery intervention (EG2) and a neutral guided i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2022
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT04698720
Start Date
February 1 2019
End Date
July 25 2022
Last Update
May 8 2024
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital de Braga
Braga, Portugal, 4710-243
2
Clínica do Pé Diabético, Centro Hospitalar do Tâmega e Sousa
Penafiel, Portugal, 4564-007
3
Centro Hospitalar Universitário do Porto
Porto, Portugal, 4099-001