The effect of psychological intervention on the quality of life and wound healing in patients with diabetic foot ulcer.

Rationale: The quality of life of patients with a diabetic foot ulcer is poor. This is due to physical limitations and emotional problems. Medical devices help patients overcome their physical limitations. However, there is no mental help program for these patients yet.



Objective: The aim of this study is to evaluate the effect of psychological intervention for the quality of life and wound healing in patients with a diabetic foot ulcer.



Study design: A single-center, randomized, prospective cohort study.



Study population: Patients visiting the multidisciplinary outpatient diabetic foot clinic with ≥ 1 foot ulcer on or below the malleolus, who are diagnosed with diabetes mellitus and aged between 18 and 65 years are eligible for inclusion.



Intervention: One group of patients will receive therapy for 45 minutes once a week for 8 weeks. The therapy is including cognitive behavioral therapy, lifestyle and stress management, coping behavior therapy and treatment for depression. The other group will not receive psychological therapy.



Main endpoints: The primary outcome is the score on the Short form 36 (SF-36) 6 months after finishing psychological intervention. Secondary outcomes are the result of Diabetic Foot Ulcer scale short form (DFS-SF) after finishing therapy and after 6 months follow-up, the occurrence of wound healing and the occurrence of minor and major amputation.

The quality of life and wound healing of patients with a diabetic foot ulcer will improve after undergoing a psychological intervention.

8 months after randomization

A medical psychologist will perform therapy for 45 minutes 2 times a week for 8 weeks. The therapy is including cognitive behavioral therapy, lifestyle and stress management, coping behavior therapy and treatment for depression. Hereafter, patients will complete the DFS-SF and SF-36 survey again.