Diabetic Foot Ulcer, Wound
Conditions
Keywords
diabetes mellitus, exercise, ulcer
Brief summary
Diabetic foot ulcers are a common complication of diabetes mellitus and are associated with delayed wound healing, impaired quality of life, and an increased risk of lower extremity amputation. Although regular exercise is recommended for people with diabetes, evidence regarding the safety and effectiveness of structured exercise therapy in individuals with diabetic foot ulcers remains limited. This randomized controlled trial aims to evaluate the effects of two different exercise interventions on wound healing and quality of life in adults with diabetic foot ulcers. Participants are randomly assigned to one of three groups: a structured exercise group, an aerobic exercise group, or a standard care control group. The intervention lasts 12 weeks, with supervised exercise sessions twice weekly. Outcomes, including ulcer surface area, ulcer depth, quality of life, sleep quality, and kinesiophobia, are assessed at baseline, Week 4, Week 8, and Week 12.
Interventions
OTHERexercise protocol
The protocol exercise group will be provided with the necessary approaches for diabetic foot ulcer care and exercises suitable for the physical condition of the wound and the patient, in addition to diaphragmatic breathing exercises. This group will also work with a physiotherapist twice a week.
OTHERstandard treatment
Participants received a structured exercise programme supervised by a physiotherapist twice weekly for 12 weeks in addition to standard diabetic foot ulcer care.
OTHERaerobic exercise
The aerobic exercise group will be provided with the necessary approaches for diabetic foot ulcer care and in addition to diaphragmatic breathing exercises, they will be provided with aerobic exercise twice a week with a physiotherapist.
Sponsors
Harran University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants were randomly assigned to one of three parallel groups: a structured exercise group, a conventional aerobic exercise group, or a standard care control group.
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults diagnosed with type 2 diabetes mellitus and presenting with a diabetic foot ulcer. * Presence of a Wagner grade 1 or grade 2 diabetic foot ulcer. * Absence of severe musculoskeletal, cardiovascular, neurological, or other systemic diseases that could interfere with participation in the study or affect the study outcomes. * Ability to communicate effectively and comply with study procedures. * Receiving the same standard diabetic foot wound care protocol throughout the study. * Not receiving any additional treatment or intervention that could influence wound healing during the study period.
Exclusion criteria
* Individuals with a diagnosed psychiatric disorder. * Individuals who have received physiotherapy treatment within the previous 3 months. * Individuals with an acute infection. * Individuals with a toe pressure \<40 mmHg. * Individuals diagnosed with Charcot foot and/or osteomyelitis. * Individuals with venous leg ulcers. * Individuals with morbid obesity (body mass index \[BMI\] \>40 kg/m²). * Individuals with proliferative diabetic retinopathy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ulcer area (mm²) | Baseline, Week 4, Week 8, and Week 12 | Ulcer surface area measured using ImageJ software. |
| ulcer depth (mm) | Baseline and Week 12 | Ulcer depth measured with sterile wound stick |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| quality of life score | Baseline and Week 12 | Ferrans and Powers Quality of Life Index - Diabetes Version |
| sleep quality score | initial assessment - 12th week | investigating the sleep quality of patients with the Pittsburgh sleep quality index |
Countries
Turkey (Türkiye)
Outcome results
None listed