Effect of Foot-ankle Exercise Using Elastic Band on Diabetic Foot Ulcer Incidence in Patient With Diabetes Neuropathy
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- St Elisabeth School Health Science
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- diabetic foot ulcer (DFU) incidence
Overview
Brief Summary
The goal of this clinical trial is to learn if foot-ankle exercise can prevent diabetic foot ulcer incidence in patient with diabetes neuropathy. It will also learn about the effect of foot-ankle exercise on improvement of diabetes neuropathy severity, glycemic control, brain-derived neurotropic factor, walking speed, foot ankle range of motion, callus. The main questions it aims to answer are:
- Does foot-ankle exercise lower the number of diabetic ulcer incidence
- Does foot-ankle exercise lower the diabetes neuropathy severity
- Does foot-ankle exercise improve glycemic control
- Does foot-ankle exercise improve brain-derived neurotrophic factor
- Does foot-ankle exercise improve walking speed
- Does foot-ankle exercise improve foot ankle range of motion
- Does foot-ankle exercise lower the number of callus incidence
Detailed Description
Researchers will compare intervention group foot-ankle exercise used elastic band to a control group to see if foot-ankle exercise work to prevent diabetic foot ulcer incidence in patient with diabetes neuropathy
Participants will:
- Do foot-ankle exercise for three times a week with non-consecutive day for 1 year
- Report the incidence of callus and diabetic foot ulcer whenever they have
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •type 2 diabetes
- •can walk minimal 10 meters
- •neuropathy diabetic
Exclusion Criteria
- •active ulcer
- •fracture on foot area
- •diabetic ulcer history
Outcomes
Primary Outcomes
diabetic foot ulcer (DFU) incidence
Time Frame: for a year
DFU, defined as a wound in the area below the ankle that reaches at least the epidermis and part of the dermis, as diagnosed by an internist
Secondary Outcomes
- diabetic neuropathy examination score(0, 12 weeks, and a year)
- control glyacemic(0, 12 weeks, and a year)
- brain derived neurotrophic factor(0, 12 weeks, and a year)
- walking speed(0, 12 weeks, and a year)
- foot ankle range of motion(0, 12 weeks, and a year)
- callus insidence(0, 12 weeks, and a year)
- neuropathy symptom score(0, 12 weeks, and a year)
Investigators
Maria Suryani
Principal investigator
St Elisabeth School Health Science