Diabetic Foot Ulcer (DFU), Neuropathy (Disorder)
Conditions
Keywords
diabetic foot ulcer, diabetes mellitus, foot ankle exercise, neuropathy diabetes
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
Interventions
OTHERfoot-ankle exercise
The exercise was done 3 times a week (15x/until they tired x 2set). The exercise used a elastic band with difference thickness (0,5 mm in 12 weeks and 0,65 mm in nine month)
Sponsors
St Elisabeth School Health Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* type 2 diabetes * can walk minimal 10 meters * neuropathy diabetic
Exclusion criteria
* stroke * active ulcer * fracture on foot area * diabetic ulcer history
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| diabetic foot ulcer (DFU) incidence | 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
| Measure | Time frame | Description |
|---|---|---|
| control glyacemic | 0, 12 weeks, and a year | HbA1c levels, which are the level of blood sugar control over a period of time. 3 months, measured by analyzing blood serum in a laboratory using the National Glycohemoglobin Standardization Program (NGSP). |
| brain derived neurotrophic factor | 0, 12 weeks, and a year | BDNF levels, which are defined as biomolecular markers that can indicate the severity of diabetic neuropathy, as measured by analyzing blood serum using the ELIZA technique |
| walking speed | 0, 12 weeks, and a year | Walking speed is the ratio between times measured while walking in second as fast as possible on a flat and flat trajectory at a certain distance. A track distance used in the study was 5 meter. The time of waking was measured using stopwatch |
| diabetic neuropathy examination score | 0, 12 weeks, and a year | The accumulation score of the result measurement consists of eight item, two testing muscle strength, one a tendon reflex, and five sensation. The min-max score is 0-16. The higher the score indicates the more severe the neuropathy. The score was determined by doing a physical examination. |
| callus insidence | 0, 12 weeks, and a year | Callus is the thickness of the plantar skin area that can be determined by inspection |
| neuropathy symptom score | 0, 12 weeks, and a year | The accumulation score of the result measurement consists of sixteen item about the symptom of neuropathy. The min-max score is 0-16. The more score indicates the more severe of neuropathy. The score was determined by interviewing the patient |
| foot ankle range of motion | 0, 12 weeks, and a year | ankle range of motion, which is the degree of joint movement in the feet during flexion, extension, inversion, and eversion, as measured using digital goniometry |
Countries
Indonesia
Outcome results
None listed