Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| foot-ankle exercise group | Experimental | The group will receive usual care with additional food-ankle exercises using elastic band supervised by professional health care three times a week for twelve weeks. After twelve weeks period the patient will continue exercising for the completion of the study (9 month) by them self with the help of foot-ankle exercise video. |
|
| control group | No Intervention | Patient will receive usual care, with include pharmacological treatment and self care guidelines, which are maintained in both group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| foot-ankle exercise | Other | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| diabetic foot ulcer (DFU) incidence | 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 | for a year |
| Measure | Description | Time Frame |
|---|---|---|
| diabetic neuropathy examination score | 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. | 0, 12 weeks, and a year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| maria suryani | stikes elisabeth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elisabeth clinic | Semarang | Central Java | 50231 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28614678 | Background | Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2025 | Oct 7, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D003920 | Diabetes Mellitus |
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| control glyacemic | 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). | 0, 12 weeks, and a year |
| brain derived neurotrophic factor | 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 | 0, 12 weeks, and a year |
| walking speed | 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 | 0, 12 weeks, and a year |
| foot ankle range of motion | 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 | 0, 12 weeks, and a year |
| callus insidence | Callus is the thickness of the plantar skin area that can be determined by inspection | 0, 12 weeks, and a year |
| neuropathy symptom score | 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 | 0, 12 weeks, and a year |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |