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Active, Not Recruiting

NCT Number: NCT07229794

Effect of Foot-ankle Exercise Using Elastic Band

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetic Foot Ulcer (DFU) Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nervous System Diseases Neuromuscular Diseases Neuropathy (Disorder) Nutritional and Metabolic Diseases Peripheral Nervous System Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elisabeth clinic

Semarang, Central Java, 50231, Indonesia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • type 2 diabetes
  • can walk minimal 10 meters
  • neuropathy diabetic

Exclusion criteria

  • stroke
  • active ulcer
  • fracture on foot area
  • diabetic ulcer history

Treatment and study plan

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)

Primary outcomes

  1. 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

  1. diabetic neuropathy examination score

    Time frame: 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.

  2. control glyacemic

    Time frame: 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).

  3. brain derived neurotrophic factor

    Time frame: 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

  4. walking speed

    Time frame: 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

  5. foot ankle range of motion

    Time frame: 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

  6. callus insidence

    Time frame: 0, 12 weeks, and a year

    Callus is the thickness of the plantar skin area that can be determined by inspection

  7. neuropathy symptom score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

St Elisabeth School Health Science

Other

Registry information

Official study title

Effect of Foot-ankle Exercise Using Elastic Band on Diabetic Foot Ulcer Incidence in Patient With Diabetes Neuropathy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 17, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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