Effect of Foot-ankle Exercise Using Elastic Band

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetic Foot Ulcer (DFU); Neuropathy (Disorder)
• Intervention / Treatment: Other: foot-ankle exercise

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Central Java
    • Semarang, Central Java, Indonesia, 50231
      • Elisabeth clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: foot-ankle exercise group; 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.	Other: foot-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)
No Intervention: control group; Patient will receive usual care, with include pharmacological treatment and self care guidelines, which are maintained in both group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: St Elisabeth School Health Science
• Investigators: Principal Investigator: maria suryani, stikes elisabeth

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: September 22, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: diabetes mellitus; diabetic foot ulcer; foot ankle exercise; neuropathy diabetes
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neuromuscular Diseases; Metabolic Diseases; Peripheral Nervous System Diseases; Glucose Metabolism Disorders; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Foot Ulcer; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Diabetes Mellitus; Diabetic Neuropathies; Diabetic Foot
• Other Study ID Numbers: Stikes Elisabeth11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No