Effect of Foot-ankle Exercise Using Elastic Band

NCT07229794 | Active Not Recruiting DMC

• 1 other identifier: Stikes Elisabeth11
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetic Foot Ulcer (DFU); Neuropathy (Disorder)

Keywords

diabetic foot ulcer; diabetes mellitus; foot ankle exercise; neuropathy diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

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.

Other: foot-ankle exercise

control group

NO INTERVENTION

Patient will receive usual care, with include pharmacological treatment and self care guidelines, which are maintained in both group

Interventions

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)

foot-ankle exercise group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• St Elisabeth School Health Science: lead

Study Sites (1)

Elisabeth clinic

Semarang, Central Java, 50231, Indonesia

Location

Related Publications (1)

• 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.

  PMID: 28614678 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• maria suryani

  stikes elisabeth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: November 17, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)