Diabetic Foot Ulcer (DFU)NCT07229794
Effect of Foot-ankle Exercise Using Elastic Band
A study testing foot-ankle exercise in people with Diabetic Foot Ulcer (DFU) and Neuropathy (Disorder), run by St Elisabeth School Health Science at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Foot Ulcer (DFU), Neuropathy (Disorder)
- What is being tested?
- foot-ankle exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- type 2 diabetes
- can walk minimal 10 meters
- neuropathy diabetic
Who cannot join
- stroke
- active ulcer
- fracture on foot area
- diabetic ulcer history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Diabetic Foot Ulcer (DFU), Neuropathy (Disorder)
- Being tested
- foot-ankle exercise
- Keywords
- diabetic foot ulcer, diabetes mellitus, foot ankle exercise, neuropathy diabetes
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foot-ankle exerciseOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: for a year
Secondary outcomes (7)
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.
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 0, 12 weeks, and a year
callus insidence
Callus is the thickness of the plantar skin area that can be determined by inspection
Measured: 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
Measured: 0, 12 weeks, and a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start1 Jul 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot Ulcer (DFU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Elisabeth School Health Science
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Suryani, St Elisabeth School Health Science
- Investigators
- maria suryani, Principal investigator, stikes elisabeth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229794
- Sponsor's protocol ID
- Stikes Elisabeth11
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28614678
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Foot-ankle Exercise Using Elastic Band on Diabetic Foot Ulcer Incidence in Patient With Diabetes Neuropathy
- ClinicalTrials.gov ID
- NCT07229794
- Acronym / sponsor ID
- Stikes Elisabeth11
- Conditions
- Diabetic Foot Ulcer (DFU), Neuropathy (Disorder)
- Keywords
- diabetic foot ulcer, diabetes mellitus, foot ankle exercise, neuropathy diabetes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- St Elisabeth School Health ScienceUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| foot-ankle exercise group | Experimental | Other: foot-ankle exerciseThe 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- type 2 diabetes
- can walk minimal 10 meters
- neuropathy diabetic
Key exclusion criteria (4 listed)
- stroke
- active ulcer
- fracture on foot area
- diabetic ulcer history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| foot-ankle exerciseThe 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) | Other | foot-ankle exercise group |
Primary outcome
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
7 secondary outcomes
diabetic neuropathy examination score
Time frame: 0, 12 weeks, and a year
control glyacemic
Time frame: 0, 12 weeks, and a year
brain derived neurotrophic factor
Time frame: 0, 12 weeks, and a year
walking speed
Time frame: 0, 12 weeks, and a year
foot ankle range of motion
Time frame: 0, 12 weeks, and a year
callus insidence
Time frame: 0, 12 weeks, and a year
neuropathy symptom score
Time frame: 0, 12 weeks, and a year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Background: PubMed 28614678Armstrong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
maria suryani principal investigator
stikes elisabeth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing foot-ankle exercise in people with Diabetic Foot Ulcer (DFU) and Neuropathy (Disorder), run by St Elisabeth School Health Science at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diabetic foot ulcer (DFU) incidence (time frame: for a year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07229794, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.