Peripheral Artery Disease (PAD)NCT07262203
Effect of Diabetic Foot Exercises on Peripheral Vascular Status in Type 2 Diabetes Mellitus Patients
A study testing Diabetic Foot Exercise Program in people with Peripheral Artery Disease (PAD) and Diabetes Mellitus Type 2, run by Universitas Muhammadiyah Surakarta at 1 site in Indonesia.
Trial summary
This randomized controlled trial aims to evaluate the effectiveness of diabetic foot exercises on peripheral vascular status among patients with type 2 diabetes mellitus. Peripheral artery disease is a common complication of diabetes and contributes to reduced mobility and increased risk of ulcers, ischemia, and… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Peripheral Artery Disease (PAD), Diabetes Mellitus Type 2, Diabetic Foot Circulation Impairment
- What is being tested?
- Diabetic Foot Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Apr 2024to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged > 50 years
- Diagnosed with Type 2 Diabetes Mellitus for ≥ 5 years
- Able to walk independently
- Willing to participate for the full 3-month intervention period
- Provided written informed consent
Who cannot join
- patients who unable to walk independently, had lower limb pain, severe arthritis, cardiovascular or neurological disorders, limited physical activity, or cognitive dysfunction that impaired their ability to follow instructions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Diabetic Foot Exercises on Peripheral Vascular Status Among Patients With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effectiveness of diabetic foot exercises on peripheral vascular status among patients with type 2 diabetes mellitus. Peripheral artery disease is a common complication of diabetes and contributes to reduced mobility and increased risk of ulcers, ischemia, and amputation. Early identification and non-pharmacological interventions such as structured lower extremity exercises may help improve peripheral circulation.
In this study, 44 adults with type 2 diabetes mellitus who met the inclusion criteria were randomly assigned to either an intervention group receiving diabetic foot exercises or a control group performing regular physical activity of similar frequency and duration. The exercise protocol used in the intervention group was adapted from the Joslin Diabetes Center and included balance, strengthening, and ankle-foot mobility exercises. The intervention lasted for 3 months.
Read more
Peripheral vascular status was assessed using the ankle-brachial index (ABI) measured with a Doppler device at baseline and after 3 months. The study found that participants in the intervention group demonstrated a significant improvement in ABI values compared with the control group, indicating enhanced lower-limb blood flow.
This trial provides evidence that diabetic foot exercises are a simple, low-cost, and feasible intervention to improve peripheral vascular circulation in patients with type 2 diabetes mellitus, particularly in settings with limited resources.
Read the detailed description
This randomized controlled trial was conducted to determine the effectiveness of diabetic foot exercises in improving peripheral vascular status among patients with type 2 diabetes mellitus (T2DM). Diabetes mellitus is a chronic metabolic disorder associated with multiple vascular complications, including peripheral artery disease (PAD). PAD in diabetic patients is frequently asymptomatic during the early stages, yet it substantially increases the risk of ischemia, ulceration, and lower-limb amputation. Regular physical activity and targeted exercises have been shown to improve circulation and functional capacity. However, evidence regarding the effects of specific diabetic foot exercise programs on peripheral vascular status remains limited in Indonesia.
A total of 44 participants with T2DM were recruited from PERSADIA at Dr. Moewardi Hospital, Central Java, Indonesia. Participants were randomly assigned to either the treatment group (n = 22) or control group (n = 22) using a card-shuffle randomization method. Inclusion criteria included age above 50 years and a diagnosis of T2DM for at least 5 years. Exclusion criteria included inability to walk independently, lower extremity pain, severe arthritis, neurological or cardiovascular disorders, limited physical activity, or cognitive impairment. All participants provided written informed consent before enrollment.
The intervention consisted of a structured diabetic foot exercise program adapted from the Joslin Diabetes Center, involving quadriceps strengthening, balance exercises, ankle and foot mobility movements, and kicking exercises. Participants in the intervention group were instructed to perform the exercises daily for approximately 30 minutes over a period of 3 months, with monitoring to ensure safety. The control group participated in regular physical activity of similar duration and frequency but without the targeted diabetic foot exercise components.
Peripheral vascular status was assessed through the ankle-brachial index (ABI), using a Doppler device (ES-1000SPM, Hadeco, Japan). ABI measurements were taken at baseline and after 3 months of intervention, following standard procedures, including supine positioning and an initial rest period of five minutes. ABI categories followed established clinical thresholds: normal (0.90-1.30), mild impairment (0.70-0.89), moderate impairment (0.40-0.69), and severe impairment (<0.40).
Data analysis was performed using SPSS, employing paired t-tests for within-group comparisons and independent t-tests for between-group differences. The results demonstrated a significant improvement in ABI values in the intervention group (from 0.90 ± 0.05 to 0.96 ± 0.06), compared to minimal changes in the control group (from 0.90 ± 0.04 to 0.91 ± 0.05). These findings suggest that diabetic foot exercises can effectively enhance peripheral vascular function.
This study highlights that diabetic foot exercises offer a practical, low-cost, and accessible method for improving lower-extremity circulation in people with type 2 diabetes. Unlike intensive exercise programs requiring specialized equipment or supervision, this intervention is feasible for implementation in community settings and resource-limited environments. Although the study involved a relatively small sample size, the statistical power was acceptable, and the results align with previous evidence showing that lower extremity exercise improves vascular health.
Future studies with larger populations and longer follow-up periods are recommended to explore the long-term vascular and metabolic benefits of diabetic foot exercise programs
- Conditions
- Peripheral Artery Disease (PAD), Diabetes Mellitus Type 2, Diabetic Foot Circulation Impairment
- Being tested
- Diabetic Foot Exercise Program
- Keywords
- diabetic foot exercises, peripheral vascular, ankle brachial index, Type 2 Diabetes Mellitus
- Medical subject headings
- Peripheral Arterial Disease, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetic Foot Exercise ProgramBehavioural
Also called Diabetic Foot Exercises, Foot Exercise Regimen
A structured diabetic foot exercise program adapted from the Joslin Diabetes Center protocol. The regimen includes quadriceps strengthening, balance exercises, ankle and foot mobility movements, and kicking exercises. Participants perform the exercises for approximately 30 minutes daily over 3 months under monitoring by the research team. The exercises aim to improve peripheral vascular status and lower-limb circulation. Ankle-brachial index is measured at baseline and after 3 months using a Doppler device
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Foot Exercise Intervention | Experimental | Participants performed a structured diabetic foot exercise program adapted from the Joslin Diabetes Center regimen. Exercises included quadriceps strengthening, balance exercises, ankle and foot mobility movements, and kicking exercises. The program was conducted for 3 months, approximately 30 minutes per day, with monitoring by the research team to maintain safety and adherence. All participants in this arm had type 2 diabetes mellitus. The primary outcome (ankle-brachial index) was measured at baseline and after 3 months. Receives: Behavioral: Diabetic Foot Exercise Program |
| Control - Usual Physical Activity | No intervention | Participants continued their usual physical activities with similar recommended frequency and duration as the intervention group but did not receive the structured diabetic foot exercise program. They continued routine diabetes care and any prescribed DM medications. The control group served as a comparator to assess the effect of the diabetic foot exercise program on ankle-brachial index over 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ankle-Brachial Index (ABI)
Ankle-Brachial Index (ABI) is measured using a handheld Doppler device (ES-1000SPM, Hadeco, Japan). ABI is calculated as the highest ankle systolic pressure (posterior tibial or dorsalis pedis) divided by the highest brachial systolic pressure. Measurements are taken in supine position after 5 minutes rest. ABI values reflect peripheral vascular status, categorized as normal (0.90-1.30), mild (0.70-0.89), moderate (0.40-0.69), and severe (<0.40). Primary analysis compares the change in ABI from baseline to 3 months between intervention and control groups
Measured: Baseline and 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Apr 2024
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery Disease (PAD)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel-group controlled trial with two arms (intervention vs control). Participants were randomly allocated (1:1) using a card-shuffle randomization method. The intervention group performed a structured diabetic foot exercise program derived from Joslin Diabetes Center guidelines for three months (≈30 minutes/day, supervised monitoring), while the control group continued usual physical activity of comparable frequency and duration without the specific diabetic foot exercise program. Primary outcome (ankle-brachial index) measured at baseline and after 3 months using Doppler device
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Muhammadiyah Surakarta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahrun Nur Rosyid, Universitas Muhammadiyah Surakarta
- Investigators
- Faculty of Health Sciences FIK UMS, Principal investigator, Universitas Muhammadiyah Surakarta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262203
- Sponsor's protocol ID
- UMS-DFET2DM-2024
- Status last verified
- Nov 2025
- First submitted
- 22 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The researchers do not plan to share individual participant data because the dataset contains sensitive health information and no data-sharing repository has been prepared for this study.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Diabetic Foot Exercises on Peripheral Vascular Status Among Patients With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07262203
- Acronym / sponsor ID
- UMS-DFET2DM-2024
- Conditions
- Peripheral Artery Disease (PAD), Diabetes Mellitus Type 2, Diabetic Foot Circulation Impairment
- Keywords
- diabetic foot exercises, peripheral vascular, ankle brachial index, Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Universitas Muhammadiyah SurakartaUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 3 Dec 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.
This randomized controlled trial aims to evaluate the effectiveness of diabetic foot exercises on peripheral vascular status among patients with type 2 diabetes mellitus. Peripheral artery disease is a common complication of diabetes and contributes to reduced mobility and increased risk of ulcers, ischemia, and amputation. Early identification and non-pharmacological interventions such as structured lower extremity exercises may help improve peripheral circulation.
In this study, 44 adults with type 2 diabetes mellitus who met the inclusion criteria were randomly assigned to either an intervention group receiving diabetic foot exercises or a control group performing regular physical activity of similar frequency and duration. The exercise protocol used in the intervention group was adapted from the Joslin Diabetes Center and included balance, strengthening, and ankle-foot mobility exercises. The intervention lasted for 3 months.
Peripheral vascular status was assessed using the ankle-brachial index (ABI) measured with a Doppler device at baseline and after 3 months. The study found that participants in the intervention group demonstrated a significant improvement in ABI values compared with the control group, indicating enhanced lower-limb blood flow.
This trial provides evidence that diabetic foot exercises are a simple, low-cost, and feasible intervention to improve peripheral vascular circulation in patients with type 2 diabetes mellitus, particularly in settings with limited resources.
Detailed description
This randomized controlled trial was conducted to determine the effectiveness of diabetic foot exercises in improving peripheral vascular status among patients with type 2 diabetes mellitus (T2DM). Diabetes mellitus is a chronic metabolic disorder associated with multiple vascular complications, including peripheral artery disease (PAD). PAD in diabetic patients is frequently asymptomatic during the early stages, yet it substantially increases the risk of ischemia, ulceration, and lower-limb amputation. Regular physical activity and targeted exercises have been shown to improve circulation and functional capacity. However, evidence regarding the effects of specific diabetic foot exercise programs on peripheral vascular status remains limited in Indonesia.
A total of 44 participants with T2DM were recruited from PERSADIA at Dr. Moewardi Hospital, Central Java, Indonesia. Participants were randomly assigned to either the treatment group (n = 22) or control group (n = 22) using a card-shuffle randomization method. Inclusion criteria included age above 50 years and a diagnosis of T2DM for at least 5 years. Exclusion criteria included inability to walk independently, lower extremity pain, severe arthritis, neurological or cardiovascular disorders, limited physical activity, or cognitive impairment. All participants provided written informed consent before enrollment.
The intervention consisted of a structured diabetic foot exercise program adapted from the Joslin Diabetes Center, involving quadriceps strengthening, balance exercises, ankle and foot mobility movements, and kicking exercises. Participants in the intervention group were instructed to perform the exercises daily for approximately 30 minutes over a period of 3 months, with monitoring to ensure safety. The control group participated in regular physical activity of similar duration and frequency but without the targeted diabetic foot exercise components.
Peripheral vascular status was assessed through the ankle-brachial index (ABI), using a Doppler device (ES-1000SPM, Hadeco, Japan). ABI measurements were taken at baseline and after 3 months of intervention, following standard procedures, including supine positioning and an initial rest period of five minutes. ABI categories followed established clinical thresholds: normal (0.90-1.30), mild impairment (0.70-0.89), moderate impairment (0.40-0.69), and severe impairment (<0.40).
Data analysis was performed using SPSS, employing paired t-tests for within-group comparisons and independent t-tests for between-group differences. The results demonstrated a significant improvement in ABI values in the intervention group (from 0.90 ± 0.05 to 0.96 ± 0.06), compared to minimal changes in the control group (from 0.90 ± 0.04 to 0.91 ± 0.05). These findings suggest that diabetic foot exercises can effectively enhance peripheral vascular function.
This study highlights that diabetic foot exercises offer a practical, low-cost, and accessible method for improving lower-extremity circulation in people with type 2 diabetes. Unlike intensive exercise programs requiring specialized equipment or supervision, this intervention is feasible for implementation in community settings and resource-limited environments. Although the study involved a relatively small sample size, the statistical power was acceptable, and the results align with previous evidence showing that lower extremity exercise improves vascular health.
Future studies with larger populations and longer follow-up periods are recommended to explore the long-term vascular and metabolic benefits of diabetic foot exercise programs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, parallel-group controlled trial with two arms (intervention vs control). Participants were randomly allocated (1:1) using a card-shuffle randomization method. The intervention group performed a structured diabetic foot exercise program derived from Joslin Diabetes Center guidelines for three months (≈30 minutes/day, supervised monitoring), while the control group continued usual physical activity of comparable frequency and duration without the specific diabetic foot exercise program. Primary outcome (ankle-brachial index) measured at baseline and after 3 months using Doppler device
| Arm | Type | Receives |
|---|---|---|
| Diabetic Foot Exercise Intervention | Experimental | Behavioral: Diabetic Foot Exercise ProgramParticipants performed a structured diabetic foot exercise program adapted from the Joslin Diabetes Center regimen. Exercises included quadriceps strengthening, balance exercises, ankle and foot mobility movements, and kicking exercises. The program was conducted for 3 months, approximately 30 minutes per day, with monitoring by the research team to maintain safety and adherence. All participants in this arm had type 2 diabetes mellitus. The primary outcome (ankle-brachial index) was measured at baseline and after 3 months. |
| Control - Usual Physical Activity | No intervention | –Participants continued their usual physical activities with similar recommended frequency and duration as the intervention group but did not receive the structured diabetic foot exercise program. They continued routine diabetes care and any prescribed DM medications. The control group served as a comparator to assess the effect of the diabetic foot exercise program on ankle-brachial index over 3 months |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged > 50 years
- Diagnosed with Type 2 Diabetes Mellitus for ≥ 5 years
- Able to walk independently
- Willing to participate for the full 3-month intervention period
- Provided written informed consent
Key exclusion criteria (1 listed)
- patients who unable to walk independently, had lower limb pain, severe arthritis, cardiovascular or neurological disorders, limited physical activity, or cognitive dysfunction that impaired their ability to follow instructions.
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 |
|---|---|---|
| Diabetic Foot Exercise ProgramAlso: Diabetic Foot Exercises, Foot Exercise RegimenA structured diabetic foot exercise program adapted from the Joslin Diabetes Center protocol. The regimen includes quadriceps strengthening, balance exercises, ankle and foot mobility movements, and kicking exercises. Participants perform the exercises for approximately 30 minutes daily over 3 months under monitoring by the research team. The exercises aim to improve peripheral vascular status and lower-limb circulation. Ankle-brachial index is measured at baseline and after 3 months using a Doppler device | Behavioural | Diabetic Foot Exercise Intervention |
Primary outcome
Change in Ankle-Brachial Index (ABI)
Time frame: Baseline and 3 months after intervention
Ankle-Brachial Index (ABI) is measured using a handheld Doppler device (ES-1000SPM, Hadeco, Japan). ABI is calculated as the highest ankle systolic pressure (posterior tibial or dorsalis pedis) divided by the highest brachial systolic pressure. Measurements are taken in supine position after 5 minutes rest. ABI values reflect peripheral vascular status, categorized as normal (0.90-1.30), mild (0.70-0.89), moderate (0.40-0.69), and severe (<0.40). Primary analysis compares the change in ABI from baseline to 3 months between intervention and control groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No. The researchers do not plan to share individual participant data because the dataset contains sensitive health information and no data-sharing repository has been prepared for this study.
Related trials for Peripheral Artery Disease (PAD)
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The THOR IDE Study
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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.
Faculty of Health Sciences FIK UMS principal investigator
Universitas Muhammadiyah Surakarta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetic Foot Exercise Program in people with Peripheral Artery Disease (PAD) and Diabetes Mellitus Type 2, run by Universitas Muhammadiyah Surakarta 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 3 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Ankle-Brachial Index (ABI) (time frame: Baseline and 3 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2025.