Diabetic Foot UlcerNCT05422846
Investigation of the Effects of Different Exercise on Wound Healing in Patients wıth Diabetic Foot Wounds
A study testing standard treatment, aerobic exercise and exercise protocol in people with Diabetic Foot Ulcer and Wound, run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
Diabetic foot ulcers are a common complication of diabetes mellitus and are associated with delayed wound healing, impaired quality of life, and an increased risk of lower extremity amputation. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Diabetic Foot Ulcer, Wound
- What is being tested?
- standard treatment, aerobic exercise and exercise protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 1 Jul 2023
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults diagnosed with type 2 diabetes mellitus and presenting with a diabetic foot ulcer.
- Presence of a Wagner grade 1 or grade 2 diabetic foot ulcer.
- Absence of severe musculoskeletal, cardiovascular, neurological, or other systemic diseases that could interfere with participation in the study or affect the study outcomes.
- Ability to communicate effectively and comply with study procedures.
- Receiving the same standard diabetic foot wound care protocol throughout the study.
- Not receiving any additional treatment or intervention that could influence wound healing during the study period.
Who cannot join
- Individuals with a diagnosed psychiatric disorder.
- Individuals who have received physiotherapy treatment within the previous 3 months.
- Individuals with an acute infection.
- Individuals with a toe pressure <40 mmHg.
- Individuals diagnosed with Charcot foot and/or osteomyelitis.
- Individuals with venous leg ulcers.
- Individuals with morbid obesity (body mass index [BMI] >40 kg/m²).
- Individuals with proliferative diabetic retinopathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Different Exercise Training on Wound Healing ın Patients With Diabetic Foot Ulcer
Diabetic foot ulcers are a common complication of diabetes mellitus and are associated with delayed wound healing, impaired quality of life, and an increased risk of lower extremity amputation. Although regular exercise is recommended for people with diabetes, evidence regarding the safety and effectiveness of structured exercise therapy in individuals with diabetic foot ulcers remains limited.
This randomized controlled trial aims to evaluate the effects of two different exercise interventions on wound healing and quality of life in adults with diabetic foot ulcers. Participants are randomly assigned to one of three groups: a structured exercise group, an aerobic exercise group, or a standard care control group. The intervention lasts 12 weeks, with supervised exercise sessions twice weekly. Outcomes, including ulcer surface area, ulcer depth, quality of life, sleep quality, and kinesiophobia, are assessed at baseline, Week 4, Week 8, and Week 12.
- Conditions
- Diabetic Foot Ulcer, Wound
- Being tested
- standard treatment, aerobic exercise, exercise protocol
- Keywords
- diabetes mellitus, exercise, ulcer
- Medical subject headings
- Diabetic Foot, Wounds and Injuries, Diabetes Mellitus, Motor Activity, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard treatmentOther
Also called control
Participants received a structured exercise programme supervised by a physiotherapist twice weekly for 12 weeks in addition to standard diabetic foot ulcer care.
aerobic exerciseOther
The aerobic exercise group will be provided with the necessary approaches for diabetic foot ulcer care and in addition to diaphragmatic breathing exercises, they will be provided with aerobic exercise twice a week with a physiotherapist.
exercise protocolOther
The protocol exercise group will be provided with the necessary approaches for diabetic foot ulcer care and exercises suitable for the physical condition of the wound and the patient, in addition to diaphragmatic breathing exercises. This group will also work with a physiotherapist twice a week.
| Study group | Role | What they receive |
|---|---|---|
| exercise protocol group | Experimental | Participants received a supervised structured exercise programme tailored to ulcer status and individual physical capacity twice weekly for 12 weeks in addition to standard diabetic foot ulcer care. Receives: Other: exercise protocol |
| aerobic exercise group | Experimental | Participants received supervised aerobic exercise using a bicycle ergometer twice weekly for 12 weeks in addition to standard diabetic foot ulcer care. Receives: Other: aerobic exercise |
| control group | Experimental | Participants received standard diabetic foot ulcer care according to institutional practice without structured exercise therapy. Receives: Other: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
ulcer area (mm²)
Ulcer surface area measured using ImageJ software.
Measured: Baseline, Week 4, Week 8, and Week 12
ulcer depth (mm)
Ulcer depth measured with sterile wound stick
Measured: Baseline and Week 12
Secondary outcomes (2)
quality of life score
Ferrans and Powers Quality of Life Index - Diabetes Version
Measured: Baseline and Week 12
sleep quality score
investigating the sleep quality of patients with the Pittsburgh sleep quality index
Measured: initial assessment - 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Aug 2022
- Primary completion1 Feb 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies 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
- Participants were randomly assigned to one of three parallel groups: a structured exercise group, a conventional aerobic exercise group, or a standard care control group.
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Enzin, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422846
- Sponsor's protocol ID
- diabetic rehabilitation
- Status last verified
- Jul 2023
- First submitted
- 6 Jun 2022
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Different Exercise Training on Wound Healing ın Patients With Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT05422846
- Acronym / sponsor ID
- diabetic rehabilitation
- Conditions
- Diabetic Foot Ulcer, Wound
- Keywords
- diabetes mellitus, exercise, ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 21 Jun 2022 (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.
Diabetic foot ulcers are a common complication of diabetes mellitus and are associated with delayed wound healing, impaired quality of life, and an increased risk of lower extremity amputation. Although regular exercise is recommended for people with diabetes, evidence regarding the safety and effectiveness of structured exercise therapy in individuals with diabetic foot ulcers remains limited.
This randomized controlled trial aims to evaluate the effects of two different exercise interventions on wound healing and quality of life in adults with diabetic foot ulcers. Participants are randomly assigned to one of three groups: a structured exercise group, an aerobic exercise group, or a standard care control group. The intervention lasts 12 weeks, with supervised exercise sessions twice weekly. Outcomes, including ulcer surface area, ulcer depth, quality of life, sleep quality, and kinesiophobia, are assessed at baseline, Week 4, Week 8, and Week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were randomly assigned to one of three parallel groups: a structured exercise group, a conventional aerobic exercise group, or a standard care control group.
| Arm | Type | Receives |
|---|---|---|
| exercise protocol group | Experimental | Other: exercise protocolParticipants received a supervised structured exercise programme tailored to ulcer status and individual physical capacity twice weekly for 12 weeks in addition to standard diabetic foot ulcer care. |
| aerobic exercise group | Experimental | Other: aerobic exerciseParticipants received supervised aerobic exercise using a bicycle ergometer twice weekly for 12 weeks in addition to standard diabetic foot ulcer care. |
| control group | Experimental | Other: standard treatmentParticipants received standard diabetic foot ulcer care according to institutional practice without structured exercise therapy. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults diagnosed with type 2 diabetes mellitus and presenting with a diabetic foot ulcer.
- Presence of a Wagner grade 1 or grade 2 diabetic foot ulcer.
- Absence of severe musculoskeletal, cardiovascular, neurological, or other systemic diseases that could interfere with participation in the study or affect the study outcomes.
- Ability to communicate effectively and comply with study procedures.
- Receiving the same standard diabetic foot wound care protocol throughout the study.
Key exclusion criteria (8 listed)
- Individuals with a diagnosed psychiatric disorder.
- Individuals who have received physiotherapy treatment within the previous 3 months.
- Individuals with an acute infection.
- Individuals with a toe pressure <40 mmHg.
- Individuals diagnosed with Charcot foot and/or osteomyelitis.
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 |
|---|---|---|
| standard treatmentAlso: controlParticipants received a structured exercise programme supervised by a physiotherapist twice weekly for 12 weeks in addition to standard diabetic foot ulcer care. | Other | control group |
| aerobic exerciseThe aerobic exercise group will be provided with the necessary approaches for diabetic foot ulcer care and in addition to diaphragmatic breathing exercises, they will be provided with aerobic exercise twice a week with a physiotherapist. | Other | aerobic exercise group |
| exercise protocolThe protocol exercise group will be provided with the necessary approaches for diabetic foot ulcer care and exercises suitable for the physical condition of the wound and the patient, in addition to diaphragmatic breathing exercises. This group will also work with a physiotherapist twice a week. | Other | exercise protocol group |
Primary outcome
ulcer area (mm²)
Time frame: Baseline, Week 4, Week 8, and Week 12
Ulcer surface area measured using ImageJ software.
ulcer depth (mm)
Time frame: Baseline and Week 12
Ulcer depth measured with sterile wound stick
2 secondary outcomes
quality of life score
Time frame: Baseline and Week 12
sleep quality score
Time frame: initial assessment - 12th week
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 29 Jul 2026.
- Individual participant dataSharing planned: No
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard treatment, aerobic exercise and exercise protocol in people with Diabetic Foot Ulcer and Wound, run by Harran University at 1 site in Turkey (Türkiye).
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 6 inclusion and 8 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 29 Jul 2026. 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 Turkey (Türkiye). 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?
ulcer area (mm²) (time frame: Baseline, Week 4, Week 8, and Week 12). The study lists 2 primary outcomes in all. 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 29 Jul 2026.