Diabetic Foot UlcerNCT06916663
RCT Comparing Upper Body vs. Combined Exercise Protocols During Active Diabetic Foot Ulcer Treatment
A study testing Upper Body Exercise Protocol (UBE), Combined Non-Weight Bearing Exercise Protocol (CE) and Standard Diabetic Foot Ulcer Wound Care (SC) in people with Diabetic Foot Ulcer, run by Al Hayah University In Cairo at 1 site in Egypt.
Trial summary
This randomized controlled trial (RCT) aims to evaluate the effectiveness of two different structured exercise interventions compared to standard care during active diabetic foot ulcer (DFU) treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Upper Body Exercise Protocol (UBE), Combined Non-Weight Bearing Exercise Protocol (CE) and Standard Diabetic Foot Ulcer Wound Care (SC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Apr 2025to 23 Apr 2027
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Adults aged 18 years or older. Diagnosis: Confirmed diagnosis of Type 1 or Type 2 diabetes. Active DFU: Presence of a diabetic foot ulcer under active treatment, as documented by the wound care team.
- Wound Stability: Ulcer size that meets protocol criteria (e.g., <2 cm² or ≥2 cm²) and without critical limb ischemia.
- Ability to Exercise: Medical clearance from a physician to safely participate in unsupervised upper body and non-weight bearing exercises.
- Compliance: Capacity and willingness to adhere to the study protocol, including scheduled exercise sessions and offloading procedures.
- Glycemic Control: Stable glycemic control medications regimen for at least 4 weeks prior to enrollment.
- Informed Consent: Ability to provide written informed consent.
Who cannot join
- Critical DFU Complications: Ulcers with signs of critical limb ischemia, severe infection (e.g., osteomyelitis), or wound deterioration that contraindicates participation.
- Cardiovascular Limitations: Unstable cardiac conditions (e.g., uncontrolled arrhythmias, recent myocardial infarction within 6 months), severe heart failure, or any other condition contraindicating exercise.
- Neurological or Musculoskeletal Limitations: Conditions that significantly impair upper body or core exercise performance (e.g., severe arthritis, recent upper body injury).
- Cognitive Impairment: Significant cognitive or psychiatric disorders that would limit the ability to provide informed consent or adhere to the intervention protocol.
- Concurrent Participation: Enrollment in another clinical trial or exercise program that conflicts with the study protocol.
- Other Medical Risks: Any other condition, as determined by the study physician, that places the participant at increased risk of adverse events during exercise (e.g., severe peripheral vascular disease not amenable to offloading).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohamed ElMeligie, Ph.D contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy, Al Hayah University
Cairo, 12311
Mohamed ElMeligie, Ph.D, 01159880001 ext. +20, mohamed.elmeligie@ahuc.edu.eg
About this study
Official title: A Prospective, Three-Arm, Assessor-Blinded Randomized Controlled Trial Comparing Upper Body Exercise, Combined Non-Weight Bearing Exercise, and Standard Care for Improving Cardiorespiratory Fitness and Supporting Wound Healing in Patients Undergoing Active Diabetic Foot Ulcer Treatment
This randomized controlled trial (RCT) aims to evaluate the effectiveness of two different structured exercise interventions compared to standard care during active diabetic foot ulcer (DFU) treatment. Participants will be allocated to one of three groups: Upper Body Exercise (UBE), Combined Exercise (CE), or Standard Care Control (SC). The interventions are designed to improve cardiorespiratory fitness-as measured by changes in VO₂peak-and other secondary clinical, metabolic, vascular, inflammatory, muscular, and quality-of-life outcomes while ensuring proper offloading and wound management.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Upper Body Exercise Protocol (UBE), Combined Non-Weight Bearing Exercise Protocol (CE), Standard Diabetic Foot Ulcer Wound Care (SC)
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper Body Exercise Protocol (UBE)Behavioural
Participants randomized to the Upper Body Exercise Group will perform a structured, supervised exercise regimen focused exclusively on the upper extremities and core muscles, while rigorously maintaining foot offloading prescribed for diabetic foot ulcers (DFU). This intervention is delivered face-to-face in hospital-based outpatient rehabilitation centers. Sessions are held three times per week for 12 consecutive weeks (total 36 sessions), with each session lasting 45-60 minutes.
Each UBE session comprises a 10-minute warm-up on an arm ergometer at 40-50% of the participant's heart rate reserve (HRR), followed by a circuit of eight upper body and core exercises.
Combined Non-Weight Bearing Exercise Protocol (CE)Behavioural
Participants in the Combined Exercise Group will engage in a structured exercise regimen that integrates upper body, core, and modified lower extremity exercises-all performed in a non-weight bearing or seated position to ensure complete offloading of the affected foot. Sessions are conducted face-to-face in hospital-based rehabilitation centers. Participants attend three sessions per week for 12 weeks (36 sessions total), each lasting 45-60 minutes.
Each session begins with a 10-minute warm-up on an arm ergometer at 40-50% HRR.
Standard Diabetic Foot Ulcer Wound Care (SC)Behavioural
Participants assigned to the Standard Care Control Group will receive comprehensive DFU wound management in accordance with International Working Group on the Diabetic Foot (IWGDF) guidelines. This includes standard offloading strategies (using Total Contact Cast or removable cast walker), regular weekly wound assessments, and debridement if necessary. Diabetes management education is provided along with routine adjustments and monitoring of the offloading device to ensure proper healing support. No structured exercise intervention is added; however, all aspects of care such as continuous glucose monitoring and vascular assessments will be uniformly applied to allow comparison with the exercise groups.
| Study group | Role | What they receive |
|---|---|---|
| Upper Body Exercise Group (UBE): | Experimental | Structured upper extremity and core exercise sessions while maintaining foot offloading. Receives: Behavioral: Upper Body Exercise Protocol (UBE) |
| Combined Exercise Group (CE): | Experimental | Structured non-weight bearing combined exercise including upper body, core, and modified lower extremity exercises while maintaining foot offloading. Receives: Behavioral: Combined Non-Weight Bearing Exercise Protocol (CE) |
| Standard Care Control Group (SC): | Active comparator | Standard wound care without a structured exercise intervention. Receives: Behavioral: Standard Diabetic Foot Ulcer Wound Care (SC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory Fitness (VO₂peak)
Change in VO₂peak measured using arm ergometry with validated protocols designed for patients with lower extremity limitations. VO₂peak is a key indicator of cardiovascular fitness, with improvements expected in response to the structured exercise interventions.
Measured: Baseline and at 12 weeks
Secondary outcomes (4)
Wound Healing - Percent Wound Area Reduction
Reduction in wound area measured using digital planimetry. This quantifies improvement in wound healing by comparing wound sizes at different time point
Measured: 4, 8, and 12 weeks
Wound Healing - Time to Wound Closure
The duration in days from the start of the intervention until complete wound closure, determined through weekly assessments performed by the clinical team.
Measured: Recorded weekly during the 12-week intervention
Wound Healing - Wound Recurrence Title
Incidence of DFU recurrence in patients whose wounds have closed, providing an indicator of sustained wound healing.
Measured: At 6-month follow-up
Metabolic Control - HbA1c Levels
Glycated hemoglobin concentration measured from blood samples to assess long-term glycemic control, which is crucial for wound healing in DFU patients.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start22 Apr 2025 (estimated)
- Primary completion23 Apr 2027 (estimated)
- Study completion23 Apr 2027 (estimated)
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al Hayah University In Cairo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916663
- Sponsor's protocol ID
- DFU-EX2025-01
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- 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 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Three-Arm, Assessor-Blinded Randomized Controlled Trial Comparing Upper Body Exercise, Combined Non-Weight Bearing Exercise, and Standard Care for Improving Cardiorespiratory Fitness and Supporting Wound Healing in Patients Undergoing Active Diabetic Foot Ulcer Treatment
- ClinicalTrials.gov ID
- NCT06916663
- Acronym / sponsor ID
- DFU-EX2025-01
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- Al Hayah University In CairoUniversity, hospital or other
- Study start
- 22 Apr 2025 (estimated)
- Primary completion
- 23 Apr 2027 (estimated)
- Study completion
- 23 Apr 2027 (estimated)
- First posted
- 8 Apr 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 (RCT) aims to evaluate the effectiveness of two different structured exercise interventions compared to standard care during active diabetic foot ulcer (DFU) treatment. Participants will be allocated to one of three groups: Upper Body Exercise (UBE), Combined Exercise (CE), or Standard Care Control (SC). The interventions are designed to improve cardiorespiratory fitness-as measured by changes in VO₂peak-and other secondary clinical, metabolic, vascular, inflammatory, muscular, and quality-of-life outcomes while ensuring proper offloading and wound management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Upper Body Exercise Group (UBE): | Experimental | Behavioral: Upper Body Exercise Protocol (UBE)Structured upper extremity and core exercise sessions while maintaining foot offloading. |
| Combined Exercise Group (CE): | Experimental | Behavioral: Combined Non-Weight Bearing Exercise Protocol (CE)Structured non-weight bearing combined exercise including upper body, core, and modified lower extremity exercises while maintaining foot offloading. |
| Standard Care Control Group (SC): | Active comparator | Behavioral: Standard Diabetic Foot Ulcer Wound Care (SC)Standard wound care without a structured exercise intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: Adults aged 18 years or older. Diagnosis: Confirmed diagnosis of Type 1 or Type 2 diabetes. Active DFU: Presence of a diabetic foot ulcer under active treatment, as documented by the wound care team.
- Wound Stability: Ulcer size that meets protocol criteria (e.g., <2 cm² or ≥2 cm²) and without critical limb ischemia.
- Ability to Exercise: Medical clearance from a physician to safely participate in unsupervised upper body and non-weight bearing exercises.
- Compliance: Capacity and willingness to adhere to the study protocol, including scheduled exercise sessions and offloading procedures.
- Glycemic Control: Stable glycemic control medications regimen for at least 4 weeks prior to enrollment.
Key exclusion criteria (6 listed)
- Critical DFU Complications: Ulcers with signs of critical limb ischemia, severe infection (e.g., osteomyelitis), or wound deterioration that contraindicates participation.
- Cardiovascular Limitations: Unstable cardiac conditions (e.g., uncontrolled arrhythmias, recent myocardial infarction within 6 months), severe heart failure, or any other condition contraindicating exercise.
- Neurological or Musculoskeletal Limitations: Conditions that significantly impair upper body or core exercise performance (e.g., severe arthritis, recent upper body injury).
- Cognitive Impairment: Significant cognitive or psychiatric disorders that would limit the ability to provide informed consent or adhere to the intervention protocol.
- Concurrent Participation: Enrollment in another clinical trial or exercise program that conflicts with the study protocol.
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 |
|---|---|---|
| Upper Body Exercise Protocol (UBE)Participants randomized to the Upper Body Exercise Group will perform a structured, supervised exercise regimen focused exclusively on the upper extremities and core muscles, while rigorously maintaining foot offloading prescribed for diabetic foot ulcers (DFU). This intervention is delivered face-to-face in hospital-based outpatient rehabilitation centers. Sessions are held three times per week for 12 consecutive weeks (total 36 sessions), with each session lasting 45-60 minutes. Each UBE session comprises a 10-minute warm-up on an arm ergometer at 40-50% of the participant's heart rate reserve (HRR), followed by a circuit of eight upper body and core exercises. | Behavioural | Upper Body Exercise Group (UBE): |
| Combined Non-Weight Bearing Exercise Protocol (CE)Participants in the Combined Exercise Group will engage in a structured exercise regimen that integrates upper body, core, and modified lower extremity exercises-all performed in a non-weight bearing or seated position to ensure complete offloading of the affected foot. Sessions are conducted face-to-face in hospital-based rehabilitation centers. Participants attend three sessions per week for 12 weeks (36 sessions total), each lasting 45-60 minutes. Each session begins with a 10-minute warm-up on an arm ergometer at 40-50% HRR. | Behavioural | Combined Exercise Group (CE): |
| Standard Diabetic Foot Ulcer Wound Care (SC)Participants assigned to the Standard Care Control Group will receive comprehensive DFU wound management in accordance with International Working Group on the Diabetic Foot (IWGDF) guidelines. This includes standard offloading strategies (using Total Contact Cast or removable cast walker), regular weekly wound assessments, and debridement if necessary. Diabetes management education is provided along with routine adjustments and monitoring of the offloading device to ensure proper healing support. No structured exercise intervention is added; however, all aspects of care such as continuous glucose monitoring and vascular assessments will be uniformly applied to allow comparison with the exercise groups. | Behavioural | Standard Care Control Group (SC): |
Primary outcome
Cardiorespiratory Fitness (VO₂peak)
Time frame: Baseline and at 12 weeks
Change in VO₂peak measured using arm ergometry with validated protocols designed for patients with lower extremity limitations. VO₂peak is a key indicator of cardiovascular fitness, with improvements expected in response to the structured exercise interventions.
4 secondary outcomes
Wound Healing - Percent Wound Area Reduction
Time frame: 4, 8, and 12 weeks
Wound Healing - Time to Wound Closure
Time frame: Recorded weekly during the 12-week intervention
Wound Healing - Wound Recurrence Title
Time frame: At 6-month follow-up
Metabolic Control - HbA1c Levels
Time frame: Baseline and 12 weeks
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 8 Apr 2025.
- 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.
Mohamed ElMeligie, Ph.D contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper Body Exercise Protocol (UBE), Combined Non-Weight Bearing Exercise Protocol (CE) and Standard Diabetic Foot Ulcer Wound Care (SC) in people with Diabetic Foot Ulcer, run by Al Hayah University In Cairo at 1 site in Egypt.
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 6 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: looking for participants now, as of the sponsor's last update on 8 Apr 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 Egypt. 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?
Contact Ibrahim Zoheiry, Ph.D (01277774949, ibrahim.alzoheiry@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory Fitness (VO₂peak) (time frame: Baseline and at 12 weeks). 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 8 Apr 2025; AzTrials last refreshed its copy on 27 Oct 2026.