Comparing exercise types during treatment of diabetic foot ulcers
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
NA · Al Hayah University In Cairo · NCT06916663
This study is testing whether two types of exercise can help people with diabetic foot ulcers recover better than just standard care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 153 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Al Hayah University In Cairo (other) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06916663 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial evaluates the effectiveness of two structured exercise interventions—Upper Body Exercise (UBE) and Combined Exercise (CE)—against standard care for patients with active diabetic foot ulcers (DFU). Participants will be assigned to one of three groups to assess improvements in cardiorespiratory fitness, as well as various clinical and quality-of-life outcomes while ensuring proper wound management. The study aims to determine if these exercise protocols can enhance recovery during DFU treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with Type 1 or Type 2 diabetes and an active diabetic foot ulcer under treatment.
Not a fit: Patients with critical complications related to diabetic foot ulcers or those unable to exercise safely may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve recovery outcomes for patients with diabetic foot ulcers through enhanced exercise protocols.
How similar studies have performed: Other studies have shown positive outcomes with exercise interventions in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Where this trial is running
Cairo
- Faculty of Physical Therapy, Al Hayah University — Cairo, Egypt (RECRUITING)
Study contacts
- Study coordinator: Ibrahim Zoheiry, Ph.D
- Email: ibrahim.alzoheiry@hotmail.com
- Phone: 01277774949
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetic Foot Ulcer