Status:
RECRUITING
RCT Comparing Upper Body vs. Combined Exercise Protocols During Active Diabetic Foot Ulcer Treatment
Lead Sponsor:
Al Hayah University In Cairo
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 23 2027
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT06916663
Start Date
April 22 2025
End Date
April 23 2027
Last Update
April 8 2025
Active Locations (1)
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1
Faculty of Physical Therapy, Al Hayah University
Cairo, Egypt, 12311