RCT Comparing Upper Body vs. Combined Exercise Protocols During Active Diabetic Foot Ulcer Treatment

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).