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.
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Upper Body Exercise Protocol (UBE)
BehavioralParticipants 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)
BehavioralParticipants 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)
BehavioralParticipants 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.
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.
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
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.
Wound Healing - Wound Recurrence Title
Incidence of DFU recurrence in patients whose wounds have closed, providing an indicator of sustained wound healing.
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.
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