RCT Comparing Upper Body vs. Combined Exercise Protocols During Active Diabetic Foot Ulcer
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
| Condition(s) | Diabetic Foot Ulcer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. 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. |
| Who can participate | 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 Crite |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | Al Hayah University In Cairo |
| Locations | Cairo, Egypt |
| Start date | 2025-04-22 |
| NCT ID | NCT06916663 |
| Official listing | https://clinicaltrials.gov/study/NCT06916663 |