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

Launched by AL HAYAH UNIVERSITY IN CAIRO · Apr 1, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how different types of exercise can help people with diabetic foot ulcers (DFUs) feel better while they are being treated. There are two exercise groups: one focuses on upper body exercises, and the other includes both upper body and lower body exercises, while a third group will receive standard care without any additional exercise. The goal is to see if these exercise programs can improve overall fitness and health, while also making sure that the ulcers are properly cared for.

To be eligible for this study, participants need to be at least 18 years old and have a confirmed diagnosis of diabetes along with an active foot ulcer that is being treated. They must also be cleared by a doctor to safely do the exercises. Participants will be asked to follow a specific exercise schedule while continuing their usual care for their ulcers. It's important to know that those with certain serious health conditions or complications related to their foot ulcers may not be able to take part in the study. Overall, this trial aims to find out if exercise can make a positive difference in the recovery and quality of life for people dealing with diabetic foot ulcers.

Gender

ALL

Eligibility 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).