Comparing exercise types during treatment of diabetic foot ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial evaluates the effectiveness of two structured exercise interventions—Upper Body Exercise (UBE) and Combined Exercise (CE)—against standard care for patients with active diabetic foot ulcers (DFU). Participants will be assigned to one of three groups to assess improvements in cardiorespiratory fitness, as well as various clinical and quality-of-life outcomes while ensuring proper wound management. The study aims to determine if these exercise protocols can enhance recovery during DFU treatment.

Why it matters

Who can join: the full rules

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).

Where it's running

• Faculty of Physical Therapy, Al Hayah University
  Cairo, Egypt Recruiting

Study contacts

• Study coordinator: Ibrahim Zoheiry, Ph.D
• Email: ibrahim.alzoheiry@hotmail.com
• Phone: 01277774949

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.