Clinical trial NCT06916663: RCT Comparing Upper Body vs. Combined Exercise Protocols During Active Diabetic Foot Ulcer Treatment
Official title: A Prospective, Three-Arm, Assessor-Blinded Randomized Controlled Trial Comparing Upper Body Exercise, Combined Non-Weight Bearing Exercise, and Standard Care for Improving Cardiorespiratory Fitness and Supporting Wound Healing in Patients Undergoing Active Diabetic Foot Ulcer Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Lead sponsor: Al Hayah University In Cairo
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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).

Primary outcomes:
measure: Cardiorespiratory Fitness (VO₂peak)
timeFrame: Baseline and at 12 weeks
Secondary outcomes:
measure: Wound Healing - Percent Wound Area Reduction
timeFrame: 4, 8, and 12 weeks
measure: Wound Healing - Time to Wound Closure
timeFrame: Recorded weekly during the 12-week intervention
measure: Wound Healing - Wound Recurrence Title
timeFrame: At 6-month follow-up
measure: Metabolic Control - HbA1c Levels
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy, Al Hayah University
Study officials:
References: