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

Al Hayah University In Cairo

Status: Enrolling

Conditions: Diabetic Foot Ulcer

Treatments: Behavioral: Standard Diabetic Foot Ulcer Wound Care (SC); Behavioral: Upper Body Exercise Protocol (UBE); Behavioral: Combined Non-Weight Bearing Exercise Protocol (CE)

Study type: Interventional

Funder types: Other

Identifiers

NCT06916663

DFU-EX2025-01

Details and patient eligibility

About

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.

Enrollment: 153 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

153 participants in 3 patient groups

Upper Body Exercise Group (UBE):

Experimental group

Description:

Structured upper extremity and core exercise sessions while maintaining foot offloading.

Treatment:

Behavioral: Upper Body Exercise Protocol (UBE)

Combined Exercise Group (CE):

Experimental group

Description:

Structured non-weight bearing combined exercise including upper body, core, and modified lower extremity exercises while maintaining foot offloading.

Treatment:

Behavioral: Combined Non-Weight Bearing Exercise Protocol (CE)

Standard Care Control Group (SC):

Active Comparator group

Description:

Standard wound care without a structured exercise intervention.

Treatment:

Behavioral: Standard Diabetic Foot Ulcer Wound Care (SC)