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

NCT ID: NCT06916663

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-22
• Study Completion Date: 2027-04-23

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.

Conditions

Diabetic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Upper Body Exercise Group (UBE):

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

Group Type: EXPERIMENTAL

Upper Body Exercise Protocol (UBE)

Intervention Type: BEHAVIORAL

Participants randomized to the Upper Body Exercise Group will perform a structured, supervised exercise regimen focused exclusively on the upper extremities and core muscles, while rigorously maintaining foot offloading prescribed for diabetic foot ulcers (DFU). This intervention is delivered face-to-face in hospital-based outpatient rehabilitation centers. Sessions are held three times per week for 12 consecutive weeks (total 36 sessions), with each session lasting 45-60 minutes.

Each UBE session comprises a 10-minute warm-up on an arm ergometer at 40-50% of the participant's heart rate reserve (HRR), followed by a circuit of eight upper body and core exercises.

Combined Exercise Group (CE):

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

Group Type: EXPERIMENTAL

Combined Non-Weight Bearing Exercise Protocol (CE)

Intervention Type: BEHAVIORAL

Participants in the Combined Exercise Group will engage in a structured exercise regimen that integrates upper body, core, and modified lower extremity exercises-all performed in a non-weight bearing or seated position to ensure complete offloading of the affected foot. Sessions are conducted face-to-face in hospital-based rehabilitation centers. Participants attend three sessions per week for 12 weeks (36 sessions total), each lasting 45-60 minutes.

Each session begins with a 10-minute warm-up on an arm ergometer at 40-50% HRR.

Standard Care Control Group (SC):

Standard wound care without a structured exercise intervention.

Group Type: ACTIVE_COMPARATOR

Standard Diabetic Foot Ulcer Wound Care (SC)

Intervention Type: BEHAVIORAL

Participants assigned to the Standard Care Control Group will receive comprehensive DFU wound management in accordance with International Working Group on the Diabetic Foot (IWGDF) guidelines. This includes standard offloading strategies (using Total Contact Cast or removable cast walker), regular weekly wound assessments, and debridement if necessary. Diabetes management education is provided along with routine adjustments and monitoring of the offloading device to ensure proper healing support. No structured exercise intervention is added; however, all aspects of care such as continuous glucose monitoring and vascular assessments will be uniformly applied to allow comparison with the exercise groups.

Interventions

Upper Body Exercise Protocol (UBE)

Participants randomized to the Upper Body Exercise Group will perform a structured, supervised exercise regimen focused exclusively on the upper extremities and core muscles, while rigorously maintaining foot offloading prescribed for diabetic foot ulcers (DFU). This intervention is delivered face-to-face in hospital-based outpatient rehabilitation centers. Sessions are held three times per week for 12 consecutive weeks (total 36 sessions), with each session lasting 45-60 minutes.

Each UBE session comprises a 10-minute warm-up on an arm ergometer at 40-50% of the participant's heart rate reserve (HRR), followed by a circuit of eight upper body and core exercises.

Intervention Type: BEHAVIORAL

Combined Non-Weight Bearing Exercise Protocol (CE)

Participants in the Combined Exercise Group will engage in a structured exercise regimen that integrates upper body, core, and modified lower extremity exercises-all performed in a non-weight bearing or seated position to ensure complete offloading of the affected foot. Sessions are conducted face-to-face in hospital-based rehabilitation centers. Participants attend three sessions per week for 12 weeks (36 sessions total), each lasting 45-60 minutes.

Each session begins with a 10-minute warm-up on an arm ergometer at 40-50% HRR.

Intervention Type: BEHAVIORAL

Standard Diabetic Foot Ulcer Wound Care (SC)

Participants assigned to the Standard Care Control Group will receive comprehensive DFU wound management in accordance with International Working Group on the Diabetic Foot (IWGDF) guidelines. This includes standard offloading strategies (using Total Contact Cast or removable cast walker), regular weekly wound assessments, and debridement if necessary. Diabetes management education is provided along with routine adjustments and monitoring of the offloading device to ensure proper healing support. No structured exercise intervention is added; however, all aspects of care such as continuous glucose monitoring and vascular assessments will be uniformly applied to allow comparison with the exercise groups.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al Hayah University In Cairo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Faculty of Physical Therapy, Al Hayah University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ibrahim Zoheiry, Ph.D

Role: CONTACT

ibrahim.alzoheiry@hotmail.com

01277774949

Mohamed ElMeligie, Ph.D

Role: CONTACT

mohamed.elmeligie@ahuc.edu.eg

Facility Contacts

Mohamed ElMeligie, Ph.D

Role: primary

mohamed.elmeligie@ahuc.edu.eg

01159880001 ext. +20

Other Identifiers

DFU-EX2025-01

Identifier Type: -

Identifier Source: org_study_id