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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Behavioral: Upper Body Exercise Protocol (UBE); Behavioral: Combined Non-Weight Bearing Exercise Protocol (CE); Behavioral: Standard Diabetic Foot Ulcer Wound Care (SC)

• Study Type: Interventional
• Enrollment (Estimated): 153
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ibrahim Zoheiry, Ph.D; Phone Number: 01277774949; Email: ibrahim.alzoheiry@hotmail.com
• Study Contact Backup: Name: Mohamed ElMeligie, Ph.D; Email: mohamed.elmeligie@ahuc.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 12311
    • Recruiting
    • Faculty of Physical Therapy, Al Hayah University
    • Contact: Mohamed ElMeligie, Ph.D; Phone Number: +20 01159880001; Email: mohamed.elmeligie@ahuc.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Upper Body Exercise Group (UBE): Structured upper extremity and core exercise sessions while maintaining foot offloading.	Behavioral: 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.
Experimental: Combined Exercise Group (CE): Structured non-weight bearing combined exercise including upper body, core, and modified lower extremity exercises while maintaining foot offloading.	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.
Active Comparator: Standard Care Control Group (SC): Standard wound care without a structured exercise intervention.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiorespiratory Fitness (VO₂peak)	Change in VO₂peak measured using arm ergometry with validated protocols designed for patients with lower extremity limitations. VO₂peak is a key indicator of cardiovascular fitness, with improvements expected in response to the structured exercise interventions.	Baseline and at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Healing - Percent Wound Area Reduction	Reduction in wound area measured using digital planimetry. This quantifies improvement in wound healing by comparing wound sizes at different time point	4, 8, and 12 weeks
Wound Healing - Time to Wound Closure	The duration in days from the start of the intervention until complete wound closure, determined through weekly assessments performed by the clinical team.	Recorded weekly during the 12-week intervention
Wound Healing - Wound Recurrence Title	Incidence of DFU recurrence in patients whose wounds have closed, providing an indicator of sustained wound healing.	At 6-month follow-up
Metabolic Control - HbA1c Levels	Glycated hemoglobin concentration measured from blood samples to assess long-term glycemic control, which is crucial for wound healing in DFU patients.	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: Al Hayah University In Cairo

Study record dates

Study Major Dates

• Study Start (Estimated): April 22, 2025
• Primary Completion (Estimated): April 23, 2027
• Study Completion (Estimated): April 23, 2027

Study Registration Dates

• First Submitted: April 1, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Diseases; Ulcer; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: DFU-EX2025-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No