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

NCT06916663 | Recruiting

• 1 other identifier: DFU-EX2025-01
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Wound Healing - Percent Wound Area Reduction

  4, 8, and 12 weeks

• Wound Healing - Time to Wound Closure

  Recorded weekly during the 12-week intervention

• Wound Healing - Wound Recurrence Title

  At 6-month follow-up

• Metabolic Control - HbA1c Levels

  Baseline and 12 weeks

Study Arms (3)

Upper Body Exercise Group (UBE):

EXPERIMENTAL

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

Behavioral: Upper Body Exercise Protocol (UBE)

Combined Exercise Group (CE):

EXPERIMENTAL

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)

Standard Care Control Group (SC):

ACTIVE COMPARATOR

Standard wound care without a structured exercise intervention.

Behavioral: Standard Diabetic Foot Ulcer Wound Care (SC)

Interventions

Upper Body Exercise Protocol (UBE) 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.

Upper Body Exercise Group (UBE):

Combined Non-Weight Bearing Exercise Protocol (CE) 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.

Combined Exercise Group (CE):

Standard Diabetic Foot Ulcer Wound Care (SC) 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.

Standard Care Control Group (SC):

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Al Hayah University In Cairo: lead

Study Sites (1)

Faculty of Physical Therapy, Al Hayah University

Cairo, 12311, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Central Study Contacts

Ibrahim Zoheiry, Ph.D

CONTACT

01277774949; ibrahim.alzoheiry@hotmail.com

Mohamed ElMeligie, Ph.D

CONTACT

mohamed.elmeligie@ahuc.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: April 22, 2025
• Primary Completion (Estimated): April 23, 2027
• Study Completion (Estimated): April 23, 2027
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)