Actively Recruiting
RCT Comparing Upper Body vs. Combined Exercise Protocols During Active Diabetic Foot Ulcer Treatment
Led by Al Hayah University In Cairo · Updated on 2025-04-08
153
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
RCT Comparing Upper Body vs. Combined Exercise Protocols During Active Diabetic Foot Ulcer Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Confirmed diagnosis of Type 1 or Type 2 diabetes
- Presence of an active diabetic foot ulcer under treatment
- Ulcer size meeting protocol criteria and without critical limb ischemia
- Medical clearance to safely participate in upper body and non-weight bearing exercises
- Willingness and ability to follow the study protocol including exercise and offloading
- Stable glycemic control medication regimen for at least 4 weeks prior to enrollment
- Ability to provide written informed consent
You will not qualify if you...
- Ulcers with critical limb ischemia, severe infection, or worsening wounds
- Unstable cardiac conditions or severe heart failure
- Conditions severely limiting upper body or core exercise ability
- Significant cognitive or psychiatric disorders impacting consent or adherence
- Participation in conflicting clinical trials or exercise programs
- Other medical conditions increasing risk during exercise as judged by the study physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Faculty of Physical Therapy, Al Hayah University
Cairo, Egypt, 12311
Actively Recruiting
Research Team
I
Ibrahim Zoheiry, Ph.D
CONTACT
M
Mohamed ElMeligie, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here