Improving healing of diabetic foot ulcers with a wheeled knee walker
Wheeling to Healing: Does Wheeled Knee Walker Use Improve Wound Healing, Improve Quality of Life and Decrease Risk of Contralateral Ulceration in People With Diabetic Foot Ulcers
This study is testing if using a wheeled knee walker can help people with diabetic foot ulcers heal better than just using regular walking aids.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Saskatchewan Academic / other |
| Locations | 1 site (Saskatoon, Saskatchewan) |
| Trial ID | NCT04257565 on ClinicalTrials.gov |
What this trial studies
This research investigates the effectiveness of a wheeled knee walker (WKW) in improving healing outcomes for patients with diabetic foot ulcers (DFU). Participants will be recruited from a vascular surgery clinic and will be randomly assigned to receive either the WKW or usual care. The study will measure clinical outcomes, quality of life, and physical function at baseline, 6 weeks, and 12 weeks. The goal is to determine if the WKW can enhance healing and reduce the risk of complications compared to traditional walking aids.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a neuropathic plantar DFU who are currently under physician care.
Not a fit: Patients with severe uncontrolled medical conditions or those who are wheelchair dependent prior to ulcer formation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve healing rates and quality of life for patients with diabetic foot ulcers.
How similar studies have performed: While the use of wheeled knee walkers is relatively novel in this context, similar studies on offloading devices have shown promising results in improving healing outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 18 years old * currently under physician care for a DFU of one foot * willing and able to sign informed consent * cognitively functional * have access to a telephone * weigh no more than 300lbs as this is the weight limitation of the wheeled knee walker * have at least one palpable foot pulse * have a neuropathic plantar DFU corresponding to grade 1A (superficial, not extending to tendon, capsule, or bone) using the University of Texas Diabetic Foot Wound Classification System Exclusion Criteria: * coronary or cerebrovascular disease events within the past six months * uncontrolled, severe medical conditions that place the subject at high risk for adverse events, including but not limited to severe congestive heart failure, angina pectoris, obstructive pulmonary disease * uncontrolled neurologic or psychiatric disorders * active infection * significant ulcers or infections of both lower limbs * those who have been wheelchair dependent prior to ulcer formation * absence of pedal pulse * any condition that would limit the ability to ambulate or stand without pain or discomfort, including but not limited to shortness of breath, fatigue, angina, severe arthritis * medication use that causes impaired balance or judgment * other circumstances at the investigators' and primary care providers' discretion.
Where this trial is running
Saskatoon, Saskatchewan
- University of Saskatchewan — Saskatoon, Saskatchewan, Canada (Recruiting)
Study contacts
- Principal investigator: Audrey R Zucker-Levin, PhD — University of Saskatchewan
- Study coordinator: Audrey R Zucker-Levin, PhD
- Email: audrey.zuckerlevin@usask.ca
- Phone: 306-966-7838
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.