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Mobility Aid
Wheeled Knee Walker for Diabetes
N/A
Recruiting
Led By Audrey R Zucker-Levin, PhD
Research Sponsored by University of Saskatchewan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial will compare the use of a wheeled knee walker to usual and customary care in order to determine whether it improves clinical outcomes and quality of life for people with diabetic foot ulcers.
Who is the study for?
This trial is for individuals with diabetes and a specific type of foot ulcer (grade 1A). Participants must be under a doctor's care, weigh no more than 300lbs, be over 18 years old, mentally capable, have phone access, and at least one palpable foot pulse. Excluded are those with active infections or severe health conditions like heart failure or recent strokes.Check my eligibility
What is being tested?
The study tests if using a wheeled knee walker aids healing in diabetic foot ulcers compared to usual care. It aims to see if this device can improve wound healing and quality of life by allowing total offloading of the affected foot while being easier to use than crutches.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include discomfort from using the device, skin irritation where it contacts the body, or an increased risk of falls if balance is affected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Wound Healing
Secondary outcome measures
Physical Function
Quality of Life: The Diabetic Foot Ulcer Scale (DFS)
Foot
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
The Intervention Group will receive usual and customary care from their vascular specialist and they will be provided and trained to use the wheeled knee walker.
Group II: Control groupActive Control1 Intervention
The Control Group will receive usual and customary care from their vascular specialist.
Find a Location
Who is running the clinical trial?
Saskatchewan Health Research FoundationOTHER
32 Previous Clinical Trials
4,961 Total Patients Enrolled
University of SaskatchewanLead Sponsor
251 Previous Clinical Trials
154,182 Total Patients Enrolled
Audrey R Zucker-Levin, PhDPrincipal InvestigatorUniversity of Saskatchewan
1 Previous Clinical Trials
40 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have experienced a heart or brain-related medical event within the past six months.You have uncontrolled neurological or psychiatric disorders that are not being managed by medication or treatment.You have severe ulcers or infections on both of your lower limbs.Your foot pulse cannot be felt.The investigators and primary care providers may decide to exclude you based on other factors that they think are important.You have normal cognitive function.You have any health condition that makes it difficult for you to walk or stand without experiencing pain or discomfort. This includes conditions like shortness of breath, fatigue, chest pain, and severe arthritis.You were unable to walk without a wheelchair before developing an ulcer.You are taking medication that affects your balance or judgment.You can feel at least one pulse in your foot.You have a minor foot ulcer that does not go too deep and is not infected.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
- Group 2: Control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the projected participant size for this trial?
"Affirmative. According to records hosted on clinicaltrials.gov, this medical experiment was posted initially on May 1st 2022 and is still actively recruiting participants. A total of 68 patients need to be sourced from a single location."
Answered by AI
Is this trial currently accessible to participants?
"Affirmative. As indicated on clinicaltrials.gov, this trial is currently recruiting participants, having originally been published on May 1st 2022 and most recently edited a fortnight later. 68 individuals will be enrolled at one testing site."
Answered by AI
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