Diabetes MellitusNCT04257565
Wheeling to Healing: A Novel Method for Improving Healing of Diabetic Foot Ulceration
A study testing Wheeled Knee Walker and Usual and Customary Care in people with Diabetes Mellitus, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The increasing incidence of diabetes and high risk of amputation makes prevention and successful treatment of DFU of vital importance. A relatively new device, the wheeled knee walker, allows total offloading of the affected foot and, when compared to traditional walking aids such as crutches and walkers, requires… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Wheeled Knee Walker and Usual and Customary Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2022to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Saskatchewan
Saskatoon, Saskatchewan, S7N2Z4
Audrey R Zucker-Levin, PhD, 306-966-7838 ext. 306-966-7838, audrey.zuckerlevin@usask.ca
A. Gary Linassi, BMedSc MB
About this study
Official title: 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
The increasing incidence of diabetes and high risk of amputation makes prevention and successful treatment of DFU of vital importance. A relatively new device, the wheeled knee walker, allows total offloading of the affected foot and, when compared to traditional walking aids such as crutches and walkers, requires significantly less physical exertion, is easier to use, and affords more stability. Its potential benefit to improve wound healing, impact physical function and quality of life in people with DFU is not yet known. Therefore, the goal of this research is to determine whether providing a wheeled knee walker to people with diabetic foot ulcers improves clinical outcomes and quality of life when compared to usual and customary care.
Read the detailed description
The rate of diabetes in Saskatchewan is among the highest of all Canadian provinces with a prevalence of 8.5% in 2015 with an expected rise to 11.1% in 2025. Diabetic foot ulcers (DFU) are a common complication and the leading cause of lower limb amputation worldwide. Treatment for DFU include casts, braces, crutches and walkers to remove pressure (offload) from the ulcer. These interventions, when not rejected, foster a sedentary lifestyle which negatively impacts function and quality of life. Also, crutches and walkers may increase risk of ulceration of the sound foot as the arms are often not strong enough to support the body weight when stepping.
The wheeled knee walkers (WKW) is a relatively new walking aid that allows total offloading of one foot, requires less physical exertion, and is more stable than crutches or walkers. The purpose of this research is to determine if a WKW would improve wound healing, quality of life, and physical function while decreasing the risk of sound foot ulceration in people with DFU. To explore these objectives we will recruit people with DFU who are under the care of a vascular surgeon, perform standardized baseline measures for each objective, provide a WKW to half of the participants and then re-evaluate all objectives at 6 and 12 weeks. The results will help guide treatment and inform decision making to optimize care. Further, the project will establish an interdisciplinary collaborative research program for future projects to improve health and advance knowledge.
- Conditions
- Diabetes Mellitus
- Being tested
- Wheeled Knee Walker, Usual and Customary Care
- Keywords
- Foot Ulcer
- Medical subject headings
- Diabetes Mellitus, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheeled Knee WalkerDevice
The Wheeled Knee Walker allows total offloading of a healing limb and may diminish excessive force on the contralateral limb.
Usual and Customary CareOther
This group will receive usual and customary care for treatment of their diabetic foot ulcer
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The Control Group will receive usual and customary care from their vascular specialist. Receives: Other: Usual and Customary Care |
| Intervention Group | Experimental | 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. Receives: Device: Wheeled Knee Walker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing
The wound will be measured using Image J, open source digital imaging software developed at the National Institutes of Health (NIH) to measure wound area of the target wound, in mm2 (the largest foot wound if multiple wounds are present). Image J software has been used specifically for the measurement of diabetic foot ulcers with very high inter- and intra-rater reliability (p=0.997 and 0.999 respectively) [1]. The wound will be traced on acetate paper using a fine permanent marker for use in Image J and a standard distance photograph of the wound will be taken to document wound bed characteristics after physician debridement to healthy granulating tissue or healthy bleeding tissue is reached [1, 2]. The physician will record depth at its greatest point using a probe at the time of debridement, assess wound condition (improving, stable, or deteriorating), and the presence or absence of undermining or tunneling. A completely healed wound has complete epithelialization.
Measured: 12 Weeks
Secondary outcomes (3)
Quality of Life: The Diabetic Foot Ulcer Scale (DFS)
The Diabetic Foot Ulcer Scale (DFS) is a specific instrument designed to assess the impact of foot ulcers and their treatment on quality of life in people with Diabetes [3]. The DFS consists of 58 items grouped into 11 domains: leisure, physical health, daily activities, emotions, noncompliance, family, friends, positive attitude, treatment, satisfaction, and financial. The DFS has good internal consistency with adequate test-retest reliability and sensitivity to change in wound status over time indicating its appropriateness for use in clinical trials. DFS Items are scored by the individual using a five item (1-5) scale with higher scores indicating better quality of life. Score will be measured as an aggregate of all 58 items and individually in all 11 domains: Leisure, Physical health, Daily activities, Emotions, Noncompliance, Family, Friends, Treatment, Satisfaction, Positive Attitude, Financial.
Measured: 12 weeks
Risk of ulceration of the sound foot
Risk of ulceration of the sound foot by measuring in-shoe foot force under the sound foot using a LoadSol® Insole (Novel Electronics Inc, St. Paul, MN) while the participant wears their 'usual' footwear. A 0.5 mm thick LoadSol® Insole corresponding to the participants shoe size will be placed between the sock and shoe of the sound foot prior to performing the 2-Minute Walk Test. The embedded grid of contact cells records the normal force between the plantar side of the foot and the shoe during activity. Foot force, in Newtons, will be measured during one minute of footfalls collected from 30 to 90 seconds of the 2-Minute Walk Test.
Measured: 12 weeks
Physical Function
Physical function will be assessed by measuring distance walked (meters) in 2 minutes with Wheeled Knee Walker or Customary device. The 2-Minute Walk Test is a standardized and reliable clinically applicable method for quantifying physical function across and array of health conditions [4-6]. This test is safe in people with peripheral vascular diseases and heart disorders both of which can be precursors to DFU. It has also been proven to be reliable (intraclass coefficient = 0.94) for people with amputation due to diabetes [7]. Participants will be asked to walk in an unobstructed vacant hallway and to cover as much distance as safely possible in two minutes. The participant will wear their prescribed unloading protective footwear and use any prescribed assistive device for testing. They will be followed with a wheelchair in case rest is needed. The distance walked in two minutes will be measured and recorded using a distance measuring wheel.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 May 2022
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation
- Responsible party
- Principal investigator, Audrey Zucker-Levin, University of Saskatchewan
- Investigators
- Audrey R Zucker-Levin, PhD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257565
- Sponsor's protocol ID
- Bio1469
- Status last verified
- May 2024
- First submitted
- 31 Jan 2020
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jeffcoate WJ, Musgrove AJ, Lincoln NB. Using image J to document healing in ulcers of the foot in diabetes. Int Wound J. 2017 Dec;14(6):1137-1139. doi: 10.1111/iwj.12769. Epub 2017 Jun 13.
PubMed 28612500Veves A, Murray HJ, Young MJ, Boulton AJ. The risk of foot ulceration in diabetic patients with high foot pressure: a prospective study. Diabetologia. 1992 Jul;35(7):660-3. doi: 10.1007/BF00400259.
PubMed 1644245Bohannon RW. Normative reference values for the two-minute walk test derived by meta-analysis. J Phys Ther Sci. 2017 Dec;29(12):2224-2227. doi: 10.1589/jpts.29.2224. Epub 2017 Dec 13.
PubMed 29643611Reid L, Thomson P, Besemann M, Dudek N. Going places: Does the two-minute walk test predict the six-minute walk test in lower extremity amputees? J Rehabil Med. 2015 Mar;47(3):256-61. doi: 10.2340/16501977-1916.
PubMed 25588644Brooks D, Hunter JP, Parsons J, Livsey E, Quirt J, Devlin M. Reliability of the two-minute walk test in individuals with transtibial amputation. Arch Phys Med Rehabil. 2002 Nov;83(11):1562-5. doi: 10.1053/apmr.2002.34600.
PubMed 12422326Lin SJ, Bose NH. Six-minute walk test in persons with transtibial amputation. Arch Phys Med Rehabil. 2008 Dec;89(12):2354-9. doi: 10.1016/j.apmr.2008.05.021. Epub 2008 Nov 1.
PubMed 18976979
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04257565
- Acronym / sponsor ID
- Bio1469
- Conditions
- Diabetes Mellitus
- Keywords
- Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The increasing incidence of diabetes and high risk of amputation makes prevention and successful treatment of DFU of vital importance. A relatively new device, the wheeled knee walker, allows total offloading of the affected foot and, when compared to traditional walking aids such as crutches and walkers, requires significantly less physical exertion, is easier to use, and affords more stability. Its potential benefit to improve wound healing, impact physical function and quality of life in people with DFU is not yet known. Therefore, the goal of this research is to determine whether providing a wheeled knee walker to people with diabetic foot ulcers improves clinical outcomes and quality of life when compared to usual and customary care.
Detailed description
The rate of diabetes in Saskatchewan is among the highest of all Canadian provinces with a prevalence of 8.5% in 2015 with an expected rise to 11.1% in 2025. Diabetic foot ulcers (DFU) are a common complication and the leading cause of lower limb amputation worldwide. Treatment for DFU include casts, braces, crutches and walkers to remove pressure (offload) from the ulcer. These interventions, when not rejected, foster a sedentary lifestyle which negatively impacts function and quality of life. Also, crutches and walkers may increase risk of ulceration of the sound foot as the arms are often not strong enough to support the body weight when stepping.
The wheeled knee walkers (WKW) is a relatively new walking aid that allows total offloading of one foot, requires less physical exertion, and is more stable than crutches or walkers. The purpose of this research is to determine if a WKW would improve wound healing, quality of life, and physical function while decreasing the risk of sound foot ulceration in people with DFU. To explore these objectives we will recruit people with DFU who are under the care of a vascular surgeon, perform standardized baseline measures for each objective, provide a WKW to half of the participants and then re-evaluate all objectives at 6 and 12 weeks. The results will help guide treatment and inform decision making to optimize care. Further, the project will establish an interdisciplinary collaborative research program for future projects to improve health and advance knowledge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Usual and Customary CareThe Control Group will receive usual and customary care from their vascular specialist. |
| Intervention Group | Experimental | Device: Wheeled Knee WalkerThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wheeled Knee WalkerThe Wheeled Knee Walker allows total offloading of a healing limb and may diminish excessive force on the contralateral limb. | Device | Intervention Group |
| Usual and Customary CareThis group will receive usual and customary care for treatment of their diabetic foot ulcer | Other | Control group |
Primary outcome
Wound Healing
Time frame: 12 Weeks
The wound will be measured using Image J, open source digital imaging software developed at the National Institutes of Health (NIH) to measure wound area of the target wound, in mm2 (the largest foot wound if multiple wounds are present). Image J software has been used specifically for the measurement of diabetic foot ulcers with very high inter- and intra-rater reliability (p=0.997 and 0.999 respectively) [1]. The wound will be traced on acetate paper using a fine permanent marker for use in Image J and a standard distance photograph of the wound will be taken to document wound bed characteristics after physician debridement to healthy granulating tissue or healthy bleeding tissue is reached [1, 2]. The physician will record depth at its greatest point using a probe at the time of debridement, assess wound condition (improving, stable, or deteriorating), and the presence or absence of undermining or tunneling. A completely healed wound has complete epithelialization.
3 secondary outcomes
Quality of Life: The Diabetic Foot Ulcer Scale (DFS)
Time frame: 12 weeks
Risk of ulceration of the sound foot
Time frame: 12 weeks
Physical Function
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Background: PubMed 28612500Jeffcoate WJ, Musgrove AJ, Lincoln NB. Using image J to document healing in ulcers of the foot in diabetes. Int Wound J. 2017 Dec;14(6):1137-1139. doi: 10.1111/iwj.12769. Epub 2017 Jun 13.
- Background: PubMed 1644245Veves A, Murray HJ, Young MJ, Boulton AJ. The risk of foot ulceration in diabetic patients with high foot pressure: a prospective study. Diabetologia. 1992 Jul;35(7):660-3. doi: 10.1007/BF00400259.
- Background: PubMed 29643611Bohannon RW. Normative reference values for the two-minute walk test derived by meta-analysis. J Phys Ther Sci. 2017 Dec;29(12):2224-2227. doi: 10.1589/jpts.29.2224. Epub 2017 Dec 13.
- Background: PubMed 25588644Reid L, Thomson P, Besemann M, Dudek N. Going places: Does the two-minute walk test predict the six-minute walk test in lower extremity amputees? J Rehabil Med. 2015 Mar;47(3):256-61. doi: 10.2340/16501977-1916.
- Background: PubMed 12422326Brooks D, Hunter JP, Parsons J, Livsey E, Quirt J, Devlin M. Reliability of the two-minute walk test in individuals with transtibial amputation. Arch Phys Med Rehabil. 2002 Nov;83(11):1562-5. doi: 10.1053/apmr.2002.34600.
- Background: PubMed 18976979Lin SJ, Bose NH. Six-minute walk test in persons with transtibial amputation. Arch Phys Med Rehabil. 2008 Dec;89(12):2354-9. doi: 10.1016/j.apmr.2008.05.021. Epub 2008 Nov 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audrey R Zucker-Levin, PhD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wheeled Knee Walker and Usual and Customary Care in people with Diabetes Mellitus, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Audrey R Zucker-Levin, PhD (306-966-7838, audrey.zuckerlevin@usask.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Healing (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04257565, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.