Clinical trial NCT04257565: Wheeling to Healing: A Novel Method for Improving Healing of Diabetic Foot Ulceration
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Foot Ulcer
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Saskatchewan Health Research Foundation
First posted: 2020-02-06
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled clinical trial
Primary purpose: TREATMENT

Brief 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 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.

Eligibility 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.

Primary outcomes:
measure: Wound Healing
timeFrame: 12 Weeks
Secondary outcomes:
measure: Quality of Life: The Diabetic Foot Ulcer Scale (DFS)
timeFrame: 12 weeks
measure: Risk of ulceration of the sound foot
timeFrame: 12 weeks
measure: Physical Function
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Audrey R Zucker-Levin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Veves 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.
citation: Bohannon 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.
citation: Reid 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.
citation: Brooks 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.
citation: Lin 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.