Recruiting

Diabetic Foot Ulceration

Sponsor:

University of Saskatchewan

Code:

NCT04257565

Conditions

Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Wheeled Knee Walker

Usual and Customary Care

Study Details

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.

Conditions

Diabetes Mellitus

Study ID

NCT04257565

Start date

May 1, 2022

Status verified date

May, 2024

Completion date

Sep 30, 2025

Anticipated

Primary completion date

Mar 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control group

The Control Group will receive usual and customary care from their vascular specialist.

experimental: Intervention Group

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.

Interventions

Wheeled Knee Walker

The Wheeled Knee Walker allows total offloading of a healing limb and may diminish excessive force on the contralateral limb.

Usual and Customary Care

This group will receive usual and customary care for treatment of their diabetic foot ulcer

Primary outcome measure

  • Wound Healing [ Time Frame: 12 Weeks ]

Central Contacts and Locations

Central contacts

Audrey R Zucker-Levin, PhD

306-966-7838audrey.zuckerlevin@usask.ca

Locations

University of Saskatchewan

Recruiting

Saskatoon, Saskatchewan, Canada, S7N2Z4

Contacts

Audrey R Zucker-Levin, PhD

306-966-7838audrey.zuckerlevin@usask.ca

More Information

Sponsor

University of Saskatchewan

Last update posted

May 9, 2024

Last verified

May, 2024

Keywords

  • Foot Ulcer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Saskatchewan on 2024-05-09.