Wheeling to Healing: A Novel Method for Improving Healing of Diabetic Foot Ulceration

NCT04257565 | Recruiting

• 1 other identifier: Bio1469
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Keywords

Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• 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.

  12 Weeks

Secondary Outcomes (3)

• Quality of Life: The Diabetic Foot Ulcer Scale (DFS)

  12 weeks

• Risk of ulceration of the sound foot

  12 weeks

• Physical Function

  12 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

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.

Device: Wheeled Knee Walker

Interventions

Wheeled Knee Walker DEVICE

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

Intervention Group

Usual and Customary Care OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Saskatchewan: lead
• Saskatchewan Health Research Foundation: collaborator

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N2Z4, Canada

RECRUITING

Related Publications (6)

• 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.

  PMID: 28612500 BACKGROUND

• 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.

  PMID: 1644245 BACKGROUND

• 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.

  PMID: 29643611 BACKGROUND

• 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.

  PMID: 25588644 BACKGROUND

• 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.

  PMID: 12422326 BACKGROUND

• 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.

  PMID: 18976979 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Foot Ulcer

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer

Study Officials

• Audrey R Zucker-Levin, PhD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Audrey R Zucker-Levin, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: randomized controlled clinical trial

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 6, 2020
• Study Start: May 1, 2022
• Primary Completion: March 31, 2025
• Study Completion: September 30, 2025
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)