• Registered Nurses' Association of Ontario (RNAO). Reducing foot complications for people with diabetes. Guideline supplement. Toronto (ON): Registered Nurses' Association of Ontario (RNAO); 2007. 7 p. [109 references]



• Registered Nurses' Association of Ontario (RNAO). Reducing foot complications for people with diabetes. Toronto (ON): Registered Nurses' Association of Ontario (RNAO); 2004 Mar. 80 p. [63 references]

This is the current release of the guideline.

Diabetic foot complications including foot ulceration and/or amputation

Counseling
Management
Prevention
Risk Assessment

Endocrinology
Family Practice
Internal Medicine
Nursing
Orthopedic Surgery
Physical Medicine and Rehabilitation
Podiatry

Advanced Practice Nurses
Nurses

• To review the March 2004 Nursing Best Practice Guidelines for Reducing Foot Complications for People with Diabetes in light of new evidence obtained since the originally published guidelines
• To support nurses as they help people with diabetes reduce their risk of foot complications. Specifically, this guideline assists nurses who are not specialists in diabetes care to:
  • Conduct a risk assessment for foot ulcers
  • Provide basic education for prevention of foot ulcers for all clients with diabetes
  • Implement appropriate interventions when clients are assessed as higher risk for foot ulcers and/or amputations

Adults with diabetes who are at risk for developing foot complications

Risk Assessment/Prevention

1. Annual foot examinations
2. Assessment of risk factors, including history of previous foot ulcers, sensation, structural and biomechanical abnormalities, circulation, and self-care and knowledge
3. Risk classification

Management/Counseling

Patient education

Incidence of foot ulceration and amputation

Searches of Electronic Databases
Searches of Unpublished Data

March 2004 Guideline

Five guidelines were selected as foundation documents for this guideline.

2007 Supplement

Two additional guidelines and 95 studies were identified for review.

Weighting According to a Rating Scheme (Scheme Given)

Levels of Evidence

Level Ia: Evidence obtained from meta-analysis of randomized controlled trials, plus consensus

Level Ib: Evidence obtained from at least one randomized controlled trial, plus consensus

Level II: Evidence obtained from at least one well-designed controlled study without randomization or evidence obtained from at least one other type of well-designed quasi-experimental study, plus consensus

Level III: Evidence obtained from well-designed nonexperimental descriptive studies, such as comparative studies, correlation studies, and case studies, plus consensus

Level IV: Evidence obtained from expert committee reports of opinions and/or clinical experiences of respected authorities, plus consensus

Systematic Review with Evidence Tables

March 2004 Guideline

Following the initial literature search, members of the development panel critically appraised eight guidelines using the "Appraisal Instrument for Clinical Guidelines" from Cluzeau et al. (1997). This instrument allows for evaluation in three key dimensions: rigour, content and context, and application. From this appraisal process, four documents were identified as high quality, relevant guidelines and were selected as "foundation" documents for this guideline.

Following a second phase of the literature search, a critique of systematic review articles, technical reviews, and other pertinent literature was conducted to update and/or validate recommendations in the existing guidelines.

Expert Consensus

March 2004 Guideline

In February of 2001, a panel of nurses with expertise in diabetes care, education, and research representing institutional, community, and academic settings was convened under the auspices of the Registered Nurses' Association of Ontario (RNAO). The first task of the group was to review existing clinical practice guidelines in order to build on the current understanding of diabetes care and management and to reach consensus on the scope of the guideline.

The first strategy undertaken to develop the recommendations was a review of the literature to identify risk factors for diabetes foot complications that were consistently supported by research studies utilizing strong methodologies. Once the panel identified the risk factors, small task groups were formed to further study each of the risk indicators. The small groups conducted an in-depth search for evidence to validate the risk factors, as well as to identify evidence-based processes for risk assessment. The subgroups further identified assessment tools, mechanisms, and/or educational resources for each of the risk factors. Through an iterative process of discussion and validation, consensus was reached on the final draft recommendations for the guideline.

2007 Supplement

As part of its commitment to ensure consistency with the best available evidence, the Registered Nurses' Association of Ontario (RNAO) has established a monitoring and review process which involves a full review of each guideline every 3 years.

A panel of specialists was assembled for this review, comprised of members from the original development panel as well as other recommended individuals with particular expertise in this practice area. A structured evidence review based on the scope of the original guideline was conducted to capture relevant literature and other guidelines published since the original literature search. Initial findings regarding the impact of the current evidence base on the guideline were developed and circulated to the review panel.

The review panel members were given a mandate to review the original guideline in light of the new evidence, specifically to ensure the validity, appropriateness and safety of the guideline recommendations as published in 2004. In August 2007, the panel was convened for a teleconference to achieve consensus on the impact of this new evidence on the existing recommendations.

After a review of the current evidence, it was the consensus of the panel that no substantive changes to the recommendations were required. However, one revision was made to Appendix D: Diabetes Foot Assessment/Risk Screening Guide based on an error noted in the original publication.

Not applicable

A formal cost analysis was not performed and published cost analyses were not reviewed.

Clinical Validation-Pilot Testing
External Peer Review
Internal Peer Review

March 2004 Guideline

A draft document was submitted to a set of external stakeholders for review and feedback. Stakeholders represented various health care professional groups, clients and families, as well as professional associations. External stakeholders were asked to provide feedback using a questionnaire consisting of open and closed-ended questions. The results were compiled and reviewed by the development panel; discussion and consensus resulted in revisions to the draft document prior to pilot testing.

A pilot implementation practice setting was identified through a "Request for Proposal" (RFP) process. Practice settings in Ontario were asked to submit a proposal if they were interested in pilot testing the recommendations of the guideline. The proposals underwent an external review process and the successful applicant (practice setting) selected. This guideline was implemented by a hospital and a community care organization in northern Ontario between April 2002 and July 2003. Four participating medical/oncology hospital units located at two sites in one community participated, as did the diabetic education and care centre, located at a third site. Nurses participating from the community care organization were located in three geographically separate communities. An evaluation of the implementation process was conducted during this period by an evaluation team that was external to the pilot site.

The development panel reconvened following completion of the pilot to review the experiences of the pilot sites, consider the evaluation results and review any new literature published since the initial development phase. All these sources of information were used to update and revise the document prior to publication.

Note from the National Guideline Clearinghouse (NGC) and the Registered Nurses' Association of Ontario (RNAO): In August 2007, the RNAO reviewed the current practice recommendations for this topic. A review of the most recent studies and relevant guidelines published since the development of the guideline Reducing Foot Complications for People with Diabetes did not support the need for change to the recommendations, but rather suggests stronger evidence for the approach to caring for those with diabetes.

Levels of evidence supporting the recommendations (Level Ia, Ib, II, III, IV) are defined at the end of the "Major Recommendations" field.

Practice Recommendations

Recommendation 1.0

Physical examination of the feet to assess risk factors for foot ulceration/amputation should be performed by a health care professional. (Level of Evidence Ib)

Recommendation 1.1

This examination should be performed at least annually in all people with diabetes over the age of 15 and at more frequent intervals for those at higher risk. (Level of Evidence IV)

Recommendation 2.0

Nurses should conduct a foot risk assessment for clients with known diabetes. This risk assessment includes the following:

• History of previous foot ulcers
• Sensation
• Structural and biomechanical abnormalities
• Circulation
• Self-care behaviour and knowledge

(Level of Evidence IV)

Recommendation 3.0

Based on assessment of risk factors, clients should be classified as "lower" or "higher" risk for foot ulceration/amputation. (Level of Evidence IV)

Recommendation 4.0

All people with diabetes should receive basic foot care education. (Level of Evidence Ib)

Recommendation 4.1

Foot care education should be provided to all clients with diabetes and reinforced at least annually. (Level of Evidence IV)

Recommendation 5.0

Nurses in all practice settings should provide or reinforce basic foot care education, as appropriate. (Level of Evidence IV)

Recommendation 5.1

The basic foot care education for people with diabetes should include the following six elements:

• Awareness of personal risk factors
• Importance of at least annual inspection of feet by a health care professional
• Daily self inspection of feet
• Proper nail and skin care
• Injury prevention
• When to seek help or specialized referral

(Level of Evidence IV)

Recommendation 5.2

Education should be tailored to client's current knowledge, individual needs, and risk factors. Principles of adult learning must be used. (Level of Evidence IV)

Recommendation 6.0

Individuals assessed as being at "higher" risk for foot ulcer/amputation should be advised of their risk status and referred to their primary care provider for additional assessment or to specialized diabetes or foot care treatment and education teams as appropriate. (Level of Evidence IV)

Education Recommendations

Recommendation 7.0

Nurses need knowledge and skills in the following areas in order to competently assess a client´s risk for foot ulcers and provide the required education and referral:

• Skills in conducting an assessment of the five risk factors
• Knowledge and skill in educating clients
• Knowledge of sources of local referral

(Level of Evidence IV)

Recommendation 8.0

Educational institutions should incorporate the Registered Nurses' Association of Ontario (RNAO) Nursing Best Practice Guideline Reducing Foot Complications for People with Diabetes into basic nursing education curriculum as well as provide continuing education programs in this topic area. (Level of Evidence IV)

Organization and Policy Recommendations

Recommendation 9.0

Organizations should develop a policy that acknowledges and designates human and fiscal resources to support nursing's role in assessment, education, and referral of clients for appropriate foot care. It is the organization's responsibility to advocate with policy makers and develop policy that facilitates implementation. (Level of Evidence IV)

Recommendation 10.0

Organizations should ensure that resources for implementation are available to clients and staff. Examples of such resources include policies and procedures, documentation forms, educational materials, referral processes, workload hours, and monofilaments. (Level of Evidence IV)

Recommendation 11.0

Organizations should work with community partners to develop a process to facilitate client referral and access to local diabetes resources and health professionals with specialized knowledge in diabetes foot care. (Level of Evidence IV)

Recommendation 12.0

Organizations are encouraged to establish or identify a multidisciplinary, interagency team comprised of interested and knowledgeable persons to address and monitor quality improvement in diabetes foot complication prevention. (Level of Evidence IV)

Recommendation 13.0

Organizations should consult an infection control team to define appropriate care, maintenance, and replacement of the Semmes-Weinstein monofilament. Such a process may include setting up a protocol for the appropriate maintenance and replacement of the monofilaments. (Level of Evidence IV)

Recommendation 14.0

Organizations should advocate for strategies and funding to assist clients to obtain appropriate footwear and specialized diabetes education. For example, the inclusion of funding support through the Assistive Devices Program (ADP) for appropriate footwear and orthotics. (Level of Evidence IV)

Recommendation 15.0

Organizations should advocate for an increase in the availability and accessibility of diabetes care and education services for all residents of Ontario. (Level of Evidence IV)

Recommendation 16.0

Nursing best practice guidelines can be successfully implemented only where there are adequate planning, resources, organizational and administrative support, as well as appropriate facilitation. Organizations may wish to develop a plan for implementation that includes:

• An assessment of organizational readiness and barriers to education
• Involvement of all members (whether in a direct or indirect supportive function) who will contribute to the implementation process
• Dedication of a qualified individual to provide the support needed for the education and implementation process
• Ongoing opportunities for discussion and education to reinforce the importance of best practices
• Opportunities for reflection on personal and organizational experience in implementing guidelines

(Level of Evidence IV)

Refer to the "Description of the Implementation Strategy" field for more information.

Definitions:

Levels of Evidence

Level Ia: Evidence obtained from meta-analysis of randomized controlled trials, plus consensus

Level Ib: Evidence obtained from at least one randomized controlled trial, plus consensus

Level II: Evidence obtained from at least one well-designed controlled study without randomization or evidence obtained from at least one other type of well-designed quasi-experimental study, plus consensus

Level III: Evidence obtained from well-designed nonexperimental descriptive studies, such as comparative studies, correlation studies, and case studies, plus consensus

Level IV: Evidence obtained from expert committee reports of opinions and/or clinical experiences of respected authorities, plus consensus

An algorithm is provided in the original guideline document for risk assessment.

The type of evidence is provided for each recommendation (see "Major Recommendations").

A program of risk assessment, self-care education, and regular reinforcement of self-care may reduce the incidence of foot ulceration and amputation.

Not stated

• Guidelines should not be applied in a "cookbook" fashion but used as a tool to assist in decision making for individualized client care, as well as ensuring that appropriate structures and supports are in place to provide the best possible care.
• These best practice guidelines are related only to nursing practice and not intended to take into account fiscal efficiencies. These guidelines are not binding for nurses and their use should be flexible to accommodate client/family wishes and local circumstances. They neither constitute a liability nor a discharge from liability. While every effort has been made to ensure the accuracy of the contents at the time of publication, neither the authors nor Registered Nurses' Association of Ontario (RNAO) give any guarantee as to the accuracy of the information contained in them nor accept any liability, with respect to loss, damage, injury or expense arising from any such errors or omission in the contents of this work. Any reference throughout the document to specific pharmaceutical products as examples does not imply endorsement of any of these products.

Best practice guidelines can only be successfully implemented if there are adequate planning, resources, organizational and administrative support, as well as appropriate facilitation. In this light, the Registered Nurses' Association of Ontario (RNAO), through a panel of nurses, researchers, and administrators, has developed a Toolkit: Implementation of Clinical Practice Guidelines based on available evidence, theoretical perspectives, and consensus. The Toolkit is recommended for guiding the implementation of any clinical practice guideline in a healthcare organization.

The Toolkit; provides step-by-step directions to individuals and groups involved in planning, coordinating, and facilitating guideline implementation. Specifically, the Toolkit addresses the following key steps in implementing a guideline:

1. Identifying a well-developed, evidence-based clinical practice guideline
2. Identification, assessment, and engagement of stakeholders
3. Assessment of environmental readiness for guideline implementation
4. Identifying and planning evidence-based implementation strategies
5. Planning and implementing an evaluation
6. Identifying and securing required resources for implementation and evaluation

Implementing practice guidelines that result in successful practice changes and positive clinical impact is a complex undertaking. The Toolkit is one key resource for managing this process.

Living with Illness
Staying Healthy

Effectiveness
Patient-centeredness

• Registered Nurses' Association of Ontario (RNAO). Reducing foot complications for people with diabetes. Guideline supplement. Toronto (ON): Registered Nurses' Association of Ontario (RNAO); 2007. 7 p. [109 references]



• Registered Nurses' Association of Ontario (RNAO). Reducing foot complications for people with diabetes. Toronto (ON): Registered Nurses' Association of Ontario (RNAO); 2004 Mar. 80 p. [63 references]

Not applicable: The guideline was not adapted from another source.

2004 Mar (addendum released 2007)

Registered Nurses' Association of Ontario - Professional Association

Funding was provided by the Ontario Ministry of Health and Long-Term Care.

Not stated

Review Panel Members

Sharon Brez, RN, BScN, MA(Ed), CDE
Review Chair
Advanced Practice Nurse
The Ottawa Endocrine and Diabetes Centre
The Ottawa Hospital
Ottawa, Ontario

Lillian Delmas, RN, BScN, CRRN
Nurse Clinician
Ottawa Hospital Rehabilitation Centre
Ottawa, Ontario

Karen Gorecki, RN, MN, CDE
Clinical Nurse Specialist
Leadership Sinai Centre for Diabetes
Mount Sinai Hospital
Toronto, Ontario

Cherí Ann Hernandez, RN, PhD, CDE
Associate Professor|Faculty of Nursing, University of Windsor
Windsor, Ontario

Robin Hokstad, RN, CDE
Diabetes Nurse Educator
Nipissing Diabetes Resource Centre
North Bay, Ontario

Margaret Hume, RN, MScN, CDE
Clinical Nurse Specialist (retired)
Toronto, Ontario

Sharon Jaspers, RN(EC), PHCNP
Nurse Practitioner
Stroke Prevention Clinic
Thunder Bay Regional Health Sciences Centre
Diabetes Educator
NorWest Community Health Centres
Faculty
Northern Ontario School of Medicine
Thunder Bay, Ontario

Karen Lorimer, RN, MScN, CCHN
Advanced Practice Nurse
Carefor Health & Community Services
Ottawa, Ontario

Alwyn Moyer, RN, MSc(A), PhD
Health Care Consultant
Adjunct Professor
University of Ottawa
Ottawa, Ontario

Samantha Mayo, RN, BScN, MN
Program Coordinator
Nursing Best Practice Guidelines Program
Registered Nurses' Association of Ontario
Toronto, Ontario

The Registered Nurses' Association of Ontario (RNAO) received funding from the Ministry of Health and Long-Term Care (MOHLTC). This guideline was developed by a panel of nurses and researchers convened by the RNAO and conducting its work independent of any bias or influence from the MOHLTC.

This is the current release of the guideline.

None available

This NGC summary was completed by ECRI on September 20, 2004. The information was verified by the guideline developer on October 14, 2004. This NGC summary was updated by ECRI Institute on October 30, 2008. The updated information was verified by the guideline developer on November 14, 2008.

With the exception of those portions of this document for which a specific prohibition or limitation against copying appears, the balance of this document may be produced, reproduced, and published in its entirety only, in any form, including in electronic form, for educational or noncommercial purposes, without requiring the consent or permission of the Registered Nurses' Association of Ontario, provided that an appropriate credit or citation appears in the copied work as follows:

Registered Nurses' Association of Ontario (2007). Reducing foot complications for people with diabetes. (rev. suppl.) Toronto, Canada: Registered Nurses' Association of Ontario.