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Diabetic Foot Ulcers - Overview

Diabetic Foot Ulcers - Overview

Diabetic Foot Ulcers - Overview

INTRODUCTION 

Background

A diabetic foot ulcer (DFU) can be defined as a full-thickness wound (i.e, involving the subcutaneous tissue) below the ankle, or as a lesion of the foot penetrating through the dermis, in people with type 1 or type 2 diabetes [1][2]. (See Figure 1)

Guidelines, Quality Measures and resources for DFU prevention, assessment and management are listed below. For and introduction and assessment of DFUs including epidemiology, risk factors, etiology, pathophysiology, history, physical examination, diagnosis, differential diagnoses, documentation and ICD-10 coding, see "Diabetic Foot Ulcers - Introduction and Assessment". For DFU management, see "Diabetic Foot Ulcer - Treatment". For DFU prevention, see "Diabetic Foot Ulcer - Prevention".

Figure 1. Diabetic foot ulcer with dry gangrene

Relevance 

  • DFU is the leading cause of lower-extremity amputation and hospitalization.[3] Once lower extremity amputation due to diabetes has occurred, access to care and treatment seem ineffective in preventing death.[4] Mortality rate (5 year, unadjusted) post diabetes-related amputation is 39%, comparable to that of colorectal cancer.[4]

EVIDENCE-BASED CLINICAL GUIDELINES

Below is a list of the some of the most recent evidence-based guidelines on DFU: 

Evidence-based guideline, Year Publishing Organization, Country or Region Links
Diabetic Foot Australia guideline on footwear for people with diabetes, 2018
Australian foot specialists, AustraliaGuideline (free)
Microvascular Complications and Foot Care, 2017
American Diabetes Association, USA
Guideline (free)
WHS guidelines update: Diabetic foot ulcer treatment
Wound Healing Society, USA
Guideline (free)
IWGDF guidance on the diagnosis, prognosis and management of peripheral artery disease inpatients with foot ulcers in diabetes, 2016
InternationalWorking Group on the DiabeticFoot (IWGDF)
Guideline (free)
IWGDF guidance on the prevention of foot ulcers in at-risk patients with diabetes, 2016
InternationalWorking Group on the DiabeticFoot (IWGDF)
Guideline (free)
IWGDF guidance on use of interventions to enhance the healing of chronic ulcers of the foot in diabetes, 2016
InternationalWorking Group on the DiabeticFoot (IWGDF)
Guideline (free)
IWGDF guidance on the diagnosis and management of foot infections in persons with diabetes, 2016
InternationalWorking Group on the DiabeticFoot (IWGDF)
Guideline (free)
The management of diabetic foot: A clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine, 2016
Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine , USA
Guideline (free)
Diabetic foot problems: prevention and management, 2015
National Institute for Health and Care Excellence (NICE), UK
Guideline (free)
A clinical practice guideline for the use of hyperbaric oxygen therapy in the treatment of diabetic foot ulcers, 2015
Undersea and Hyperbaric Medical Society, USA
Guideline (free)
Guideline for the management of wounds in patients with lower-extremity neuropathic disease: an executive summary, 2013 
Wound, Ostomy and Continence Nurses Society, USA
Guideline (paid)
2012 Infectious Diseases Society of America Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections, 2012
Infectious Diseases Society of America , USA
Guideline (free)

QUALITY MEASURES

Setting CMS Program Developed by Measure ID Title Description/ Benchmark (when available)
OutpatientQPP - MIPS (*)
US Wound Registry
CDR1
Outcome measure: Adequate Off-loading of Diabetic Foot Ulcers at each visit, appropriate to location of ulcerPercentage of visits in which diabetic foot ulcers among patients aged 18 years and received adequate off-loading during a 12-month reporting period, stratified by location of the ulcer. As a benchmark, among eligible providers reporting this measure, per visit off-loading of DFUs is now achieved 59 % of the time
OutpatientQPP - MIPS (*)
US Wound RegistryCDR2Outcome measure: Diabetic Foot Ulcer (DFU) Healing or Closure
Percentage of diabetic foot ulcers among patients age 18 or older that have achieved healing or closure within 6 months, stratified by the Wound Healing Index. Healing or closure is defined as complete epithelialization without drainage or the need for a dressing over the closed ulceration, although venous compression would still be required.
Outpatient QPP - MIPS (*)
US Wound Registry CDR3 Process measure: Plan of Care Creation for Diabetic Foot Ulcer (DFU) and Venous Leg Ulcer (VLU) not Achieving 30% Closure at 4 Weeks after undergoing treatment with CTP
A plan of care needs to be created for patients that fail to achieve 30% of wound closure within 4 weeks of the application of the first CTP, and will include review of whether appropriate usual care has been implemented as well as whether further CTP applications are indicated
OutpatientQPP - MIPS (*)
US Wound Registry and the Undersea and Hyperbaric Medical Society (UHMS)
CDR8Appropriate use of hyperbaric oxygen therapy for patients with diabetic foot ulcerPercent of diabetic foot ulcers graded stage 3 or higher on the Wagner Grading System for Diabetic Foot Infections that received HBOT appropriately, among diabetic foot ulcers receiving HBOT during the reporting period. Prior to receiving HBOT patients must have met the following criteria: Have a diabetic foot ulcer that has not achieved 30% closure after four weeks of treatment, adequate offloading of the diabetic foot ulcer at each visit for four weeks of treatment, vascular screening performed, measurement of BMI with follow-up MIPS #128. As a benchmark, In 2000, the OIG published a report called, “Hyperbaric Oxygen Therapy, Its Use and Appropriateness,” in which it estimated that 32% of payments for HBOT were paid in error ($14.2 million that year).
OutpatientQPP - MIPS (*)
US Wound Registry 
CDR9Appropriate use of Cellular and/or Tissue Based Product (CTP) in diabetic foot ulcers (DFUs) or venous leg ulcer (VLUs) among patients 18 years or older
Percent of patients 18 or older with venous or diabetic foot ulcer who receive cellular and/or tissue based products (CTPs) appropriately. Appropriate Use of CTPs for a DFU or VLU is defined as use that adheres to Medicare coverage policy regarding the total number of applications over a specific timeframe. Regional Medicare Administrative  Carrier (MAC) policies differ but using the most restrictive Local Coverage Determination (LCD),  appropriate use is defined as:  No more than 10 applications per wound, CTP applications do not continue if the wound is unchanged in size or larger in size after 4 weeks have elapsed from the first application, CTP applications do not continue once the wound is 0.5 cm2 or smaller. Prior to application of a CTP, patient should undergo vascular assessment to exclude ischemia, control bioburden, and debride necrotic material, as well as provide other appropriate basic interventions such as compression of a venous ulcer or offloading of a diabetic foot ulcer. Currently the benchmark rate is only 23%.
OutpatientQPP - MIPS (*)
US Wound Registry and the Undersea and Hyperbaric Medical Society (UHMS)USWR16Outcome measure: Major Amputation in Wagner Grade 3, 4, or 5 DFUs Treated with HBOT
Percentage of ulcers of patients aged 18 years or older with a diagnosis of a Wagner Grade 3, 4, or 5 diabetic foot ulcer (DFU) whose ulcer has an outcome of major amputation 6 months after completion of a course of HBOT, stratified by the Wound Healing Index.
Outpatient
QPP - MIPS (*)
US Wound Registry 
USWR22
Patient Reported Nutritional Assessment and Intervention Plan in Patients with Wounds and Ulcers

The percentage of patients aged 18 years and older with a diagnosis of a wound or ulcer of any type who self-report nutritional screening with a validated tool (such as the Self-MNA® by Nestlé) as well as food insecurity assessment, AND for whom the clinician provides an intervention plan within the 12-month reporting period.


Outpatient
QPP - MIPS (*)
US Wound Registry 
USWR23
Non Invasive Arterial Assessment of patients with lower extremity wounds or ulcers for determination of healing potential
Percentage of patients aged 18 years or older with a non healing lower extremity wounds or ulcers that underwent a non-invasive arterial assessment once in a 12 month period, stratified by ABI, perfusion pressure, or oximetry
Outpatient
QPP - MIPS (*)
US Wound Registry
USWR24
Patient Reported Experience of Care: Wound Outcome
All eligible patients with wounds or ulcers who completed of Wound Outcome Questionnaire who showed 10% improvement at discharge or transfer to another site of care during the 12 month reporting period.
OutpatientQPP - MIPS (*)
US Wound Registry, SCG Health
SCG2Outcome Assessment for Patients Prescribed Ankle Orthosis for Ambulation and Functional Improvement 
Percentage of of patients 18 years and older who had at least two medical visits during the performance period, and for whom an ankle orthosis was prescribed to assist with ambulation AND report a significant improvement in ambulation and function with the orthosis using a standardized tool within the performance period
OutpatientQPP - MIPS (*)
US Wound Registry, SCG Health
SCG3Outcome Assessment for Patients Prescribed Foot Orthosis for Ambulation and Functional Improvement
Percentage of patients 18 years and older with a deformity of the foot or forefoot, who had at least two medical visits during the performance period, and for whom a foot orthosis was prescribed to assist with ambulation AND report a significant improvement in ambulation and function with the orthosis using a standardized tool within the reporting period
OutpatientQPP - MIPS (*)
US Wound Registry, SCG Health
SCG5Improvement in Quality of Life from Partial Foot, Prosthetics 
Percentage of patients 18 years and older with a prescription f or a partial foot prosthetic to assist with  ambulation whose health related quality of life (HRQoL) was assessed during at least two visits during  the performance period AND whose health related quality of life score stayed the same or improved
OutpatientQPP - MIPS (*)
MedicareMIPS1Diabetes: Hemaglobin A1c Poor Control
Percentage of patients 18-75 years of age with diabetes who had hemoglobin A1c > 9.0% during the measurement period
Outpatient
QPP - MIPS (*)
MedicareMIPS 126Diabetes Mellitus: Diabetic Food and Ankle Care, Peripheral Neuropathy - Neurological Evaluation
Percentage of patients aged 18 years and older with a diagnosis of diabetes mellitus who had a neurological examination of their lower extremities within 12 months
OutpatientQPP - MIPS (*)
MedicareMIPS 127Diabetes Mellitus: Diabetic Foot and Ankle Care, Ulcer Prevention - Evaluation of Footwear
Percentage of patients aged 18 years and older with a diagnosis of diabetes mellitus who were evaluated for proper footwear and sizing
Outpatient
QPP - MIPS (*)
Medicare
MIPS 128
Preventative Care and Screening: Body Mass Index (BMI) Screening and Follow-Up

Percentage of patients aged 18 years and older with a BMI documented during the current encounter or during the previous twelve months AND with a BMI outside of normal parameters, a follow-up plan is documented during the encounter or during the previous twelve months of the current encounter


Outpatient
QPP - MIPS (*)
MedicareMIPS 131
Pain Assessment and Follow-Up
Percentage of visits for patients aged 18 years and older with documentation of a pain assessment using a standardized tool(s) on each visit AND documentation of a follow-up plan when pain is present

* The Quality Payment Program (QPP) was implemented in the U.S. by Medicare in 2017. Merit-based incentive payment system (MIPS) is designed for eligible clinicians who bill under Medicare Part B. 


RESOURCES


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NOTE: This is a controlled document. This document is not a substitute for proper training, experience, and exercising of professional judgment. While every effort has been made to ensure the accuracy of the contents, neither the authors nor the Wound Reference, Inc. 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 omissions in the contents of the work.
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