eMeasure Title

CDR 1: Adequate Off-loading of DFUs each visit

eMeasure Identifier (Measure Authoring Tool) 436 eMeasure Version number 0.0.018
NQF Number None GUID 3da238d3-f9f9-4b4e-a6de-c4266cd9bf12
Measurement Period January 1, 20XX through December 31, 20XX
Measure Steward US Wound Registry
Measure Developer US Wound Registry
Endorsed By None
Description
Percentage of visits for patients aged 18 years and older with a diagnosis of a diabetic foot ulcer who received adequate diabetic foot ulcer off-loading at each visit during a 12-month reporting period.
Copyright
None
Disclaimer
None
Measure Scoring Proportion
Measure Type Process
Measure Item Count
Encounter, Performed: Adult Outpatient Visit
Stratification
None
Risk Adjustment
None
Rate Aggregation
None
Rationale
Offloading the pressure from a diabetic foot ulcer allows the wound to heal by secondary intention when the wound is appropriately dressed because pressure is a causal factor for neuropathic foot ulcers. The gold standard is total contact casting in which the entire foot is enclosed in a solid structure that is retained until the wound is healed. However, when the patient has moderate or severe ischemia this treatment is contraindicated. An alternative to total contact casting is a removable device such as a CROW walker which still maintains ankle immobility. For patients who are able to use them properly, crutches may be effective. For patients who do not ambulate, the use of a wheelchair may provide effective offloading. A recent consensus statement with a systematic review of the literature ranked the overall strength of evidence for diabetic foot ulcer off-loading as moderate. However, off-loading is widely considered the single most important intervention necessary to accomplish wound healing in the management of the diabetic foot ulcer.
Process of off-loading in relation to outcome:
In a review of 9 randomized controlled trials of total contact casting (TCC) (Helm 1984; Sinacore 1987; Walker 1987; Mueller 1989; Meyerson 1992; Birke 1992; Lavery 1997; Armstrong 2001; Birke 2002), TCC healed 89% of DFUs on an average of 43 days. Thus, the process of off-loading has been directly linked to the outcome of DFU healing from multiple RCTs. Furthermore, patients treated with TCC experienced a higher percentage of healed ulcers in a shorter period of time than with other advanced therapeutics based on RCTs for other interventions, although direct comparisons with other advanced therapeutics have not been performed since no advanced therapeutic should be used in the absence of appropriate off-loading.
Gap in Practice:
Despite the fact that DFU off-loading is widely considered to be the standard of care by all professional organizations, evidence suggests that it is not practiced. Total contact casting is used in fewer than 6% of DFUs among a large population of outpatients, and off-loading of any type was documented to be used in only 16% of DFUs, even among patients seen at hospital based outpatient wound centers, according to data collected by the U.S. Wound Registry. (“Why Is it So Hard to Do the Right Thing in Wound Care?" Fife CE, Carter MJ, Walker D. Wound Rep Reg (2010) 18 154–158; Diabetic Foot Ulcer Off-Loading: The Gap Between Evidence and Practice. Data from the U.S. Wound Registry, Fife CE, Carter M, Walker D, Thomson B, Eckert KA, Advances in Skin and Wound Care, in press, 2014)
Clinical Recommendation Statement
The Cochrane Collaboration (2013) has concluded that pressure relief is one of the primary interventions for successful treatment of diabetic foot ulcers (the other 2 being: ensuring adequate blood supply and treatment of infection). Non-removable casts provide the most effective pressure-relieving intervention for the healing of diabetic foot ulcers, but the use of this intervention has to be balanced against restrictions in movement and possible decrease in quality of life. Where non-removable casts are not possible, other interventions such as removable devices may be considered. The best option for off-loading may also be determined by the location of the pressure ulcer on the foot.
Improvement Notation
Higher score indicates better quality.
Reference
Snyder RJ, Kirsner RS, Warriner RA, 3rd, et al: Consensus recommendations on advancing the standard of care for treating neuropathic foot ulcers in patients with diabetes. Ostomy Wound Manage 56: S1, 2010.
Reference
Frykberg RG, Zgonis T, Armstrong DG, et al: Diabetic foot disorders. A clinical practice guideline (2006 revision). J Foot Ankle Surg 45: S1, 2006.
Reference
Steed DL, Attinger C, Brem H, et al: Guidelines for the prevention of diabetic ulcers. Wound Repair Regen 16: 169, 2008.Lewis J, Lipp A: Pressure-relieving interventions for treating diabetic foot ulcers. Cochrane Database Syst Rev 1: CD002302, 2013.Bus SA
Reference
Waaijman R, Arts M, et al: Effect of custom-made footwear on foot ulcer recurrence in diabetes: a multicenter randomized controlled trial. Diabetes Care 36: 4109, 2013.
Reference
Katz IA, Harlan A, Miranda-Palma B, et al: A randomized trial of two irremovable offloading devices in the management of neuropathic diabetic foot ulcers. Diabetes Care 28: 555, 2005.
Reference
Armstrong DG, Nguyen HC, Lavery LA, et al: Off-loading the diabetic foot wound: a randomized clinical trial. Diabetes Care 24: 1019, 2001.
Reference
Gutekunst DJ, Hastings MK, Bohnert KL, et al: Removable cast walker boots yield greater forefoot off-loading than total contact casts. Clin Biomech (Bristol, Avon) 26: 649, 2011.
Reference
Bus SA, Valk GD, van Deursen RW, et al: The effectiveness of footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in diabetes: a systematic review. Diabetes Metab Res Rev 24: S162, 2008.
Reference
Armstrong DG, Lavery LA, Wu S, et al: Evaluation of removable and irremovable cast walkers in the healing of diabetic foot wounds: a randomized controlled trial. Diabetes Care 28: 551, 2005.
Reference
Piaggesi A, Macchiarini S, Rizzo L, et al: An off-the-shelf instant contact casting device for the management of diabetic foot ulcers: a randomized prospective trial versus traditional fiberglass cast. Diabetes Care 30: 586, 2007.
Reference
Faglia E, Caravaggi C, Clerici G, et al: Effectiveness of removable walker cast versus nonremovable fiberglass off-bearing cast in the healing of diabetic plantar foot ulcer. A randomized controlled trial. Diabetes Care 33: 1419: 2010.
Reference
Fife CE, Carter MJ, Walker D: Why is it so hard to do the right thing in wound care? Wound Repair Regen 18: 154, 2010.
Reference
Wu SC, Jensen JL, Weber AK, et al: Use of pressure offloading devices in diabetic foot ulcers: do we practice what we preach? Diabetes Care 31: 2118, 2008.
Reference
Reiber GE, Smith DG, Wallace C, et al: Effect of therapeutic footwear on foot reulceration in patients with diabetes: a randomized controlled trial. JAMA 287: 2552, 2002.
Reference
Lavery LA, Vela SA, Fleischli JG, et al: Reducing plantar pressure in the neuropathic foot: a comparison of footwear. Diabetes Care 20: 1706, 1997.
Reference
Lewis J, Lipp A: Pressure-relieving interventions for treating diabetic foot ulcers. Cochrane Database Syst Rev 1: CD002302, 2013.
Reference
Bus SA, Waaijman R, Arts M, et al: Effect of custom-made footwear on foot ulcer recurrence in diabetes: a multicenter randomized controlled trial. Diabetes Care 36: 4109, 2013.
Reference
Bus SA, Valk GD, van Deursen RW, et al: The effectiveness of footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in diabetes: a systematic review. Diabetes Metab Res Rev 24: S162, 2008.
Reference
In diabetic foot ulcers, adequate offloading should be ensured thorough wound closure. (Ostomy and Continence Nurses Society (A level evidence) (WOCN 2004). Available at: http://www.guideline.gov/summary/summary.aspx?doc_id=5912&nbr=003898&string=diabetic+AND+foot+AND+ulcers Wound
Definition
Definition of Adequate Offloading: Adequate measures include total contact casting, the use of a CROW walker or crutches when walking, or the use of a wheelchair. While custom shoes or molded shoe inserts may be adequate, simple shoe modifications have been shown to be inadequate in some studies.
Guidance
This measure is to be reported for every encounter during the measurement period.
Transmission Format
TBD
Initial Population
All visits of patient aged 18 years and older with a diagnosis of diabetic foot ulcer.      
Denominator
Equal to Initial Population
Denominator Exclusions
Death, Palliative care patients, DFU patients receiving amputation, DFU patients seen for consultations only, DFU patients with <2 visits
Numerator
Those visits with documented adequate diabetic foot ulcer off-loading during the reporting period
Numerator Exclusions
None
Denominator Exceptions
None
Supplemental Data Elements
For every patient evaluated by this measure also identify payer, race, ethnicity and sex.

Table of Contents


Population Criteria

Data Criteria (QDM Variables)

Data Criteria (QDM Data Elements)

Supplemental Data Elements

Risk Adjustment Variables


Measure Set
None