eMeasure Title

CDR 8: Appropriate Use of Hyperbaric Oxygen Therapy for Patients with Diabetic Foot Ulcers

eMeasure Identifier (Measure Authoring Tool) 443 eMeasure Version number 0.0.006
NQF Number None GUID 08bd57e2-09b5-4114-93c7-4756e9445781
Measurement Period January 1, 20XX through December 31, 20XX
Measure Steward US Wound Registry
Measure Developer US Wound Registry
Endorsed By None
Description
Percentage diabetic foot ulcers that received hyperbaric oxygen therapy (HBOT) appropriately.
Copyright
None
Disclaimer
None
Measure Scoring Proportion
Measure Type Process
Measure Item Count
Occurrence A of Diagnosis: Diabetic Foot Ulcer Grouping
Stratification
None
Risk Adjustment
None
Rate Aggregation
None
Rationale
Hyperbaric Oxygen Therapy (HBOT) has been demonstrated with highest AHA Level 1A evidence to be of benefit as adjunctive therapy for the healing of diabetic foot ulcers (DFUs) 1,2,3,4,5.  HBOT is often included in a comprehensive plan of care for patients with advanced diabetic foot ulcers even though it is not a type of wound care per se. HBO2 works mechanistically by inducing angiogenesis and vasculogenesis 6,7 within the microangiopathic wound. Among randomized controlled trials (RCT) performed for various forms of treatment for diabetic foot ulcers, only HBO2 trials have included Wagner 3 or higher DFUs,8 giving it a unique place in the armamentarium of the wound care clinician for the most severe and limb threatening DFUs.

However, neovascularization of the wound cannot be achieved if large vessel ischemia has not been assessed and optimally and repaired prior to initiating HBOT. Thus, vascular assessment and should be done prior to initiating HBOT.  HBOT is also not effective if it is not part of a multidisciplinary approach to therapy with the concomitant use of treatments directed at all the impediments to healing.9  If optimally revascularized peripheral arterial disease, appropriate debridement, infection management, glycemic control and off-loading the wound are not maintained while HBOT is undertaken, the wound will not heal despite any success of HBOT in inducing good granulation tissue with neovascularization. 

Gap in Practice:
A recent retrospective analysis of a large hyperbaric and wound care database by Margolis 10concluded that hyperbaric oxygen therapy (HBOT) was not effective in healing diabetic foot ulcers or preventing amputation. The lack of effectiveness of HBO2T for DFU in this retrospective observational cohort study does not dispute the efficacy of HBO2T for DFU shown in prospective RCTs. However, the study confirms that if not used appropriately, HBOT does not provide benefit beyond conventional wound care.  Adherence to appropriate patient selection and treatment criteria are essential to the effectiveness of HBO2. HBOT is appropriate when a after appropriate vascular assessment (with revascularization if needed), moist wound care, and off-loading have failed to effect improvement within 4 weeks.
Clinical Recommendation Statement
 
Improvement Notation
Higher score indicates better quality
Reference
Londahl M, Katzman P, et al. Hyperbaric oxygen therapy facilitates healing of chronic foot ulcers in patients with diabetes. Diabetes Care. 2013;33(5):998-1003
Reference
Abidia A, Laden G, Kuhan G, et al. The role of hyperbaric oxygen therapy in ischaemic diabetic lower extremity ulcers: A double-blind randomised-controlled trial. Eur J Vasc Endovasc Surg. 2003;25:513-518.
Reference
Faglia E, Favales F, Aldeghi A, et al. Adjunctive systematic hyperbaric oxygen therapy in treatment of severe prevalently ischemic diabetic foot ulcer. A randomized study. Diabetes Care. 1996;19:1338-1343.
Reference
Doctor N, Pandya S, Supe A. Hyperbaric oxygen therapy in diabetic foot. J Postgrad Med. 1992;38:112-114.
Reference
Liu R, Li L, Yang M, et al. Systematic Review of the Effectiveness of Hyperbaric Oxygenation Therapy in the Management of Chronic Diabetic Foot Ulcers. Mayo Clin Pro. 2013;88(2):166-175.
Reference
Hopf HW, Kelly M, Shapshak D. (2008). Oxygen and the basic mechanism of wound healing. In: Neuman, T and Thom, S Physiology and Medicine of Hyperbaric Oxygen Therapy. Philadelphia: Saunders. 203-228. 
Reference
Thom SR, Milovanova TN, Yang M, et al. Vasculogenic stem cell mobilization and wound recruitment in diabetic patients: increased cell number and intracellular regulatory protein content associated with hyperbaric oxygen therapy. Wound Rep Regen. 2011;19(2):149-161.
Reference
Carter MJ, Fife CE, Bennett M. Effectiveness of hyperbaric oxygen therapy as an adjunct procedure in the treatment of diabetic foot ulcers. Diabetes Care [letter]. 2013; (in press) 
Reference
Brem H, Sheehan P, Boulton AJM. Protocol for treatment of diabetic foot  ulcers. Am J Surg. 2004;187(5A):1S-10S.
Reference
Margolis DJ, Gupta J, Hoffstad O, et al. Lack of effectiveness of hyperbaric oxygen therapy for the treatment of diabetic foot ulcer and prevention of amputation.  Diabetes Care 2013 Feb 19. [Epub ahead of print].
Definition
None
Guidance
None
Transmission Format
TBC
Initial Population
Diabetic foot ulcers receiving HBOT treatment during the reporting period.
Denominator
Equal to the Initial Population
Denominator Exclusions
None
Numerator
Those diabetic foot ulcers graded stage 3 or higher on the Wagner Grading System for Diabetic Foot Infections that received HBOT appropriately.

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
• Not using a saline wet to dry dressing on the wound
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