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Diabetic Foot Ulcer - Hyperbaric Oxygen Therapy

INTRODUCTION

Treatment Protocol Guidelines

The following hyperbaric medicine treatment protocol is based upon the recommendations of the Hyperbaric Oxygen Committee of the Undersea and Hyperbaric Medical Society.

The protocol is designed to standardize therapeutic regimens, whenever possible, in order to optimize clinical outcomes and cost-effectiveness, and provide the basis for prospective analysis of data. Care plans may need to be individualized according to a particular patient’s general medical condition and relevant medical history. When the clinical decision is to deviate from the protocols, including the upper treatment threshold, a case audit should be initiated. 

Medical Necessity

The listing of treatment indications for hyperbaric oxygen therapy represent the commonly accepted uses.  The approved uses and indications are standardized across the country and can be found within the National Coverage Determination (NCD) 20.29. [1]

It is recommended, therefore, that contact is made (pre-authorization) with each patient’s insurance company in order to clarify benefits. Each health insurance company’s decision-making process for inclusion or exclusion of a particular indication for hyperbaric oxygen therapy is based upon several factors. Literature-specific reviews by panels of experts, technology assessments, resourcing of evidence-based repositories and historical precedent are tools used for “medically necessary‟ determination. 

TREATMENT PROTOCOL


 HBO request requirements checklist   |  Sample Physician Order   | $ ICD-10 Crosswalk   |  Treatment Table


Objectives

  1. Overcome regional and/or local ischemia/hypoxia, thereby stimulating oxygen-dependent components of wound repair.
  2. Enhance host antimicrobial responses.
  3. Stimulate angiogenic healing responses to the point of local host competency.

Diagnosis

IDDM or NIDDM patient with a lower extremity ulcer refractory to standard wound therapy for at least 30 days.

Criteria for HBO therapy

(All of the following should exist)

  1. Documented evidence of lower extremity wound(s) healing failure despite at least 30 days of standard wound are.
  2. Wagner Grade 3 ulcer or greater for Medicare patients and some commercially insured.
  3. Transcutaneous oximetry evidence of reversible local tissue hypoxia.
  4. Risk benefit ratio in favor of offering hyperbaric oxygen therapy.

Work-Up
Considerations 

  1. Comprehensive history
  2. Physical examination, ABIs
  3. Labs to consider, order or review:
    • CBC
    • Blood Chemistry Profile
    • Sedimentation Rate 
  4. Wound Cultures 
  5. HbA1-C
  6. Transcutaneous oxygen assessment
  7. PV laboratory assessment, where indicated
  8. Wound photography. 
  9. Chest x-ray; order or review, where indicated
  10. Baseline visual acuity assessment
  11. Nutritional assessment; dietary management; blood glucose control
  12. No (limit) use of nicotine products during hyperbaric treatment course

Treatment

  1. After signed informed consent:
  2. Hyperbaric oxygen therapy at 2.0 ATA (with a minimum tcPO2 value of 200 mmHg on the first treatment). Oxygen for 90 minutes of oxygen breathing. Titrate chamber pressure every 10 minutes to achieve a minimum of 200 mmHg where necessary. Institute air breaks per Table 3 if treatment pressure exceeds 2.0 ATA. Do not exceed 2.5 ATA. Treatments are given on a QD basis, usually as an outpatient.
  3. Treatments may be increased to BID with inpatients, and where indicated. (for example: limb threatening ulcers).
  4. In-chamber transcutaneous oxygen assessment during the first hyperbaric treatment. A minimum value of 200 mmHg is required to confirm adequate reversal of local hypoxia. Increase (titrate) chamber pressure every 10 minutes to reach this minimum value, where necessary.
  5. Maintain medical management, as indicated/previously ordered
  6. Weekly wound photography
  7. Re-evaluate after 14 treatments.  Repeat normobaric transcutaneous oximetry.
  8. Where no evidence of healing response is apparent, either clinically or based on TCOM values, work up patient for additional etiologies.  Continue on to 20 treatments if no other complicating factors are identified, then reassess.
  9. Where healing response is clinically evident and periwound tissue oxygen states have normalized (>40 mmHg), hold HBO and follow for sustained healing responses. 
  10. If transcutaneous oximetry indicates improved angiogensis but periwound values have not reached 40 mmHg, continue HBO on a weekly basis, until values reach/exceed 40 mmHg. Hold HBO and follow for sustained healing responses.
  11. Dressing change in conjunction with HBO once daily, unless indicated/ ordered otherwise.
  12. Re-evaluate and document weekly for wound status (appearance and dimensions), wound healing, and normalized tissue oximetry.
  13. Encourage patient to avoid/eliminate nicotine products during the hyperbaric treatment course.

Follow-Up

  1. Confirm continued healing responses. Consider additional HBO if wound appears to plateau  despite normalized tissue oximetry.
  2. Maintain appropriate wound care in resolving cases. 
  3. Off-loading, where appropriate; consider specialized footwear
  4. Visual acuity assessment.

Treatment Threshold

14 – 40 treatments

ICD-9 to ICD-10 Crosswalk

Refer to the ICD-10 Guideline for the appropriate ICD-10 code     

Notes

  1. In diabetic patients, finger stick for blood glucose prior to each treatment, if sample not drawn and available within 60 minutes prior to HBO. Repeat blood glucose post HBO.
  2. Avoid petroleum-based dressings and ointments.
  3. It is important to confirm that this indication meets the “medically necessary‟ reimbursement standard of the patient’s health insurance plan. 
  4. A Wagner Grade 3 diabetic ulcer meets insurance company compliance criteria. 
  5. It would not be beneficial to proceed with a course of HBO therapy if reversible local hypoxia had not been confirmed.

DOCUMENTATION

The UHMS Guidelines Committee recommends patients with Wagner ≥3 diabetic foot ulcers that have not healed for 30 days have Hyperbaric Oxygen Therapy added to the Standard of Care to reduce the risk of major amputation and incomplete healing. Urgent HBOT should be added to the standard of care for patients with Wagner ≥3 diabetic foot ulcers who have had surgical debridement of an infected foot (e.g., partial toe or foot amputation, I&D of deep space abscess, necrotizing soft tissue infection) to reduce the risk of major amputation and incomplete healing. See also:

History and Physical

  • An initial assessment including a history and physical that clearly substantiates the condition for which HBO is recommended.
  • Prior medical, surgical and/or hyperbaric treatments.
  • Failure to respond to standard wound care occurs when there is no documentation of measurable signs of healing for at least 30 consecutive days.

Physical Exam

  • An initial assessment including a history and physical that clearly substantiates the condition for which HBO is recommended.
  • The DFU duration is > 1 month.
  • Documentation must demonstrate an ulcer with deep abscess, bone involvement (osteomyelitis), joint sepsis, localized gangrene or gangrene of the foot. Wagner Grade 3 ulcer or greater.
  • Documented evidence of lower extremity wound(s) healing failure despite at least 30 days of standard wound care.
    • Decrease in margin size or depth of the wound
    • Formation of healthy granulation tissue (NOT reactive mounds or polyps of granulation tissue)
    • Epithelial growth or advancing margins of epithelium
    • Documentation of vascular status, assessment and correction of any vascular problems in the affected limb.
    • Transcutaneous oximetry evidence of reversible local tissue hypoxia.
    • Include foot pulses and ABI
  • Documentation of optimization of nutritional status
    • Albumin
    • Pre-Albumin
    • Use a validated tool such as a Nestle mini nutritional assessment (MNA) within the 12 month reporting period.  
  • Documentation of optimization of glucose control
    • HgbA1-C level; the results may be obtained from the primary care physician.
  • Documentation of maintenance of a clean, moist bed of granulation tissue with appropriate dressings
    • Initial Ulcer size - beginning of 30 days of standard wound care.
    • Ulcer size - Following 30 days of standard wound care
  • Documentation of efforts for adequate off-loading (the single most important intervention for healing)
    • Adequate refers to Total Contact Casting ,CROW walker, Crutches for walking or wheelchair.
  • Documentation of necessary treatment to resolve any infection that might be present.

Risk Assessment

  • Risk benefit ratio in favor of offering hyperbaric oxygen therapy, example statement:   

 "The patient was informed of the possible risks and complications of hyperbaric oxygen therapy. These include, but are not limited to, fire, barotrauma of the ears, sinuses, and lungs to include air embolism, central nervous system oxygen toxicity resulting in seizure, cataracts, myopia, and exacerbation of congestive heart failure.  Having no absolute contraindication to hyperbaric oxygen therapy the patient will be offered treatment at 2.0 ATA for 90 minutes. Twenty treatments will initially be provided on a once daily basis Monday through Friday. Thereafter, a re-evaluation of the patient’s clinical progress will be in order to determine if additional treatments may be required."

Impression

1. Diabetic Complications Code – (ICD-10 E series) 

2. Wound diagnosis code – (ICD-10 L series)

Plan

Example Statement supporting the role of hyperbaric oxygen therapy:

Mechanisms by which HBO has been shown to be beneficial include the following:

  • Overcome regional and/or local ischemia/hypoxia, thereby stimulating oxygen-dependent components of wound repair.
  • Enhance host antimicrobial responses.
  • Stimulate angiogenic healing responses to the point of local host competency.

Sample Order

CLINICAL EVIDENCE AND RECOMMENDATIONS  

CODING


APPENDIX

Summary of Evidence

We reviewed the clinical guidelines, systematic reviews, meta-analyses and clinical trials summarized below. Applying the GRADE framework to the combined body of evidence, we found that:

  • Moderate certainty evidence supports the use of HBO as an adjunctive therapy to promote DFU healing and prevent amputation (evidence level B). The systematic reviews and meta-analyses [4] [5] included the same RCTs. Both agreed that HBO as an adjunctive therapy significantly improved DFU healing, however they differed in regards to amputation prevention. The 2015 Cochrane meta-analysis [5] calculated the relative risk between intervention and control, and the 2016 SVS-commissioned meta-analysis [4]  calculated the Peto odds ratio, which was considered by authors of the 2016 meta-analysis as more precise. Clinical guidelines also relied on the same RCTs to grade evidence, however their classification system differed. In analyzing the RCTs, most were small and were at high or moderate risk of bias, however one larger RCT (94 participants) [6] was better designed and can be considered of moderate evidence level (evidence level B)

- Systematic reviews and meta-analyses

  • A 2016 systematic review and meta-analysis [4] included 18 studies, of which 9 were RCTs, enrolling 1526 participants in total. Based on six RCTs, HBOT was associated with increased healing rate (OR, 14.25; 95% CI, 7.08-28.68, I2 = 0%) and reduced major amputation rate (OR, 0.30; 95% CI, 0.10-0.89, I2 = 59%) compared with conventional therapy. The quality of this evidence is considered low to moderate, potentially downgraded due to methodologic limitations of the included studies. In the experimental groups, HBO was given in addition to conventional therapy (wound care and offloading). In most studies, HBO was given at 2.0 to 3.0 atmospheric pressure in daily 90-minute sessions in a monoplace or multilplace chamber. On average, patients received 30 sessions, although a few patients in one study received 60 sessions. [7] [8] Authors concluded that there is low- to moderate-quality evidence supporting the use of HBO as an adjunctive therapy to enhance DFU healing and potentially prevent amputation. 
  • A 2015 Cochrane systematic review and meta-analysis [5] pooled data of 5 RCTs [6] [8] [9] [10] , showed an increase in the rate of ulcer healing (RR: 2.35, 95% confidence interval (CI) 1.19 - 4.62; P = 0.01) with HBO at six weeks but this benefit was not evident at longer-term follow-up at one year. There was no statistically significant difference in major amputation rate (pooled data of 5 RCTs with 312 participants, RR 0.36, 95% CI 0.11 - 1.18). Authors concluded that In people with foot ulcers due to diabetes, HBOT significantly improved the ulcers healed in the short term but not the long term and the trials had various flaws in design and/or reporting that means we are not confident in the results. 

- Clinical guidelines

  • The 2016 Society for Vascular Surgery in association with American Podiatric Medical Association (SVS) [11], the 2016 Wound Healing Society (WHS) [12], the 2012 Wound, Ostomy, and Continence Nurses Society (WOCN) (Wound, Ostomy, and Continence Nurses Society (WOCN) 2012) [13], the 2014 Undersea and Hyperbaric Medicine Society (UHMS)  [14] and the 2017 European Committee for Hyperbaric Medicine (ECHM)  [15] guidelines support the use of HBO as an adjunctive therapy to promote DFU healing and prevent amputation
Intervention SVSWHSWOCNUHMSECHM
Hyperbaric oxygen therapy as adjunctive therapy to promote DFU healing and reduce amputation ratesGrade 2BLevel ILevel BAHA Class IGrade 2B

- Observational studies: 

  • A recent longitudinal observational cohort study by Margolis et al [16] on 6259 individuals with diabetes, adequate lower limb arterial perfusion, and foot ulcer found that the use of HBO neither improved the likelihood of healing nor prevented amputation in a cohort of patients defined by Centers for Medicare and Medicaid Services eligibility criteria.The authors concluded that the usefulness of HBO in patients with DFUs needs to be reevaluated. 






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REFERENCES

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  2. Alavi, Afsaneh; Sibbald, R Gary; Mayer, Dieter; Goodman, Laurie; Botros, Mariam; Armstrong, David G; Woo, Kevin; Boeni, Thomas; Ayello, Elizabeth A; Kirsner, Robert S et al. Diabetic foot ulcers: Part II. Management. Journal of the American Academy of Dermatolog.... Date of publication 2014 Jan 1;volume 70(1):21.e1-24; quiz 45.
  3. . National Coverage Determination (NCD) for Hyperbaric Oxygen Therapy (20.29) . Date of publication 2017 Oct 7;volume ():.
  4. Elraiyah T, Tsapas A, Prutsky G, Domecq JP, Hasan R, Firwana B, Nabhan M, Prokop L, Hingorani A, Claus PL, Steinkraus LW, Murad MH et al. A systematic review and meta-analysis of adjunctive therapies in diabetic foot ulcers. Journal of vascular surgery. Date of publication 2016 Feb 1;volume 63(2 Suppl):46S-58S.e1-2.
  5. Guo S, Counte MA, Gillespie KN, Schmitz H et al. Cost-effectiveness of adjunctive hyperbaric oxygen in the treatment of diabetic ulcers. International journal of technology assessment in health care. Date of publication 2003 Oct 1;volume 19(4):731-7.
  6. Hingorani, Anil; LaMuraglia, Glenn M; Henke, Peter; Meissner, Mark H; Loretz, Lorraine; Zinszer, Kathya M; Driver, Vickie R; Frykberg, Robert; Carman, Teresa L; Marston, William; Mills, Jose... et al. 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. Journal of Vascular Surgery. Date of publication 2016 Feb 1;volume 63(2 Suppl):3S-21S.
  7. Kessler L, Bilbault P, Ortéga F, Grasso C, Passemard R, Stephan D, Pinget M, Schneider F et al. Hyperbaric oxygenation accelerates the healing rate of nonischemic chronic diabetic foot ulcers: a prospective randomized study. Diabetes care. Date of publication 2003 Aug 1;volume 26(8):2378-82.
  8. Khandelwal S, Chaudhary P, Poddar DD, Saxena N, Singh RA, Biswal UC et al. Comparative Study of Different Treatment Options of Grade III and IV Diabetic Foot Ulcers to Reduce the Incidence of Amputations. Clinics and practice. Date of publication 2013 Feb 21;volume 3(1):e9.
  9. Kranke, P; Mh, Bennett; M, Martyn-st James; Schnabel, A; Se, Debus; Weibel, S et al. Hyperbaric oxygen therapy for chronic wounds ( Review ) Cochrane Database of Systematic Reviews. Date of publication 2017 Oct 7;volume (6):.
  10. Lavery, Lawrence A; Davis, Kathryn E; Berriman, Sandra J; Braun, Liza; Nichols, Adam; Kim, Paul J; Margolis, David; Peters, Edgar J; Attinger, Chris et al. WHS guidelines update: Diabetic foot ulcer treatment guidelines. Wound Repair and Regeneration. Date of publication 2016 Feb 1;volume 24(1):112-126.
  11. Löndahl M, Landin-Olsson M, Katzman P et al. Hyperbaric oxygen therapy improves health-related quality of life in patients with diabetes and chronic foot ulcer. Diabetic medicine : a journal of the British Diabetic Association. Date of publication 2011 Feb 1;volume 28(2):186-90.
  12. Ma L, Li P, Shi Z, Hou T, Chen X, Du J et al. A prospective, randomized, controlled study of hyperbaric oxygen therapy: effects on healing and oxidative stress of ulcer tissue in patients with a diabetic foot ulcer. Ostomy/wound management. Date of publication 2013 Mar 1;volume 59(3):18-24.
  13. Margolis, David J; Gupta, Jayanta; Hoffstad, Ole; Papdopoulos, Maryte; Glick, Henry A; Thom, Stephen R; Mitra, Nandita et al. Lack of effectiveness of hyperbaric oxygen therapy for the treatment of diabetic foot ulcer and the prevention of amputation: a cohort study. Diabetes Care. Date of publication 2013 Jul 1;volume 36(7):1961-1966.
  14. Mathieu, Daniel; Marroni, Alessandro; Kot, Jacek et al. Tenth European Consensus Conference on Hyperbaric Medicine: recommendations for accepted and non-accepted clinical indications and practice of hyperbaric oxygen treatment. Diving and hyperbaric medicine. Date of publication 2017 Mar 1;volume 47(1):24-32.
  15. Undersea and Hyperbaric Medical Society Hyperbaric Oxygen Committee,, et al. Hyperbaric Oxygen Therapy Indications . Date of publication 2014 Oct 7;volume ():.
  16. Crawford PE, Fields-Varnado M, WOCN Society. et al. Guideline for the management of wounds in patients with lower-extremity neuropathic disease: an executive summary. Journal of wound, ostomy, and continence nursing : official publication of The Wound, Ostomy an.... Date of publication 2013 Jan 1;volume 40(1):34-45.
  17. . National Coverage Determination (NCD) for Hyperbaric Oxygen Therapy (20.29) . Date of publication 2017 Oct 7;volume ():.

SUBTOPICS