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Diabetic Foot Ulcer - Hyperbaric Oxygen Therapy

Diabetic Foot Ulcer - Hyperbaric Oxygen Therapy

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.  Clinical protocols and/or practice guidelines are systematically developed statements that help physicians, other practitioners, case managers and clients make decisions about appropriate health care for specific clinical circumstances.   

Protocols allow health providers to offer evidence-based, appropriate, standardized diagnostic treatment and care services to patients undergoing hyperbaric oxygen therapy (HBOT).  Evidenced-based medicine offers clinicians a way to achieve improved quality, improved patient satisfaction, and reduced costs.  Utilization Review should be initiated when clinical decisions result in deviation from or modification of treatment protocols.  This includes any course of treatment at or above the recognized threshold limits. 

Medical Necessity

Medicare.gov defines “medically necessary” as “health-care services or supplies needed to prevent, diagnose, or treat an illness, injury, condition, disease, or its symptoms and that meet accepted standards of medicine.” 

The following condition meets coverage indications per the National Coverage Determination (NCD) 20.29.[1] Continued HBO therapy without documented evidence of effectiveness does not meet the Medicare definition of medically necessary treatment. Thorough re-evaluation should be made at least every 30 days for documentation of response to therapy. 

TREATMENT PROTOCOL


Background Patients with diabetes are at high risk for developing foot ulcers due to neuropathy, peripheral arterial occlusive disease, impaired white blood cell response to infection and cellular dysfunction. Despite standard wound care, foot ulcerations can progress and complications, such as cellulitis, deep tissue necrosis, abscess formation, and osteomyelitis may arise. Deep diabetic foot ulcers (DFU) with abscess, osteomyelitis or joint sepsis are characterized as Wagner Grade 3. Among other requirements listed on Medicare determinations, a DFU needs to be classified as Wagner 3 or above to justify treatment with HBO. For more information on Wagner and other DFU classifications see "Diabetic Foot Ulcers - Classification Systems"

Goals of HBOT

To restore the following oxygen-dependent processes, necessary for wound healing:
  • Inflammatory and repair functions of neutrophils, fibroblasts, macrophages and osteoclasts
  • Collagen deposition
  • Angiogenesis
  • Resistance to infection
  • Intracellular leukocyte bacterial killing

Diagnosis

Patient with diabetes with lower extremity ulcer of neuropathic, neuroischemic or ischemic etiology [2]  

Hyperbaric Criteria


  • The patient has type 1 or 2 diabetes and a lower extremity ulcer due to diabetes AND 
  • The ulcer is a Wagner grade 3 or higher AND
  • The patient has failed a 30-day standard wound therapy regimen that included assessment and attempts to correct vascular abnormalities, optimizing diabetes control, nutrition, surgical debridement, moist wound healing, off-loading, and treatment of underlying infection. 
  • Transcutaneous Oximetry (TCOM) evidence of reversible local tissue hypoxia. 
  • Careful analysis of each case based on the criteria above   

Evaluation 

    • Comprehensive history
    • Physical Exam:
      • Foot anatomy (obvious deformities and previous amputations)
      • Neurologic (monofilament testing, vibration, pinprick sensation)
      • Vascular (pulse palpation, doppler pulses, ankle brachial index (ABI), Skin perfusion pressure (SPP), Fluorescence angiography, TCOM.
      • Wound exam and photographic documentation. Assess whether wound has decreased at least 50% over four weeks of adequate treatment. [3]   
    • Imaging Studies: Plain Radiographs, MRI, Bone Scan
    • Laboratory Studies: 
      • Complete Blood Count (CBC)
      • HbA1-C
      • Estimated Average Glucose
      • Comprehensive Metabolic Profile (CMP)
      • Albumin
      • Prealbumin
      • Erythrocyte Sedimentation Rate (ESR)
      • C-Reactive Protein (CRP)

      • Perform normobaric TCOM in normobaric air and pressure. See topic "Transcutaneous Oximetry"
        • Values below 25-40 mmHg have been associated with poor healing of wound and amputation flaps. Hypoxia (i.e. TCOM is <40 mm Hg) generally defines wounds appropriate for HBOT
        • Lack of hypoxia (i.e. TCOM >40-50 mm Hg) defines wounds that have high healing potential from an oxygen standpoint and HBO is not needed for its ability to improve tissue oxygenation.
      • Assess TCOM in normobaric pressure and 100% oxygen:
        • In normal subjects breathing 100% oxygen at normobaric pressure, TCOM values on the extremity increase to a value > 100 mmHg
        • If the wound is hypoxic while breathing normobaric air, and TCOM values obtained while breathing 100% normobaric oxygen increase to above 35 mm Hg, with a significant rise > 50% above the normobaric air value, there is a likelihood of benefiting from HBO.[4]
        • A low TCOM normobaric air value followed by a response to breathing normobaric 100% oxygen of >100 mm Hg might indicate that the patient has minimal arterial disease and that any low air values are due to a diffusion barrier. This pattern of response is predictive of healing.  
      • Nutritional assessment; dietary management; blood glucose control and measurement of body mass index (BMI)
      • Baseline and as needed visual acuity assessment for evaluation of progressive myopia
      • Evaluation of tympanic membranes pre and post-treatment as needed
      • Smoking/nicotine cessation

      Treatment

      • Hyperbaric oxygen therapy at 2.0 to 2.5 ATA for 90 minutes of oxygen breathing. (Table 1 or Table 3). Initiate Air Breaks if treating at pressures > 2.0 ATA
      • HBO sessions may be provided on a daily basis 5-7 times per week or twice daily in patients with serious infections requiring hospitalization for intravenous antibiotics, aggressive surgical intervention, and better diabetes control. 
      • 20-40 postoperative HBO sessions will be required to achieve sustained therapeutic benefit. 
      • Assess TCOM with hyperbaric oxygen:
        • If the wound is hypoxic while breathing normobaric air, and a TCOM > 200 mm Hg is achieved breathing hyperbaric oxygen, this is a predictor for success of subsequent HBO for diabetic foot ulcers. This test is 75% accurate. [4] 
        • A minimum TCOM value of 200 mm Hg is necessary to confirm the adequate reversal of wound hypoxia during initial hyperbaric treatment. 
        • In-chamber TCOM values < 100 mm Hg are closely associated with failure of HBO in diabetic foot ulcers (accuracy 89%) However, a trial of HBO continues to be a reasonable approach, if there are no other options for the patient, on a case-by-case basis. A reasonable trial is 15-20 treatments. [4] 
        • If TCOM value does not reach 200 mm Hg upon reaching 2.0 ATA, the chamber pressure should be titrated by .1 ATA every 10 minutes to reach the value of 200 mm Hg but not to exceed 2.5 ATA. 
      • Reassessment after 14 sessions:
        • After 14 HBO sessions, re-evaluate tissue hypoxia with TCOM. Evaluate ulcer responsiveness for healing. If no measurable signs of healing, then reassess for underlying etiology i.e., infection, metabolic, nutritional, vascular, mechanical etc.
        • Continue to 20 treatments if no other complicating factors are identified, then reassess.
      • Reassess after after 20 sessions:
        • If measurable signs of healing are present and periwound TCOM values reach 40 mm Hg, HBO may be paused and ulcer followed for continued healing. 
        •  If measurable signs of healing are present but periwound TCOM values have NOT reached 40 mm Hg, continue HBO daily to 30 treatments and reassess until TCOM values reach 40 mm Hg
      • Wound evaluation weekly and as needed focusing on standard of care and evidence of improvement.
      • Evaluation of tympanic membranes pre HBO and as needed
      • Smoking Cessation

      Follow-Up

      • Continued wound evaluation and management 
      • Maintenance of standard wound therapy as listed above
      • Visual acuity assessment to evaluate for progressive myopia

      Treatment Threshold

      14 – 40 treatments (Utilization review should be requested after 40 treatments)

      Coding

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

      Comments

      • If diabetic, blood sugar should be checked 1 hour prior to treatment and post HBO by unit personnel. 
      • For hyperbaric treatment to continue, re-evaluations must occur at 30-day intervals and must show measurable signs of healing
      Primary Sources: Whelan and Kindwall [5]Weaver [6]National Baromedical Services [7]

      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 [10] [11] 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 [11] calculated the relative risk between intervention and control, and the 2016 SVS-commissioned meta-analysis [10]  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) [12] 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 [10] 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. [13] [14] 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 [11] pooled data of 5 RCTs [12] [14] [15] [16] , 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) [17], the 2016 Wound Healing Society (WHS) [3], the 2012 Wound, Ostomy, and Continence Nurses Society (WOCN) (Wound, Ostomy, and Continence Nurses Society (WOCN) 2012) [18], the 2014 Undersea and Hyperbaric Medicine Society (UHMS)  [19] and the 2017 European Committee for Hyperbaric Medicine (ECHM)  [20] guidelines support the use of HBO as an adjunctive therapy to promote DFU healing and prevent amputation
      Intervention  SVS WHS WOCN UHMS ECHM
      Hyperbaric oxygen therapy as adjunctive therapy to promote DFU healing and reduce amputation rates Grade 2B Level I Level B AHA Class I Grade 2B

      - Observational studies: 

      • A recent longitudinal observational cohort study by Margolis et al [21] 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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      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.

      REFERENCES

      1. CMS. National Coverage Determination (NCD) for Hyperbaric Oxygen Therapy (20.29) . Date of publication 2017;.
      2. Armstrong, David G; Cohen, Kelman; Courric, Stephane; Bharara, Manish; Marston, William et al. Diabetic foot ulcers and vascular insufficiency: our population has changed, but our methods have not. Journal of diabetes science and technology. Date of publication 2011;volume 5(6):1591-1595.
      3. 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;volume 24(1):112-126.
      4. Fife CE, Smart DR, Sheffield PJ, Hopf HW, Hawkins G, Clarke D et al. Transcutaneous oximetry in clinical practice: consensus statements from an expert panel based on evidence. Undersea & hyperbaric medicine : journal of the Undersea and Hyperbaric Medical Society, In.... Date of publication 2009;volume 36(1):43-53.
      5. Harry T. Whelan, Eric Kindwall et al. Hyperbaric Medicine Practice 4th Edition Best Publishing Company. Date of publication 2017;volume fourth():.
      6. Weaver L . "Hyperbaric Oxygen Therapy Indications” Best Publishing Company, North Palm Beach, FL . Date of publication 2014;volume 469(13th Edition,):.
      7. National Baromedical Services. Introduction to Hyperbaric Medicine Primary Training Manual .;.
      8. 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;volume 19(4):731-7.
      9. 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;volume 70(1):21.e1-24; quiz 45.
      10. 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;volume 63(2 Suppl):46S-58S.e1-2.
      11. 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;.
      12. 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;volume 28(2):186-90.
      13. 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;volume 59(3):18-24.
      14. 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;volume 3(1):e9.
      15. 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;volume 26(8):2378-82.
      16. Abidia A, Laden G, Kuhan G, Johnson BF, Wilkinson AR, Renwick PM, Masson EA, McCollum PT et al. The role of hyperbaric oxygen therapy in ischaemic diabetic lower extremity ulcers: a double-blind randomised-controlled trial. European journal of vascular and endovascular surgery : the official journal of the European So.... Date of publication 2003;volume 25(6):513-8.
      17. 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;volume 63(2 Suppl):3S-21S.
      18. 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;volume 40(1):34-45.
      19. Undersea and Hyperbaric Medical Society Hyperbaric Oxygen Committee,, et al. Hyperbaric Oxygen Therapy Indications . Date of publication 2014;.
      20. 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;volume 47(1):24-32.
      21. 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;volume 36(7):1961-1966.
      Topic 129 Version 1.0

      SUBTOPICS