4/16/2016 Adjunct HBO2 Therapy: An Essential Tool For The Care DFUs? ___________________________________________________________ Adjunct HBO 2 Therapy: Fedorko, L., et al., Hyperbaric Oxygen Therapy Does Not Reduce Indications for An Essential Tool Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial. Diabetes Care, For The Care 2016. DFUs March 16, 2016 Margolis, D.J., et al., Lack of effectiveness of hyperbaric oxygen therapy for the treatment of diabetic foot ulcer and the prevention of amputation: a cohort study. William Tettelbach, MD, FACP, FIDSA Diabetes Care, 2013. 36(7): p. 1961-6. System Medical Director of Wound & Hyperbaric Medicine Services Adjunct HBO2 Therapy: An Essential Tool For The Care DFUs? Adjunct HBO2 Therapy: An Essential Tool For The Care DFUs? ___________________________________________________________ ___________________________________________________________ Both these studies have significant shortcomings: Both these studies have significant shortcomings: � Inclusion of Wagner grade 2 DFUs in 46 out of 103 (45%) subjects � Inclusion of Wagner grade 2 DFUs in 46 out of 103 (45%) subjects available for end point adjudication. 1 available for end point adjudication. 1 � Margolis cohort study 2 included Wagner 2 DFUs in 54.3% of the HBO 2 � Margolis cohort study 2 included Wagner 2 DFUs in 54.3% of the HBO 2 group that also showed no benefit of HBO 2 . group that also showed no benefit of HBO 2 . � Including a substantial cohort of patients with Wagner grade 2 DFUs that � Including a substantial cohort of patients with Wagner grade 2 DFUs that do not even meet the indications set by the Undersea & Hyperbaric do not even meet the indications set by the Undersea & Hyperbaric Medical Society unavoidably biases the study’s conclusion toward the Medical Society unavoidably biases the study’s conclusion toward the absence of benefit from HBO 2 therapy . absence of benefit from HBO 2 therapy . Fedorko, L., et al., Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Fedorko, L., et al., Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A 1. 1. Prospective, Double-Blind, Randomized Controlled Clinical Trial. Diabetes Care, 2016. Prospective, Double-Blind, Randomized Controlled Clinical Trial. Diabetes Care, 2016. Margolis, D.J., 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 Margolis, D.J., 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 2. 2. Care, 2013. 36(7): p. 1961-6. Care, 2013. 36(7): p. 1961-6. 1
4/16/2016 Adjunct HBO2 Therapy: An Essential Tool For The Care DFUs? ___________________________________________________________ Other significant shortcomings: � Study’s use of photographic adjudication whether a limb “met the criteria for amputation” rather than the use of actual amputation rates as an outcome measure. 1 � The fact that there may be patients who “met the criteria for major amputation” but who went on to heal undermines the conclusions of this study. Fedorko, L., et al., Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A 1. Prospective, Double-Blind, Randomized Controlled Clinical Trial. Diabetes Care, 2016. Margolis, D.J., 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 2. Care, 2013. 36(7): p. 1961-6. Elements of GRADE ___________________________________________________________ � Clear separation between quality of evidence and strength of recommendations � Explicit evaluation of the importance of outcomes � Explicit and comprehensive criteria for downgrading and upgrading the quality of evidence rating � Transparent system of moving from evidence to recommendations 2
4/16/2016 Diabetic Foot Infections: Treatment 1 Algorithm for the use of HBO 2 2 Wagner Grading System: A. Grade 1: Superficial Diabetic Ulcer B. Grade 2: Ulcer with deep structures involved: • ligament, tendon, joint capsule or fascia no active infection (abscess or osteomyelitis) • C. Grade 3: Ulcer with deep structures involved: • ligament, tendon, joint capsule or fascia + evidence of infection (abscess or osteomyelitis) • D. Grade 4: Gangrene to portion of forefoot E. Grade 5: Extensive gangrene of foot 1. Huang ET et al; UHMS CPG Oversight Committee. A clinical practice guideline for the use of hyperbaric oxygen therapy in the treatment of diabetic foot ulcers. Undersea Hyperb Med. 2015 May-Jun;42(3):205-47. 2. Wagner FW, The diabetic foot. Orthopedics. 1987 Jan;10(1):163-72. 3
4/16/2016 Osteomyelitis ___________________________________________________________ Infected bone is hypoxic * Normal Oxygen Tension (21% O 2 at sea level) � - Healthy Bone = 45 mmHg - Infected Bone = 21 mmHg Hyperbaic Oxygen Tension (100% O 2 at 2 ATA) � - Healthy Bone = 321 mmHg - Infected Bone = 104 mmHg * Rabbit animal model HBO 2 & Antibiotics with Osteomyelitis in Rats Limb Preservation Treatment Network ___________________________________________________________ 10 7 CFU x g -1 of Tibial Bone Control 10 6 HBO Hyperbaric Cefazolin 10 5 Cefazolin + HBO 10 4 10 3 2 wk 4 wk TeleHealth Mendel et al Undersea Hyperb Med 26:169, 1999 4
4/16/2016 Benefits of HBO 2 Adjunct HBO2 Therapy: An Essential Tool For The Care DFUs! ___________________________________________________________ ___________________________________________________________ Tissue oxygen tension restored to > 30 mmHg � required by Neutrophils to destroy bacteria by oxidative killing mechanisms (1,2) - Direct suppressive effect on anaerobic pathogens (3,4) � Augments transport of certain antibiotics across bacterial cell walls � - active transport of antibiotics (e.g. gentamicin, tobramycin, amikacin) across bacterial cell walls does not occur if tissue oxygen tensions are below 20 to 30 mmHg (5) Enhances osteogenesis (6) � Reduces tissue edema (7) � Promotes capillary angiogenesis (8) � � Prevents polymorphonuclear leukocytes from adhering to damaged blood vessel linings - decreases the degree of inflammation which may accompany the surgical treatment of refractory osteomyelitis � Can reduce treatment costs of complicated refractory osteomyelitis by approximately 5x 1987 estimated per case costs reduced from $115,000 to $20,000 (9) - Benefits of HBO 2 : References Adjunct HBO2 Therapy: An Essential Tool For The Care DFUs! ___________________________________________________________ ___________________________________________________________ Hohn DC. Oxygen and leukocyte microbial killing. Davis JC, Hunt TL (eds.), Hyperbaric Oxygen Therapy, 1. Bethesda, Undersea Med. Soc. 1977:101-110. Kindwall EP. Uses of hyperbaric oxygen therapy in the 1990s. Cleve Clin J Med 1992;59: 517-28. 2. Slack WK, Thomas DA, Perrins D. Hyperbaric oxygenation in chronic osteomyelitis. Lancet. 1965;1:1093- 3. 1094. Park MK, Myers RAM, Marzella L. Oxygen tensions and infections: Modulation of microbial growth, activity 4. of antimicrobial agents, and immunologic responses. Clin Infect Dis 1992; 14: 720-740. Verklin RM, Jr, Mandell GL. Alteration of effectiveness of antibiotics by anaerobiosis. J Lab Clin Med. 1977 5. Jan;89(1):65-71. Steed DL. Enhancement of osteogenesis with hyperbaric oxygen therapy. A clinical study. J Dent Res 6. 1982;6IA:288. SkyharMJetal.:Hyperbaric oxygen reduces edema and necrosis of skeletal muscle in compartment 7. syndromes associated with hemorrhagic hypotension. Journal of Bone andJoint Surgery 1986;68A:1218- 1224. Hunt, T.k., Halliday, and D.R. Knighton, Impairment of microbicidal function in wounds: Correction with 8. oxygenation, In Soft and Hard Tissue Repair, T.K Hunt, R.B. Heppenstall, and E. Pines, Editors. 1984, Praeger: New York. p. 455-68. Strauss M.B., Refractory osteomyelitis. Journal of Hyperbaric Medicine 2: 147-159;1987. 9. 5
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