Patrice Muse, ARNP, CWOCN
There are approximately 26 million diabetic people in the United States ?, with a 15% likelihood of developing a foot ulcer ?. Complications of diabetic foot ulcers (DFU) result in linked costs of hospitalization, amputation, rehabilitation, prosthetics, lost wages, long term care, and death 3.
DFU treatment involves a multidisciplinary approach to maximize lower extremity perfusion, manage glycemic control and edema, and offload - frequently using the gold standard of total contact casting. For patients with a Wagner Grade 3 or higher DFU that do not progress after 30 days of standard wound care treatment, the addition of hyperbaric oxygen therapy (HBOT) to a standard regimen can result in significant healing 4 . Standard wound care includes; 1) vascular assessment and correction, 2) nutrition optimization, 3) glucose control, 4) debridement and maintenance of a clean, granular wound bed, 5) off-loading, and 6) treatment to resolve infection 5. National guidelines support the addition of HBOT to reduce risk of amputation and incomplete healing 6. Understanding DFU classifications, HBO physiology, and a knowledge of current literature is helpful in understanding therapy indications.
The Wagner scale categorizes by the depth of tissue involved, the presence and extent of infection, and presence of gangrene. In Grade 0, the skin is intact. A Grade 1 DFU is superficial. Grade 2 reaches tendon, bone or joint capsule. Grade 3 involves deep tissue and osteomyelitis, plantar space abscess, or tendonitis usually with extension along the midfoot compartments of tendon sheaths. Wet or dry gangrene is present in some portion of the toe, toes and/or forefoot in the Grade 4 ulcer. Grade 5 involves gangrene of the whole or a significant part of the foot 7.
HBO therapy specifically treats the primary defects that compromise healing, local tissue hypoxia and infection. By breathing 100% oxygen in an elevated atmospheric pressure, a physiologic increase in the plasma fraction of transported oxygen that is proportional to the increase in pressure available for cellular metabolism occurs. Increased arterial PO2 elevates soft tissue and muscle PO2, and significant levels of hyperoxygenation permit reversal of localized tissue hypoxia 8. Fibroblast replication, collagen synthesis, and neovascularization are enhanced. Leukocyte bactericidal activity increases due to formation of oxygen radicals 9. The angiogenesis in previous hypoxic tissue has also been demonstrated and is thought to occur partially because of induced platelet derived growth factor (PDGF) in the presence of PGDF molecules and vascular endothelial growth factor 10.
Numerous RCTs demonstrate increased healing and decreased costs in limb-salvage outcomes. A Cochrane review analyzed five RCTs that added HBOT to a standard regimen which resulted in significant healing by 6 weeks (RR 2.35; P=0.01) 11. In 2010, Londahl et al 12 studied 94 patients with Wagner 2, 3, or 4 ulcers. The randomized, double-blinded trial compared an HBOT treatment group to the placebo group receiving treatment with hyperbaric air, daily for 40 treatments. 37 patients had complete healing in 1 year of follow-up, 25/48 (52%) in the HBOT group and 12/42 (29%) in the placebo group (P=0.03). A sub-analysis of those patients completing >35 HBOT sessions reported healing in 23/38 (61%) and 10/37 (27%) in the placebo group (P=0.009).
Limb salvage efforts directed to include aggressive modalities including HBO have significant cost-effective implications. In two retrospective cohorts totaling 159 patients, Eggert et.al 13 studied 106 patients in a evidenced-based limb salvage protocol (LSP) for Wagner grade 3 or 4 DFU with intention-to-treat adjunctive HBO therapy. A second cohort of 53 patients had primary lower extremity amputation (LEA) and was not part of the LSP. Ninety-six patients completed the LSP/HBO protocol with average cost totaling $33,100. Eighty-eight of the patients (91.7%) had intact lower extremities at one year. The LEA groups costs ranged from $66,300 to $73,000. Mortality rates were 34% in the LSP cohort and 47.2% in the LEA group.
- Centers for Disease Control and Prevention. (2016). Diabetes. Retrieved from: http://www.cdc.gov/chronic disease/resources/
- Reiber, G.E., Lipsky, B.A.,& Gibbons, G.W. (1998). The burden of diabetic foot ulcers. American Journal of Surgery, 176 (2), 5S-10S.
- Steed, D.L. (2007). Wounds in people with diabetes: assessment, classification, and management. In Krasner, D.L., Rodeheaver, G.T., & Sibbald, R.G. (Eds.), Chronic wound care: A clinical source book for healthcare professionals (pp.537). Malvern, PA: HMP Communications.
- Kranke, P., Bennett, M.H., Martyn-St. James, M., Schnabel, A., Debus, S.E., & Weibel, S. Hyperbaric oxygen therapy for chronic wounds. Cochrane Database System Rev. 2012;4:CD004123.
- First Coast Service Options. (2016, July 5). LCD - Hyperbaric Oxygen Therapy. Retrieved from: http://medicare.feso.com/Fee_lookup/LCDdisplay.asp?id=L36504
- U.S. Department of Health & Human Services, Agency for Healthcare Research & Quality (2015). A clinical practice guideline for the use of hyperbaric oxygen therapy in the treatment of diabetic foot ulcers. NGC:010736). Retrieved from: https://guideline.gov/summaries/summary/49353/b
- Niezgoda, J.A., Matos, L.A. (1994) Hyperbaric oxygen in the management of the diabetic foot ulcer. In Kindwall, E.P., Whelan, H.T. (Eds.), Hyperbaric medicine practice. Flagstaff, AZ.:Best Publishing Company.
- Warriner, R.A., & Beard, T. (2007). The role of the hyperbaric medicine team in chronic wound care. In Krasner, D.L., Rodeheaver, G.T., & Sibbald, R.G. (Eds.), Chronic wound care: A clinical source book for healthcare professionals (pp.396-398). Malvern, PA: HMP Communications.
- Niezgoda, J.A., Matos, L.A. (1994) Hyperbaric oxygen in the management of the diabetic foot ulcer. In Kindwall, E.P., Whelan, H.T. (Eds.), Hyperbaric medicine practice. Flagstaff, AZ.:Best Publishing Company.
- Bonomo, S.R., Davidson, J.D., Yu, Y., Xia, Y., Lin, X., & Mustoe, T.A. (1998). Hyperbaric oxygen as a signal transducer: upregulation of platelet derived growth-factor-beta receptor in the presence of HBO2 and PDGF. Undersea Hyperbaric Medicine, (25)4,211-216.
- Kranke ......
- Londahl, M., Katzman, P., Nilsson, A., & Hammarlund, C. (2010). Hyperbaric oxygen therapy facilitates healing of chronic foot ulcers in patients with diabetes. Diabetes Care, 33(5), 998-1003.
- Eggert, J.V., Worth, E.R., & Van Gils, C.C. (2016). Cost and mortality data of a regional limb salvage and hyperbaric medicine program for wagner grade 3 or 4 diabetic foot ulcers. Undersea Hyperbaric Medicine, 43(1), 1-8.