Point-Counterpoint: HBOT: Is It Worthwhile For DFUs?

Author(s): 
Enoch T. Huang, MD, MPH&TM, FACEP, FUHMS, FACCWS, and Javier La Fontaine, DPM, MS, FACFAS, FASPS

Yes.

This author offers a closer examination of recent controversies in the literature on hyperbaric oxygen therapy (HBOT) and cites an ample body of literature to justify that HBOT can be a valuable treatment to promote diabetic foot ulcer healing in appropriately selected patients.

By Enoch T. Huang, MD, MPH&TM, FACEP, FUHMS, FACCWS

Clinicians have debated the use of hyperbaric oxygen therapy (HBOT) for the treatment of diabetic foot ulcers (DFUs) for years. When looking at the entire body of evidence, there have been eight randomized controlled trials, over a dozen observational studies and several meta-analyses that have shown to varying degrees that HBOT increases the rate and percentages of wound healing, decreases amputation rates, stimulates angiogenesis, increases healthcare-related quality of life, and helps in the overall treatment of DFUs.1-26

   Supporters and detractors of HBOT have their own biases when looking at the literature, but both camps can agree on the huge public health problem that is associated with DFUs.

   The Centers for Disease Control and Prevention (CDC) estimate that 25.8 million people, or roughly 8.3 percent of the U.S. population, are affected by diabetes.27 More than 60 percent of non-traumatic amputations occur in people with diabetes and a foot ulcer precedes 85 percent of lower-limb amputations in patients with diabetes. Contralateral leg amputation occurs in 56 percent of patients with diabetes who have had a lower-limb amputation and the five-year mortality rate for patients with diabetes who have had a single-leg amputation is 60 percent. That is higher than the mortality rate of breast cancer (10 percent), bladder cancer (19 percent), colorectal cancer (33 percent) and all cancers combined (32 percent).28,29 While the amputation itself is not the cause of the high five-year mortality, it is an indicator that this particular patient has advanced disease with a host of comorbidities.

   Will HBOT reverse these comorbidities and decrease this high mortality rate? No. However, that does not mean that HBOT has no role in improving healthcare quality of life by preserving a functioning limb.

   Researchers have shown that the use of comprehensive foot care programs — that include early screening and evaluation of problems, foot care education, preventive therapy, and referral to specialists — reduce amputation rates by 45 to 85 percent.27 Hyperbaric oxygen should be an integral part of a comprehensive foot care program and a preponderance of the literature supports this as well.

   The biggest caveat to using HBOT is that it is an adjunctive treatment and cannot take the place of high quality wound care. The International Working Group on the Diabetic Foot guidelines for the best practice treatment of diabetic foot ulcers includes four tenets: treatment of underlying infection, revascularization if appropriate and feasible, offloading to minimize trauma to the ulcer site, and management of the wound bed to promote healing.30 Failure to address these tenets obviates any discussion about the utility of HBOT.

Assessing The Benefits Of HBOT And Discordance With CMS Reimbursement Policies

What exactly does HBOT do for the diabetic foot? HBOT is capable of oxygenating ischemic and hypoxic tissue, stimulating angiogenesis, mobilizing stem cells, up-regulating a plethora of growth factors, stimulating fibroblast and osteoclast activity, increasing collagen synthesis and cross-linking, reducing edema, increasing red blood cell deformability, and enhancing leukocyte killing activity. In short, HBOT improves wound healing.31

   Patients are incapable of supersaturating the hemoglobin in their blood, even when breathing 100% oxygen. Under hyperbaric conditions, however, the plasma that normally has an insignificant amount of dissolved oxygen is now saturated with enough oxygen to support the body’s metabolic needs even in the absence of all hemoglobin.32 For a patient who has diabetes and concomitant atherosclerosis with microvascular disease, the use of HBOT permits oxygen to flow past areas of critical stenosis and reach areas of previously ischemic tissue, allowing for the natural wound healing process to resume.

   In 2003, the Centers for Medicare and Medicaid Services (CMS) determined reimbursement policies for HBOT with regard to diabetic foot ulcers based on a single, pivotal randomized controlled trial (RCT) that assessed hospitalized patients with serious foot infections (e.g., Wagner Grade 3 and 4 DFUs).4 This study showed patients benefited from HBOT when clinicians used it in conjunction with aggressive surgical management of the wound, offloading of the foot, aggressive management of diabetes using intravenous insulin, culture-driven antibiotic therapy to eradicate infection, and aggressive revascularization of patients with peripheral arterial disease.

   While the CMS decision has been critical with regard to the financial viability of using HBOT for diabetic foot ulcers, it has created discordance between what the science has shown to work and what the government is willing to pay to treat. The CMS criteria state that any patients who have a diabetic foot wound can receive HBOT if they have a Wagner 3 or greater stage ulcer and have not had any measurable signs of healing for 30 days of standard wound therapy.30 The original study focused on the acute dysvascular foot while CMS indications focus on outpatient, chronic diabetic foot ulcers. This disconnect has been the source of consternation for clinicians who feel like they are forcing a square peg in a round hole when treating their patients.

A Closer Look At Recent Controversies In The Literature On HBOT

A recent retrospective review concluded that HBOT did not improve the likelihood that a wound would heal and did not decrease the chance of an amputation.34 The authors analyzed data from a large national database in the hopes of proving that HBOT provided a significant reduction in amputations and improved healing rates. What they found was a surprise to say the least and researchers have directed many criticisms at these authors for their methodology and conclusions.35-39

   For me, however, the takeaway lesson was that this effectiveness study showed that HBOT, as practiced in a real-world, for-profit setting, did not reflect the results of prior efficacy studies that used much more rigid inclusion and exclusion criteria.

   While the criteria listed in the CMS guidelines for standard wound therapy mirror best practice recommendations, it depends on each individual practitioner to apply the highest amount of rigor when addressing them. The bigger issue, though, is the shifting interpretation of the Wagner scale to the stable outpatient diabetic foot ulcer.

   Strauss provides an informative history of the now all-important Wagner scale and its modifications by the hyperbaric community over the years.40 As Strauss states, “the Grade III wound as Wagner classified it (i.e., systemic sepsis caused by a deep abscess and/or osteomyelitis and requiring in-hospital management including immediate debridement, IV antibiotics, and medical/diabetic management) is far different than the criteria used for outpatient HBO management of (diabetic foot wounds).”

   Ironically, CMS’s decision to pay for outpatient-only use of HBOT may have resulted in a double whammy of excessive treatment for patients who would not benefit and denial of treatment for patients who would benefit. In clinical practice, I have been frustrated more often than not that payment policies prevent me from treating the hospitalized patient with a gangrenous foot that requires incision and drainage, or partial foot amputation, such as a transmetatarsal amputation or ray resection. Postoperative transmetatarsal amputation failures are high in patients with diabetes and ischemia, suggesting that this would be an ideal population to use HBOT for limb salvage. However, this would not be considered an appropriate patient population using CMS guidelines.41,42 This leaves physicians trying to find alternative diagnoses that they can use to justify HBOT rather than letting their patients go untreated.

   Does this mean that we should only use HBOT on admitted patients who are getting aggressive debridement? The answer is no. Recent double-blinded RCTs using the CMS guidelines that dictate a waiting period before HBOT therapy showed an increased percentage of healed patients in the HBOT group and one study showed that for every four patients treated with HBOT, physicians averted one non-healing ulcer.1,7

   Further support for the use of HBOT for diabetic foot ulcers comes from meta-analyses published in non-hyperbaric journals. The Cochrane Report concluded that “HBOT seems to improve the chance of healing diabetes-related foot ulcers and may reduce the number of major amputations in people with diabetes who have chronic foot ulcers.”23 The Infectious Diseases Society of America (IDSA) gave HBOT a strong recommendation with moderate evidence with regard to wound healing but not for resolving infection.43 All of this has led some critics of HBOT to reconsider their stance.44

Determining The Selection Criteria For HBOT

Given the evidence demonstrating that HBOT is an efficacious treatment, the biggest hurdle is determining the proper selection criteria for patients for whom HBOT will be of benefit. Studies of large groups of patients receiving HBOT have shown this is easier said than done. Transcutaneous oxygen monitoring (TCOM) has been a useful tool in predicting success or failure with HBOT, but baseline TCOM is not as useful as measuring TCOM response to hyperbaric exposure.12,13,20,45,46 Other factors that have been linked to outcome in DFUs are renal failure, pack-year smoking history and the number of HBOT sessions completed although none of these can reliably predict who will respond and who will not.10,12

   Future research needs to elucidate screening criteria that will help segregate patients into three groups: those who will reliably heal without HBOT; those who are unlikely to heal with HBOT; and those who remain candidates for HBOT. Until then, a combination of clinical experience, transcutaneous oximetry and incorporation into a comprehensive wound care program remains the best option with regard to patient selection for HBOT.

   Dr. Huang is the Medical Director of Wound Healing and Hyperbaric Medicine at Adventist Medical Center in Portland, Ore. He is an Affiliate Assistant Professor of Emergency Medicine at Oregon Health and Science University in Portland, Ore. He is also an Assistant Clinical Professor of Emergency Medicine at the Western University of Health Sciences in Pomona, Calif.

References

1. 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(6):513-8.
2. Doctor N, Pandya S, Supe A. Hyperbaric oxygen therapy in diabetic foot. J Postgrad Med. 1992; 38(3):112-4, 111.
3. Duzgun AP, Satir HZ, Ozozan O, et al. Effect of hyperbaric oxygen therapy on healing of diabetic foot ulcers. J Foot Ankle Surg. 2008; 47(6):515-9.
4. Faglia E, Favales F, Aldeghi A, et al. Adjunctive systemic hyperbaric oxygen therapy in treatment of severe prevalently ischemic diabetic foot ulcer. A randomized study. Diabetes Care. 1996; 19(12):1338-43.
5. Kessler L, Bilbault P, Ortega F, et al. Hyperbaric oxygenation accelerates the healing rate of nonischemic chronic diabetic foot ulcers: a prospective randomized study. Diabetes Care. 2003; 26(8):2378-82.
6. Lin T, Chen S, Niu K. The vascular effects of hyperbaric oxygen therapy in treatment of early diabetic foot. Undersea Hyperb Med. 2001; 28(Suppl):67.
7. Londahl M, Katzman P, Nilsson A, Hammarlund C. Hyperbaric oxygen therapy facilitates healing of chronic foot ulcers in patients with diabetes. Diabetes Care. 2010; 33(5):998-1003.
8. Ma L, Li P, Shi Z, 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 Manage. 2013; 59(3):18-24.
9. Baroni G, Porro T, Faglia E, et al. Hyperbaric oxygen in diabetic gangrene treatment. Diabetes Care. 1987; 10(1):81-6.
10. Chen CE, Ko JY, Fong CY, Juhn RJ. Treatment of diabetic foot infection with hyperbaric oxygen therapy. Foot Ankle Surg. 2010; 16(2):91-5.
11. Faglia E, Favales F, Aldeghi A, et al. Change in major amputation rate in a center dedicated to diabetic foot care during the 1980s: prognostic determinants for major amputation. J Diabetes Complications. 1998; 12(2):96-102.
12. Fife CE, Buyukcakir C, Otto G, et al. Factors influencing the outcome of lower-extremity diabetic ulcers treated with hyperbaric oxygen therapy. Wound Repair Regen. 2007; 15(3):322-31.
13. Fife CE, Buyukcakir C, Otto G, et al. The predictive value of transcutaneous oxygen tension measurement in diabetic lower extremity ulcers treated with hyperbaric oxygen therapy: a retrospective analysis of 1,144 patients. Wound Repair Regen. 2002; 10(4):198-207.
14. Hart GB, Strauss MB. Responses of ischaemic ulcerative conditions to OHP. Proceedings of the Sixth International Congress on Hyperbaric Medicine. 1979; 312-314.
15. Kalani M, Jorneskog G, Naderi N, et al. Hyperbaric oxygen (HBO) therapy in treatment of diabetic foot ulcers. Long-term follow-up. J Diabetes Complications. 2002; 16(2):153-8.
16. Oriani G, Meazza D, Favales F, et al. Hyperbaric oxygen therapy in diabetic gangrene. J Hyperbar Med. 1990; 5(3):171-175.
17. Oriani G. Diabetic foot and hyperbaric oxygen therapy: a ten-year experience. Journal of Hyperbaric Medicine. 1992; 7(4):213-221.
18. Strauss MB. The effect of hyperbaric oxygen in crush injuries and skeletal muscle-compartment syndromes. Undersea Hyperb Med. 2012; 39(4):847-55.
19. Wattel F, Mathieu D, Coget JM, Billard V. Hyperbaric oxygen therapy in chronic vascular wound management. Angiology. 1990; 41(1):59-65.
20. Wattel F. Hyperbaric oxygen in the treatment of diabetic foot lesions: search for predictive healing factors. J Hyperbaric Med. 1991; 6(4):263-268.
21. Zamboni WA, Wong HP, Stephenson LL, Pfeifer MA. Evaluation of hyperbaric oxygen for diabetic wounds: a prospective study. Undersea Hyperb Med. 1997; 24(3):175-9.
22. Game FL, Hinchliffe RJ, Apelqvist J, et al. A systematic review of interventions to enhance the healing of chronic ulcers of the foot in diabetes. Diabetes Metab Res Rev. 2012; 28(Suppl):119-41.
23. Kranke P, Bennett MH, Martyn-St. James M, et al. Hyperbaric oxygen therapy for chronic wounds. Cochrane Database Syst Rev. 2012; 4:CD004123.
24. 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 Proc. 2013; 88(2):166-75.
25. Murad MH, Altayar O, Bennett M, et al. Using GRADE for evaluating the quality of evidence in hyperbaric oxygen therapy clarifies evidence limitations. J Clin Epidemiol. 2014; 67(1):65-72.
26. Londahl M, Landin-Olsson M, Katzman P. Hyperbaric oxygen therapy improves health-related quality of life in patients with diabetes and chronic foot ulcer. Diabet Med. 2011; 28(2):186-90.
27. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States. 2011, U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Atlanta, GA.
28. Cowie CC. Diabetes: 1996 Vital Statistics. 1996, University of Michigan: American Diabetes Association.
29. NIH Cancer Fact Sheet. 2010, National Institute of Health. Available at http://report.nih.gov/nihfactsheets/viewfactsheet.aspx?csid=75 .
30. Game FL, Hinchliffe RJ, Apelqvist J, et al. Specific guidelines on wound and wound-bed management 2011. Diabetes Metab Res Rev. 2012; 28(Suppl 1):232-3.
31. Thom SR. Hyperbaric oxygen: its mechanisms and efficacy. Plast Reconstr Surg. 2011; 127(Suppl 1):131S-141S.
32. Boerema I, Meyne NG, Brummelkamp WH, et al. Life without blood. J Cardiovasc Surg. 1960; 182:133-146.
33. National Coverage Determination (NCD) for Hyperbaric Oxygen Therapy (20.29), in Hyperbaric Oxygen Therapy. 2006, Centers for Medicare and Medicaid Services.
34. Margolis DJ, Gupta J, Hoffstad O, 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. 2013; 36(7):1961-6.
35. Carter MJ, Fife CE, Bennett M. Comment on: Margolis 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. 2013; 36:1961-1966. Diabetes Care. 2013; 36(8):e131.
36. Hawkins GC. Comment on: Margolis 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. 2013;36:1961-1966. Diabetes Care. 2013; 36(8):e129.
37. Londahl M, Katzman P. Comments on Margolis et al. Lack of effectiveness of hyperbaric oxygen therapy for the treatment of diabetic foot ulcer and the prevention of amputation. Int Wound J, 2013, epub ahead of print.
38. Margolis DJ, Gupta J, Hoffstad O, et al. Response to Comments on: Margolis 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. 2013;36:1961-1966. Diabetes Care. 2013. 36(8): p. e132-3.
39. Sherlock S. Comment on: Margolis 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. 2013;36:1961-1966. Diabetes Care. 2013; 36(8):e130.
40. Strauss MB. The Wagner wound grading system. Wound Care & Hyperbaric Medicine. 2012; 3(4):38-45.
41. Hosch J, Quiroga C, Bosma J, et al. Outcomes of transmetatarsal amputations in patients with diabetes mellitus. J Foot Ankle Surg. 1997; 36(6):430-4.
42. Pollard J, Hamilton GA, Rush SM, Ford LA. Mortality and morbidity after transmetatarsal amputation: retrospective review of 101 cases. J Foot Ankle Surg. 2006; 45(2):91-7.
43. Lipsky BA, Berendt AR, Corina PB, et al. 2012 infectious diseases society of america clinical practice guideline for the diagnosis and treatment of diabetic foot infections. J Am Podiatr Med Assoc. 2013; 103(1):2-7.
44. Lipsky BA, Berendt AR. Hyperbaric oxygen therapy for diabetic foot wounds: has hope hurdled hype? Diabetes Care. 2010; 33(5):1143-5.
45. Strauss MB, Bryant BJ, Hart GB. Transcutaneous oxygen measurements under hyperbaric oxygen conditions as a predictor for healing of problem wounds. Foot Ankle Int. 2002; 23(10):933-7.
46. Londahl M, Katzman P, Hammarlund C, et al. Relationship between ulcer healing after hyperbaric oxygen therapy and transcutaneous oximetry, toe blood pressure and ankle-brachial index in patients with diabetes and chronic foot ulcers. Diabetologia. 2011; 54(1):65-8.

   For further reading, see “How Effective Is HBOT For Diabetic Foot Ulcers?” in the May 2013 issue of Podiatry Today. To access the archives, visit www.podiatrytoday.com.

No.

This author points to conflicting results in the literature on HBOT and the fact that only a few randomized controlled trials involving humans have examined HBOT in relation to treatment for diabetic foot ulcers. He says there is also a need for more specific criteria in regard to HBOT for patients with diabetic foot ulcers.

By Javier La Fontaine, DPM, MS, FACFAS, FASPS

The clinical history of hyperbaric medicine dates back to the 17th century but its benefits for wound healing and infection did not appear in the medical literature until the 1960s. A report by the Hyperbaric Oxygen Therapy Committee of the Undersea and Hyperbaric Medical Society lists several indications for hyperbaric oxygen therapy (HBOT) that are directly applicable to lower extremity pathology.1 These include clostridial myonecrosis, acute traumatic ischemia, enhancement of healing in problem wounds, necrotizing soft tissue infections, refractory osteomyelitis, compromised skin grafts and flaps, and thermal burns.

   Although HBOT has gained popularity as an adjunctive treatment for diabetic foot wounds, there are surprisingly few published reports that support its efficacy. Only a few randomized, controlled clinical trials involving human patients exist on the use of HBOT for the treatment of these conditions. Two meta-analyses have also examined the subject.

   Furthermore, there seem to be no objective measures to assist clinicians in appropriately selecting patients for HBOT. More than half of the published research reports dealing with HBOT for diabetic foot disease originated from a group of researchers at the Center of Diabetology and Metabolic Diseases at Niguarda Hospital, and the Department of Anesthesia and Hyperbaric Medicine at Galeazzi Institute in Milan, Italy.2-5

What The Research Does Reveal

The most convincing work in the medical literature to date demonstrates that HBOT can reduce the number of major amputations in patients with Wagner grade IV wounds.6 Even these results should receive re-evaluation in a larger multicenter trial in which researchers can control many of the potential confounding factors or evaluate the factors in the model. The study authors’ anecdotal experience is that HBOT is in common use as an adjunct to standard wound care in many types of wounds, deep and superficial, infected and non-infected, ischemic and well-perfused.

   Hyperbaric wound care centers often use the TcPO2 response to 100% oxygen challenge as a criterion to determine if the wound would benefit from HBOT.7 Given the relatively high cost of this treatment modality, perhaps a more acute awareness of the medical literature would reduce the economic burden that HBOT places on entities that are financially at risk for patient care.

   There are three randomized control trials from 1987 until 2011. Most of these clinical trials compare HBOT to standard of care with debridement, dressing changes, etc., with the exception of the study by Londahl and colleagues in 2010.8 The aim of this study was to evaluate the effect of HBOT in the management of chronic diabetic foot ulcers. The study was a randomized, single-center, double-blinded, placebo-controlled clinical trial. The authors compared outcomes for the group receiving HBOT with those of the group receiving treatment with hyperbaric air (sham). Treatments occurred in a multi-place hyperbaric chamber for 85 minutes daily, five days a week for eight weeks (40 treatment sessions).

   The authors studied 94 patients with Wagner grade 2, 3 or 4 ulcers, which had been present for more than three months.8 In the intention-to-treat analysis, complete healing of the index ulcer occurred in 37 patients at one year of follow-up: 25/48 (52 percent) in the HBOT group and 12/42 (29 percent) in the placebo group. In a sub-analysis of those patients completing more than 35 HBOT sessions, healing of the index ulcer occurred in 23/38 (61 percent) in the HBOT group and 10/37 (27 percent) in the placebo group. The study authors concluded that adjunctive treatment with HBOT facilitates healing of chronic foot ulcers in selected patients with diabetes. However, it is clear that healing 52 percent of the ulcers in one year does not compare to other studied treatment modalities that use 12 and 20 weeks as the goal for time to heal.

   Currently, the highest medical evidence are two meta-analyses, one systematic review and a pragmatic type study. In 2012, an RCT-based meta-analysis focused on the efficacy of HBOT.9 The authors found seven RCTs of 369 subjects that evaluated the efficacy of HBOT in comparison with conventional therapy. Hyperbaric therapy varied from 2 to 3 atm for 45 to 120 min, administered once or twice per day, four to five times per week. The case definition for diabetic foot ulcer varied across studies but mostly included wounds below the ankle in individuals with diabetes. The wound grade varied from Wagner grade 0 to 4 with most studies including individuals with grade 2 wounds and allowing individuals with poor lower extremity arterial blood flow. The conventional therapy arm also varied by trial but usually involved offloading the foot.

   The results did not show an advantage of HBOT in comparison with standard therapy with respect to a healed wound at six months or one year.9 In five trials with a total of 309 patients, the authors also were not able to show fewer amputations, fewer minor amputations or fewer major amputations in those who received HBOT in comparison with standard therapy. Although the study could not show a statistically significant advantage, in most circumstances, HBOT appeared to be superior to conventional therapy.

A Closer Look At Two Studies That Cast Doubt On HBOT

In a more pragmatic type study, Margolis and colleagues studied 6,259 individuals with diabetes, adequate lower limb arterial perfusion and foot ulcer extending through the dermis, representing 767,060 person-days of wound care.10 In the propensity score–adjusted models, individuals receiving HBOT were less likely to have healing of their foot ulcer and more likely to have an amputation. Additional analyses, including the use of an instrumental variable, assessed the robustness of the results to unmeasured confounding factors. Hyperbaric oxygen did not improve the likelihood that a wound might heal or decrease the likelihood of amputation in any of these analyses.

   In 2013, a systematic review assessed the efficacy and safety of HBOT as adjunctive treatment for diabetic foot ulcers.7 The authors found 13 trials (a total of 624 patients), including seven prospective randomized trials. In regard to short-term healing of diabetic foot ulcers, the overall pooled data revealed a statistically significant beneficial effect in HBOT-treated cases but there was a great deal of heterogeneity. Eleven trials assessed the impact of HBOT in preventing major amputation. The study authors found there were significantly fewer major amputations in patients undergoing HBOT in comparison to those receiving conventional therapy without HBOT. The study authors detected no heterogeneity.

   Five trials, including four RCTs, provided data on minor amputations distal to the ankle joint with outcome assessment for up to 55 months. Pooled analysis of these data resulted in a relative risk of 1.24, revealing identical minor amputation rates between HBOT and conventional therapy, and no evidence to suggest statistical heterogeneity.7 Pooling analysis revealed that, in comparison to treatment without HBOT, adjunctive treatment with HBOT resulted in a significantly higher proportion of healed diabetic ulcers. The analysis also revealed that treatment with HBOT was associated with a significant reduction in the risk of major amputations but had no effect on the rate of minor amputations. The authors concluded that treatment with HBOT improved the rate of healing and reduced the risk of major amputations in patients with diabetic foot ulcers.

In Conclusion

After evaluating the medical literature supporting HBOT as an adjunctive treatment for diabetic foot wounds, I can conclude that additional research is needed to define the specific indications and benefits of this treatment modality. Unfortunately, the literature on the efficacy of HBOT is still not clear. There have been no studies of the effectiveness of this therapy. The importance of effectiveness studies on therapies for the treatment of diabetic foot ulcers is critical.

   Therapies such as skin substitutes, acellular dermal matrices and offloading modalities have had extensive study with a high level of well-designed studies. The true RCT that compared HBOT treatment with a sham showed positive results at one year. The two meta-analyses still showed conflicting results. Therefore, long-term studies with the sham control are still needed to show the effectiveness of HBOT.

   Dr. La Fontaine is the Associate Professor of the Department of Plastic Surgery at the University of Texas Southwestern Medical Center in Dallas. He is a Fellow of the American College of Foot and Ankle Surgeons, and the American Society of Podiatric Surgeons.

References
1. Camporesi EM (editor). Hyperbaric Oxygen Therapy Committee Report. Undersea and Hyperbaric Medical Society, Kensington, MD, 1996.
2. Faglia E, Favales F, Aldeghi A, et al. Adjunctive systemic hyperbaric oxygen therapy in treatment of severe prevalently ischemic diabetic foot ulcer. Diabetes Care. 1996;19(12):1338-1343.
3. Baroni G, Porro T, Faglia E, et al. Hyperbaric oxygen in diabetic gangrene treatment. Diabetes Care. 1987;10(1):81-86.
4. Oriani G, Meazza D, Favales F, et al. Hyperbaric oxygen therapy in diabetic gangrene. J Hyperb Med. 1990;5(3):171-175.
5. Oriani G, Michael M, Meazza D, et al. Diabetic foot and hyperbaric oxygen therapy: a ten-year experience. J Hyperb Med. 1992;7(3):213-221.
6. Wattel F, Mathieu D, Coget JM, Billard V. Hyperbaric oxygen therapy in chronic vascular wound management. Angiology. 1990;41(1):59-65.
7. Liu R, Li L, Yang M, Boden G, Yang G. Systematic review of the effectiveness of hyperbaric oxygenation therapy in the management of chronic diabetic foot ulcers. Mayo Clin Proc. 2013;88(2):166-175.
8. Löndahl M, Katzman P, Nilsson A, Hammarlund C. Hyperbaric oxygen therapy facilitates healing of chronic foot ulcers in patients with diabetes. Diabetes Care. 2010 May;33(5):998-1003.
9. Kranke P, Bennett MH, Martyn-St James M, Debus SE. Hyperbaric oxygen therapy for chronic wounds. Cochrane Database Syst Rev. 2012 10.1002/14651858. CD004123.pub3.
10. Margolis DJ, Gupta J, Hoffstad O, Papdpopoulus M, Glick HA, Thom SR, Mitra N. Lack of effectiveness of hyperbaric oxygen therapy for the treatment of diabetic foot ulcer and the prevention of amputation. Diabetes Care. 2013; 36(7):1961–1966.

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