Diabetic Ulcers

Hyperbaric Oxygen Therapy Approval Status

Yes Clearance by US Food and Drug Administration (FDA)

Yes Approval by the Undersea and Hyperbaric Medical Society (UHMS)

About Clearance and Approval


Definition and Causes

Diabetic ulcers are chronic, complex, or problem wounds of the legs and feet in people with diabetes. Diabetic ulcers that fail to heal in three months are usually considered chronic. Some take years to heal or never do.

Wound care specialists classify diabetic foot ulcers using the Wagner Grade Scale:

  • Grade 0: no open lesions, but may possess preulcerative lesions, healed ulcers, presence of bone deformity
  • Grade 1: superficial ulcer, not involving subcutaneous tissue
  • Grade 2: deep ulcer with penetration through the subcutaneous tissue, potentially exposing bone, tendon, ligament, or joint capsule
  • Grade 3: deep ulcer with osteitis (bone inflammation), abscess (pus), or osteomyelitis (bone infection)
  • Grade 4: gangrene of digit (toe)
  • Grade 5: gangrene of foot requiring disarticulation (amputation)

Diabetic ulcers require a healthy, oxygenated wound bed to heal. A lack of sufficient oxygen (hypoxia) in the wound bed slows or stops the normal healing process. Wound healing in people with diabetes is often complicated by poor blood circulation in the feet and legs. Nerve disease (neuropathy) may also cause a loss of sensation in the feet and legs, so even a small cut, sore, or pressure ulcer may go unnoticed for some time and develop into a problem wound. Diabetic ulcers are especially prone to serious bacterial infections that threaten life and limb.

Evidence Index

FDA cleared, widely reimbursed
Strong body of evidence
Repeatedly favorable results
Early or mixed results
Unfavorable or no evidence
Strong evidence against HBOT

Treatment with Hyperbaric Oxygen Therapy

Hyperbaric oxygen therapy (HBOT) is an effective adjunct to traditional wound care therapies, including topical cleaning; surgical removal (debridement) of dead skin and tissue; application of dressings, ointments, and biologics; and use of compression boots or stockings, vacuum or negative pressure wound therapy (NPWT) pumps, ultrasound, laser, and other emerging technologies. HBOT helps repair wounds and enhance healing by improving blood circulation, encouraging the formation of new capillary blood vessels (angiogenesis), supplying more oxygen to tissue in the wound bed, and stimulating the growth and distribution of stem cells. Hyperbaric oxygen also helps kill the anaerobic bacteria that cause some of the worst infections in chronic wounds. Evidence for HBOT is especially strong in diabetic foot ulcers classified Wagner Grade 3 or higher, for which hyperbaric oxygen is widely considered standard therapy.

Read the page Arterial Insufficiencies: Enhancement of Healing in Selected Problem Wounds in the Undersea and Hyperbaric Medical Society resource library to learn more about wound evaluation, hypoxia, measures of wound oxygenation, the mechanisms and efficacy of hyperbaric oxygen, and future areas for research.

In 2016, Diabetes Care, a journal of the American Diabetes Association, reported that a 2015 double-blind, randomized, controlled clinical trial conducted in Canada found “HBOT does not offer an additional advantage to comprehensive wound care in reducing the indication for amputation or facilitating wound healing in patients with chronic DFUs [diabetic foot ulcers].” [ Diabetes Care, 2016 ] The results of this study are in contrast to other clinical trials that did not use a sham placebo as part of their methodology.

HyperbaricLink Commentary

Hyperbaric oxygen plays an increasingly important role in the treatment of problem wounds and limb salvage. But access to accredited hyperbaric facilities and certified hyperbaric physicians and technicians is a public health problem. In 2004 as many as two-thirds of nursing home patients with NPUAP Stage II or worse pressure ulcers were not enrolled in wound care treatment programs [ NCHS, 2011 ]. In diabetes-related wounds alone, US hospitals performed 66,000 toe, foot, and leg amputations in 2006 [ CDC, 2011 ], for which health economists have estimated a cost of $3 billion per year [ ACA, 2008 ].

More and more hospitals and health networks today are opening advanced wound care and hyperbaric centers to serve this unmet clinical need. Even if chronic wounds were its only indicated use, HBOT would be assured a place in evidence-based medicine for quality and cost-effective healthcare.

Patient Resources

HyperbaricLink recommends the following websites for anyone seeking authoritative information, patient advocacy, and community support for diabetic ulcers. See also: Chronic Wounds.

American Diabetes Association

The leading source for diabetes information and support, the American Diabetes Association provides a short Foot Complications page with a helpful “listen to text” button.


A small media empire and growing diabetes community, heavily supported and monitored by drug, device, and insurance companies, dLife has a brief Diabetes Complications: Feet page worth visiting for its extra audiovisual content.  Look for “Video: Feet”.

National Diabetes Information Clearinghouse (NDIC)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
US National Institutes of Health (NIH)

The NDIC presents of wealth of information and statistics about diabetic neuropathy, ulcers, and other complications of diabetes, with easy-to-read educational materials focused on prevention.

WebMD: Diabetic Foot Care

A trusted online source of medical information, WebMD offers an eMedicineHealth section on Diabetic Foot Care that’s authoritative, thorough, and plainly written for general audiences.

Clinical Resources

Start with the following resources to explore current research activities and the peer-reviewed medical literature on hyperbaric oxygen therapy for diabetic ulcers.

 Use the search buttons below to go directly to research on hyperbaric oxygen therapy.

American College of Hyperbaric Medicine (ACHM)

The ACHM is a professional organization working to develop an image of hyperbaric oxygen therapy as a distinct medical specialty, often requiring full-time practice. ACHM has a strong focus on wound care and offers a credentialing and fellowship track for physicians, a Certified Hyperbaric and Wound Specialist (CHWS) program for hyperbaric technologists, and a Wound Care Boot Camp online training course.

ACHM Profile

Association for the Advancement of Wound Care (AAWC)

The preeminent multidisciplinary organization for wound care, AAWC is a nonprofit association open to everyone involved in wound care. Its mission is to spread awareness by promoting excellence in education, clinical practice, public policy, and research.

American Professional Wound Care Association (APWCA)

A nonprofit organization welcoming all wound care professionals, the APWCA combines the structure of a credentialing college and a full-service medical association. Its mission is to decrease the rate of complications from wounds all types. APWCA provides ACHM-recognized physician and technician certification programs in conjunction with the Council for Medical Education and Testing (CMET).

US National Institutes of Health

ClinicalTrials.gov keeps the official list of human clinical trials currently enrolling, in progress, and recently completed. One may reasonably question the size and legitimacy of any study not listed here.

Search ClinicalTrials.gov


An independent, international, nongovernmental organization, the Cochrane Collaboration is a powerful force in evidence-based medicine. One may consider a Cochrane Reviews article on any HBOT topic required hyperbaric reading.

Read the 2015 Cochrane Intervention Review: Hyperbaric oxygen therapy for chronic wounds from the Cochrane Wounds Group, doi:10.1002/14651858.CD004123.pub4

Google Scholar

A specialized Google search engine, Google Scholar indexes scholarly articles, patents, and legal opinions and journals. Google Scholar may produce many search results, but entries provide easy access to full-text journal articles.

Search Google Scholar


HBOEvidence uses computerized tools to appraise the key randomized controlled trials (RCTs) in the hyperbaric medical literature. One may reasonably question the overall strength of HBOT evidence for any disease or condition not covered here.

Search HBOEvidence

US National Library of Medicine, US National Institutes of Health

PubMed keeps the official list of scientific papers published in reputable peer-reviewed medical journals. One may reasonably question the importance and legitimacy of any study not listed here.

Search PubMed.gov

Undersea and Hyperbaric Medical Society

An international nonprofit organization serving some 2,400 members in 50 countries, the UHMS is the chief accrediting body and the primary source of scientific information for diving and hyperbaric medicine physiology.

Read the UHMS statement on the Medicare Arterial Insufficiency ulcer issue.

UHMS Profile


News About Diabetes and Hyperbaric Oxygen Therapy

New Name, Same Day and Time for Monthly Wound Wire Webcast

Tuesday, 6/26

Episode 7 of the highly edutaining Wound Rounds LIVE webcast, newly renamed Wound Wire, airs tomorrow 27 June 2012 at 11 AM Central. Co-hosted by Dr Jeffrey A. Niezgoda and Sharon Baranoski, and powered by WebCME, the free webca read more...

Diabetic Ulcers without Optimal Glycemic Control: New Study Concludes HBOT Should Not Be Delayed

Thursday, 6/7

Physicians treating wounds in patients with diabetes often delay hyperbaric oxygen therapy until the patient has attained optimal blood sugar levels. A new multicenter, prospective cohort study, presented 24 May 2012 in Philadel read more...

More news from O2.0 – the HyperbaricLink blog

Complete diabetes news archive from O2.0 — the HyperbaricLink blog

Further Reading

HyperbaricLink suggests A Leg to Stand On by Oliver Sacks (Summit Books, 1984).

A Leg to Stand On cover


Related Terms

  • Amputation
  • Bedsore
  • Chronic wounds
  • Clostridial myonecrosis
  • Decubitus ulcer
  • Diabetes
  • Gas gangrene
  • Hypoxia
  • Leg ulcer
  • Limb salvage
  • Necrotizing fasciitis
  • Nonhealing wound
  • Osteomyelitis
  • Osteonecrosis
  • Pressure ulcer
  • Selected problem wounds
  • Slow-healing wound
  • Wagner ulcer grade classification scale


Fedorko L, Bowen JM, Jones W, Oreopoulos G, Goeree R, Hopkins RB, O'Reilly DJ. Hyperbaric oxygen therapy does not reduce indications for amputation in patients with diabetes with nonhealing ulcers of the lower limb: a prospective, double-blind, randomized controlled clinical trial.
Diabetes Care, published online before print 06 January 2016. Retrieved 11 January 2016.
doi: 10.2337/dc15-2001
Undersea and Hyperbaric Medical Society, Indications, Problem Wounds. Retrieved 02 May 2015.
WebMD, eMedicineHealth, Diabetic Foot Care. Retrieved 10 June 2011.
Page Data
Updated: 11 Jan 2016 12:00 AM
Created: 20 Jun 2011 12:00 AM
By: About the authors »