Chronic Wounds and Diabetic Foot Ulcers
DDRC Healthcare provides Hyperbaric Oxygen Therapy (HBOT) for selected patients with chronic, non-healing wounds following referral from their treating consultant. HBOT is used as an adjunct to established multidisciplinary wound care and is not a substitute for appropriate surgical, vascular, infectious disease, diabetic, or tissue viability management.
The Role of Oxygen in Wound Healing
Oxygen is essential throughout the wound healing process.
Inflammatory phase
- Supports haemostasis and platelet aggregation
- Facilitates bacterial killing by neutrophils and macrophages
Proliferative phase
- Promotes angiogenesis
- Supports fibroblast activity
- Facilitates collagen synthesis and granulation tissue formation
Remodelling phase
- Supports collagen cross-linking
- Improves extracellular matrix organisation and tensile strength
Many chronic wounds are characterised by local tissue hypoxia resulting from impaired perfusion, infection, inflammation, or a combination of these factors. Persistent tissue hypoxia contributes to delayed healing and increased susceptibility to infection.
Hyperbaric Oxygen Therapy
HBOT involves breathing 100% oxygen under increased atmospheric pressure within a hyperbaric chamber.
The resulting increase in plasma oxygen delivery substantially increases oxygen availability to hypoxic tissues, even when local blood supply is compromised.
Experimental and clinical studies suggest HBOT may:
- Enhance tissue oxygenation
- Stimulate angiogenesis
- Promote collagen synthesis
- Modulate inflammatory responses
- Enhance leukocyte-mediated bacterial killing
- Promote growth factor production
- Support stem cell mobilisation and tissue repair
HBOT is most effective when used alongside gold-standard wound care, including infection management, vascular assessment, pressure off-loading, debridement, and optimisation of diabetes control.
Assessment for Treatment
Not all chronic wounds respond to HBOT.
Careful patient selection is therefore essential.
At DDRC Healthcare, suitability is assessed using:
- Clinical review
- Wound assessment
- Vascular evaluation
- Transcutaneous Oxygen Monitoring (TCOM)
TCOM provides a measure of tissue oxygen delivery and can help determine whether a wound is likely to benefit from hyperbaric treatment.
Diabetic Foot Ulcers
Diabetic foot ulcers remain one of the most widely studied indications for HBOT.
Current international guidelines support consideration of HBOT in selected patients with diabetic foot ulcers, particularly those with more advanced wounds that have failed to respond to optimal multidisciplinary care. HBOT should always be used in conjunction with established diabetic foot management pathways.
Treatment typically consists of up to 40 sessions delivered over approximately eight weeks, depending on clinical response.
Evidence for Hyperbaric Oxygen Therapy in Diabetic Foot Ulcers
Hyperbaric Oxygen Therapy (HBOT) has been investigated for the treatment of diabetic foot ulcers (DFUs) for over three decades. Although the evidence is not entirely uniform, current international guidance supports the use of HBOT in carefully selected patients with chronic, non-healing diabetic foot ulcers that have failed to respond to optimal multidisciplinary management.
HBOT should always be regarded as an adjunctive therapy and not a replacement for standard care. Successful management of diabetic foot ulcers requires appropriate vascular assessment and revascularisation where indicated, infection control, off-loading, debridement, tissue viability input, and optimisation of diabetes management.
International Working Group on the Diabetic Foot (IWGDF) 2023
The International Working Group on the Diabetic Foot (IWGDF) produces one of the most widely respected international guidelines for diabetic foot disease.
Their 2023 recommendation states:
“Consider the use of hyperbaric oxygen as an adjunct therapy in neuro-ischaemic or ischaemic diabetes-related foot ulcers where standard of care alone has failed and where resources already exist to support this intervention.” (Conditional recommendation; Low certainty evidence)
This recommendation reflects an important principle. HBOT is not recommended for every diabetic foot ulcer. Instead, it should be reserved for selected patients with more complex neuro-ischaemic or ischaemic ulcers that have not improved despite optimal standard care. The guideline acknowledges that the available evidence suggests potential benefit, whilst recognising that further high-quality studies are still required.
Undersea and Hyperbaric Medical Society (UHMS) Clinical Practice Guideline
The UHMS guideline remains one of the most influential evidence-based reviews of HBOT for diabetic foot ulcers.
Following systematic review of the literature, the UHMS made the following recommendations:
Wagner Grade 2 or Lower Ulcers
The UHMS suggests against routine use of HBOT in patients with Wagner Grade 2 or lower diabetic foot ulcers because evidence of benefit is insufficient.
Wagner Grade 3 or Higher Ulcers Failing Standard Treatment
For patients with Wagner Grade 3 or greater diabetic foot ulcers that have failed to demonstrate significant improvement after 30 days of optimal treatment, the UHMS recommends consideration of HBOT in addition to standard care to reduce the risk of major amputation and incomplete healing. Evidence was considered moderate in quality.
Post-Surgical and Post-Debridement Ulcers
The guideline also recommends consideration of HBOT following surgical debridement of infected diabetic foot wounds, including situations where bone, deep tissue infection or partial amputation are present. Evidence was again considered moderate in quality.
These recommendations align closely with contemporary UK hyperbaric practice, where careful patient selection remains critical.
Systematic Reviews and Meta-Analyses
Because individual clinical trials have generally been small, systematic reviews and meta-analyses provide some of the most useful evidence regarding the effectiveness of HBOT.
Sharma et al. (2021)
Sharma and colleagues performed a systematic review and meta-analysis of controlled clinical trials examining HBOT for diabetic foot ulcers.
The authors found:
- Improved rates of complete ulcer healing.
- Increased probability of ulcer closure.
- Reduced risk of major amputation in several patient groups.
- Greater effectiveness when HBOT was used as part of a multidisciplinary treatment strategy.
However, the authors also highlighted significant heterogeneity between studies, including differences in ulcer severity, treatment protocols and follow-up periods. They concluded that HBOT appears to be an effective adjunctive therapy, whilst acknowledging the need for additional high-quality trials.
This review is frequently cited because it incorporates both early landmark studies and more recent evidence.
Moreira et al. (2021)
Moreira and colleagues performed a systematic review and meta-analysis restricted to randomised controlled trials.
Eleven randomised trials involving 668 patients were analysed.
Key findings included:
- A significantly lower risk of major amputation amongst patients receiving HBOT.
- Increased likelihood of complete ulcer healing.
- Greater reduction in ulcer size during treatment.
- No demonstrated reduction in minor amputation rates.
Importantly, the authors again noted substantial variation between studies. Whilst the overall results favoured HBOT, confidence in the magnitude of benefit was limited by trial heterogeneity and relatively small sample sizes.
Their conclusion was that HBOT may improve healing outcomes and reduce major amputations when used alongside standard care, but further large multicentre trials are desirable.
The Fedorko Trial (2016)
One of the most influential studies reporting less favourable outcomes for HBOT was published by Fedorko and colleagues in 2016.
This multicentre, double-blind randomised trial concluded that HBOT did not significantly reduce indications for major amputation or improve wound healing compared with placebo treatment.
The study is important because it challenges the positive findings reported by several earlier trials.
However, the trial has generated considerable discussion within the hyperbaric medicine community. Critics have pointed out that:
- The primary endpoint was whether patients met predefined criteria for amputation rather than actual amputation rates.
- Outcomes were assessed using photographic review panels rather than direct clinical decision-making.
- The study experienced challenges with recruitment and treatment completion.
- Some experts have argued that the patient selection process differed from usual clinical practice.
As a result, while the Fedorko study remains an important negative trial, many clinicians view it as one component of a broader and more complex evidence base rather than definitive evidence against HBOT.
Overall Interpretation of the Evidence
The current literature suggests that HBOT may improve healing rates and reduce major amputations in selected patients with advanced diabetic foot ulcers, particularly those with neuro-ischaemic or ischaemic disease that have failed to respond to optimal conventional treatment. Multiple systematic reviews and international guidelines support its use in appropriately selected patients.
At the same time, the evidence remains heterogeneous. Not all studies demonstrate benefit, and HBOT should not be viewed as a universal treatment for all diabetic foot ulcers. Careful patient selection, comprehensive multidisciplinary care and objective assessment of tissue oxygenation remain central to achieving successful outcomes.
References
International Guidelines and Consensus Statements
International Working Group on the Diabetic Foot (IWGDF). Guidelines on the Prevention and Management of Diabetes-Related Foot Disease. 2023. Available from: https://iwgdfguidelines.org.
Huang ET, Mansouri J, Murad MH, Joseph WS, Strauss MB, Tettelbach W, Worth ER. A clinical practice guideline for the use of hyperbaric oxygen therapy in the treatment of diabetic foot ulcers. Undersea and Hyperbaric Medicine. 2015;42(3):205–247.
Undersea and Hyperbaric Medical Society (UHMS). Hyperbaric Oxygen Therapy Indications. 15th Edition. North Palm Beach, FL: Undersea and Hyperbaric Medical Society; 2023.
Mathieu D, Marroni A, Kot J. 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. 2017;47(1):24–32.
Landmark Randomised Controlled Trials
Doctor N, Pandya S, Supe A. Hyperbaric oxygen therapy in diabetic foot. Journal of Postgraduate Medicine. 1992;38(3):112–114.
Faglia E, Favales F, Aldeghi A, Calia P, Quarantiello A, Oriani G, Michael M, Campagnoli P, Morabito A. Adjunctive systemic hyperbaric oxygen therapy in treatment of severe prevalently ischaemic diabetic foot ulcer: a randomised study. Diabetes Care. 1996;19(12):1338–1343.
Abidia A, Laden G, Kuhan G, Johnson BF, Wilkinson AR, Renwick PM, Masson EA, McCollum PT. 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. 2003;25(6):513–518.
Duzgun AP, Satir HZ, Hazar F, Saylam B. Effect of hyperbaric oxygen therapy on healing of diabetic foot ulcers. Journal of Foot and Ankle Surgery. 2008;47(6):515–519.
Kalani M, Jörneskog G, Naderi N, Lind F, Brismar K. Hyperbaric oxygen therapy in treatment of diabetic foot ulcers: long-term follow-up. Journal of Diabetes and its Complications. 2002;16(2):153–158.
Löndahl M, Katzman P, Nilsson A, Hammarlund C. Hyperbaric oxygen therapy as adjunctive treatment of chronic diabetic foot ulcers: a randomised, double-blind, placebo-controlled trial. Diabetes Care. 2010;33(5):998–1003.
Fedorko L, Bowen JM, Jones W, Oreopoulos G, Goeree R, Hopkins RB, O'Reilly D. Hyperbaric oxygen therapy does not reduce indications for amputation in patients with diabetes with non-healing ulcers of the lower limb. Diabetes Care. 2016;39(3):392–399.
Systematic Reviews and Meta-Analyses
Kranke P, Bennett MH, Martyn-St James M, Schnabel A, Debus SE, Weibel S. Hyperbaric oxygen therapy for chronic wounds. Cochrane Database of Systematic Reviews. 2015;(6):CD004123.
Sharma R, Sharma SK, Mudgal SK, Jelly P, Thakur K. Efficacy of hyperbaric oxygen therapy for diabetic foot ulcer: a systematic review and meta-analysis of controlled clinical trials. Scientific Reports. 2021;11:2189.
Moreira D, Cruz D, Oliveira-Pinto J, Mansilha A. The role of hyperbaric oxygen therapy in the treatment of diabetic foot ulcers: a systematic review with meta-analysis of randomised controlled trials on limb amputation and ulcer healing. International Angiology. 2022;41(1):63–73.
Brouwer RJ, Lalieu RC, Hoencamp R, Ubbink DT. Systematic review and meta-analysis of hyperbaric oxygen therapy for diabetic foot ulcers with arterial insufficiency. European Journal of Vascular and Endovascular Surgery. 2020;60(2):280–289.
Golledge J, Singh TP, Moxon JV, Pinchbeck J, Anderson G, Thompson MM, Hinchliffe RJ. Association between hyperbaric oxygen therapy and outcomes in patients with diabetic foot ulcers: a systematic review and meta-analysis. Diabetic Medicine. 2021;38(11):e14585.
Reviews and Evidence Summaries
Bishop A. Hyperbaric oxygen therapy for problem wounds: an update. Wounds UK. 2019;15(4):26–31.
Thom SR. Hyperbaric oxygen – its mechanisms and efficacy. Plastic and Reconstructive Surgery. 2011;127(Suppl 1):131S–141S.
Goldman RJ. Hyperbaric oxygen therapy for wound healing and limb salvage: a systematic review. PM&R. 2009;1(5):471–489.
Kaur S, Pawar M, Banerjee N, Garg R. Evaluation of the efficacy of hyperbaric oxygen therapy in diabetic foot ulcers. Indian Journal of Surgery. 2012;74(3):205–208.