Thousands of diabetic foot ulcer patients could benefit from topical oxygen therapy with updated treatment pathway

• Expert Panel Report recommends updated algorithm for the use of topical oxygen therapy which could help the estimated 169,000 UK patients with diabetic foot ulcers¹

• Topical oxygen therapy is recommended as an adjunct to standard of care if non-healing is apparent after four weeks

• Topical oxygen therapy is also recommended for early use (<4 weeks) consideration in patients with complications or co-morbidities such as peripheral arterial disease or ulcer pain, where faster wound healing would present benefit to patient outcomes

 

19 June 2019, Milton Keynes, UK. A new Expert Panel Report², published in The Diabetic Foot Journal, recommends a new treatment algorithm for topical oxygen therapy in patients with diabetic foot ulcers (DFU). The new treatment algorithm recommends that topical oxygen therapy is considered as an adjunct to standard of care after four weeks if the wound area has not reduced by 40%. In addition, it recommends that early initiation (<4 weeks) of topical oxygen therapy could be beneficial for patients where peripheral arterial disease (PAD) is present, where there is ulcer pain, non-healing after amputation, or sloughy wounds.

There are approximately 169,000 people with a DFU in the UK,¹ with nearly 65% complicated by PAD,³ presenting a treatment challenge. The Expert Panel Report states that advanced treatment options are needed as healing rates under standard-of-care are often poor.⁴ Oxygen is known to be essential for wound healing.² Sustained delivery of oxygen, either from the blood supply or applied from an external source such as topical oxygen, is vital to heal non-healing wounds, especially for DFUs, often complicated by PAD.⁵

Paul Chadwick, Visiting Professor at Birmingham City University and chair of the Expert Panel Report, commented: “The evidence for topical oxygen therapy is growing and is shown to be beneficial and improve outcomes in suitable patients. This new consensus document and simple treatment pathway provides clarity on the role of topical oxygen therapy and when it should be introduced to help manage and heal these difficult to heal wounds. The patients of biggest concern for me are those with severe ulcers as they are four times more likely to need a major amputation and almost twice as likely to die within one year.”

One product showing promising results in topical oxygen therapy is Granulox^® (Mölnlycke)^, a haemoglobin spray that binds oxygen from the atmosphere and transports it to the wound bed, where it is released.

A European Wound Management Association (EWMA) evaluation of the currently available oxygen therapies in wound care awarded the haemoglobin spray a treatment recommendation of Grade 1B, indicating a positive benefit–risk value with moderate quality of evidence and very strong observational studies.⁶

In a single-blinded randomised controlled trial on 72 patients with venous leg ulcers, the average wound size reduction was 53% at 13 weeks (p<0.01) in the group treated with the haemoglobin spray. No statistically significant reduction in wound size was seen in the control group.⁷ Several studies have shown a reduction in DFU size when haemoglobin spray is used as an adjunct to standard care.^8,9,10

Studies have also shown that twice as many chronic wounds healed at 8–16 weeks with the haemoglobin spray compared to standard of care,^10,11,12 with shorter time (50%) to heal.¹² More than 70% of patients have reported lower average pain scores at four weeks with the haemoglobin spray than with standard of care in chronic wounds,¹⁰ and 99% have shown less slough in chronic wounds after four weeks compared to 33% with standard of care.¹³

The Expert Panel report advises that initiation of topical oxygen therapy for the treatment of DFUs should be undertaken by the multidisciplinary foot care service or a clinician experienced in diabetic foot care; it can then be continued in the community.

Diabetic foot disease is the largest single reason for hospital admissions among people with diabetes.¹⁴ DFUs cost the NHS an estimated £1 billion per year,^15,16 while the additional social costs to the patient, such as reduced mobility and sickness absence, are estimated at £13.9 billion per year. The indirect, intangible costs people with diabetic foot disease are also high, with many experiencing a poorer quality of life than those without foot disease.¹⁷ 85% of amputations are preceded by a DFU,¹⁸ people who develop a DFU are also at greater risk of premature death, myocardial infarction and fatal stroke than those without a history of DFUs.¹⁹  

DFUs have a significant impact on patients, and the expert panel concluded that topical oxygen therapy should be considered as an adjunct to best practice for DFUs due to its ability to improve outcomes in patients. 

-ENDS-

References:

1. Guest JF, Ayoub N, McIlwraith T et al (2015) Health economic burden that wounds impose on the National Health Service in the UK. BMJ Open
2. Expert Panel Report. The role of topical oxygen therapy in the management of diabetic foot ulcers. London: The Diabetic Foot Journal, 2019. Available to download from: www.diabetesonthenet.com
3. Bus SA, van Deursen RW, Armstrong DG, et al (2016) Footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in patients with diabetes: a systematic review. Diabetes Metab Res Rev 32(suppl 1): 99–118
4. Alexiadou K, Doupis J. Management of diabetic foot ulcers. Diabetes Ther. 2012 Dec; 3(1):4.
5. Dissemond J, Kroger K, Storck M et al (2015). Topical oxygen wound therapies for chronic wounds: a review. J Wound Care 24(2):53–63
6. Gottrup F, Dissemond J, Baines et al (2017). Use of oxygen therapies in wound healing, with special focus on topical and hyperbaric oxygen treatment. J Wound Care 26(5): Suppl S1–S42
7. Arenbergerova M, Engels P, Gkalpakiotis S et al (2013). Effect of topical haemoglobin on venous leg ulcer healing. EWMA J 13(2): 25–30
8. Bateman S (2015). Topical haemoglobin spray for diabetic foot ulceration. Br J Nurs 24(12): S24–29
9. Haycocks S, McCardle J, Findlow AH et al (2016).Topical oxygenation therapy for non-healing diabetic foot ulcers. Br J Nurs 25(6): S2–10
10. Hunt S, Elg F (2017). The clinical effectiveness of haemoglobin spray as adjunctive therapy in the treatment of chronic wounds. J Wound Care 26(9):558–568
11. Elg F, Hunt S (2018) Hemoglobin spray as adjunct therapy in complex wounds: Meta-analysis versus standard care alone in pooled data by wound type across three retrospective cohort controlled evaluations. SAGE Open Medicine: Jun 6:2050312118784313
12. Hunt S. Elg F (2016) Clinical effectiveness of hemoglobin spray (Granulox®) as adjunctive therapy in the treatment of chronic diabetic foot ulcers. Diabetic Foot & Ankle 7:33101
13. Hunt S, Elg F, Percival S (2018) Assessment of clinical effectiveness of haemoglobin spray as adjunctive therapy in the treatment of sloughy wounds. Journal Wound Care 27(4): 210-219
14. Boulton AJ, Vileikyte L, Ragnarson-Tennvall G, Apelqvist J (2005). The global burden of diabetic foot disease. Lancet 366(9498): 1719–24
15. Kerr M (2017). Diabetic Foot Care in England: an economic study. London: Insight Health Economics for Diabetes UK
16. Guest JF, Fuller GW, Vowden P (2018). Diabetic foot ulcer management in clinical practice in the UK: costs and outcomes. Int Wound J 15: 43–52
17. Vileikyte L (2001). Diabetic foot ulcers: a quality of life issue. Diabetes Metab Res Rev 17: 246–9
18. Edmonds M (2013) Modern treatment of infection and ischaemia to reduce major amputation in the diabetic foot. Curr Pharm Des 19: 5008–15
19. Brownrigg JR, Davey J, Holt PJ et al (2012). The association of ulceration of the foot with cardiovascular and all-cause mortality in patients with diabetes: a meta-analysis. Diabetologia 55(11): 2906–12

 

For further information or to arrange photography/further interviews please contact:

 

Angela Gonzalez, Mölnlycke Press Office

Angela.Gonzalez@fourhealthcommunications.com

Tel: +44 20 3907 8984

 

Notes to editors

 

About the Expert Panel Report:

The role of topical oxygen therapy in the management of diabetic foot ulcers was developed by The Diabetic Foot Journal and supported by Mölnlycke. The panel comprised: Paul Chadwick (Chair), Visiting Professor, Birmingham City University; Mike Edmonds, Professor of Diabetic Foot Medicine, King’s College London, and Consultant Physician, King’s College Hospital; Adam Fox, Highly Specialist Podiatrist, Cardiff and Vale UHB – Podiatry; Richard Leigh, Consultant Podiatrist, Royal Free London NHS Foundation Trust, and Visiting Professor, PSMU; Duncan Stang, Diabetes Foot Co-ordinator, Scotland; Stella Vig, Consultant Vascular and General Surgeon, Croydon University Hospital. The report was reviewed by Luxmi Dhoonmoon, Nurse Consultant Tissue Viability, Central and North West London NHS Foundation Trust (CNWL).

 

About Mölnlycke:

Mölnlycke is a world-leading medical solutions company. We are here to advance performance in healthcare across the world, and we aspire to equip everybody in healthcare with solutions to achieve the best outcomes. We collaborate with customers to understand their needs. We design and supply medical solutions to enhance performance at every point of care – from the operating room to the home. For more information on Mölnlycke visit www.molnlycke.co.uk.

 

About Granulox^®

Granulox^® is a haemoglobin oxygenating spray for the treatment of chronic wounds, including diabetic foot ulcers, venous leg ulcers, arterial leg ulcers, and mixed leg ulcers for the secondary healing of surgical wounds and pressure sores. It can also be used on healing of sloughy and infected wounds. When Granulox^® is sprayed on a wound, highly purified haemoglobin is released. This binds with oxygen from the environment and diffuses through the wound exudate, and the haemoglobin supplies the base of the wound topically with oxygen. The oxygen supply to the base of the wound supports wound healing and patient outcomes. A convenient spray application makes Granulox^® a portable and easy-to-use adjunct to standard of care wound treatment. Granulox^® can be applied when the wound dressing is changed, and at least every three days for optimal results. Granulox is produced and distributed by Mölnlycke, for more information visit: www.molnlycke.co.uk/products-solutions/granulox/.