THE PROBLEM

We have researched the problem of non-healing wounds and summarize here the mechanism of diabetes and rheumatoid arthritis and its consequences on health and society.

CAUSES OF NON-HEALING WOUNDS

DIABETIC FOOT ULCERS

One big cause of non-healing wounds is diabetes. The global prevalence of diabetes was measured to 422 million in 2014. Approximately 63 million of all diabetics will develop a diabetic foot ulcer (DFU) during their lifetime and around 3.8 million of them will need acute hospital care because of complications of non healing wounds. On average, the wounds heal closed in 12-13 months, but reoccur later in half of all patients with a previous DFU. 

One cause of DFU is narrowing of the blood vessels farthest away from the heart. This leads to a circulation in the feet, which leads to a decreased supply of oxygen and nutrients to the tissue, as well as reduced elimination of waste products from the affected tissue.

The increased blood sugar from diabetes leads to a reduced effectiveness of the immune system, obstructing immune reactions necessary to fight infections in the wound. At the same time, the inflammation phase of wound healing is prolonged, contributing to a slower healing process. This is partially because the feet in particular are exposed to a high mechanical load when walking, breaking down new tissue and triggering further inflammation by constant trauma.

Furthermore, excessive blood sugar feeds bacteria, contributing to infection. The patient might also have diabetic nephropathy as a long term complication of diabetes, which contributes to an accumulation of waste products in the wound, slowing down wound healing further. 

RHEUMATOID ARTHRITIS

Although our product is primarily aimed for use by diabetics with non-healing foot wounds, there might be a potential for other patient groups with chronic wounds that might benefit from the treatment.

Rheumatoid arthritis (RA) is a less common disease than diabetes, with a prevalence of 1% of the world’s population, 3.9% in the UK and 4.37% in the US. 

This patient group also has chronic foot ulcers caused by a reduced blood circulation in the feet due to inflammation  of the blood vessels (cutaneous rheumatoid vasculitis) and narrowing of blood vessels in the feet (peripheral arterial disease), deformation of the feet and other factors. 

Corticosteroids are often used to treat RA. They may not be appropriate for patients at high risk of ulceration as they have an adverse impact on the inflammatory and proliferative stages of wound healing as well as wound contracture. In addition to this, individuals on long-term steroid therapy develop paper-thin skin that is susceptible to tears and breaks easily when traumatised. 

LIV treatment could serve as an alternative or complement to corticosteroids to promote an increase of skin blood flow and pro-healing growth factors.

ECONOMIC OUTCOMES

In Sweden, the expenses incurred as a total cost for healing diabetic foot ulcers was estimated around US$ 24,965 per patient without amputation while they were around US$ 47,518 and US$ 42,858 with amputation with minor and major surgeries respectively.

In the US alone the total medical cost for the management of DFU ranges from US$9 to US$13 billion in addition to the cost for management of diabetes alone.

Other than the healthcare costs mentioned above, the affected person gets additional expenses directly related to the foot wound and gets fewer employment opportunities, causing another sense of deep loss. 

CLINICAL OUTCOMES

Diabetic foot wounds are one of the most common reasons for hospitalization of diabetics. As the wound gets worse, tissue death (gangrene), severe infections or blood poisoning (sepsis) occur as a consequence of lacking blood flow or a bacterial infection. Every year, 5% of all diabetics develop a foot ulcer and 1% get a foot amputation as the only remaining option to save the limb or life of the person. Diabetics are overrepresented at around 66% of nontraumatic amputations in the US and the mortality rate is 36% within 2 years from a below-knee amputation. 

The biggest consequence of chronic foot wounds is an overall decreased health related quality of life. People with DFU suffer from involuntary lifestyle changes as a cause of their immobility and increased medical needs. Socially, the person’s family life and social life is affected negatively because of immobility and added pressure and burden on family members. On a psychological level, DFU increases frustration, guilt and depression. Physically, the person is affected negatively by impaired mobility and pain. 

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