Diabetic Foot Ulcers

Increasing Prevalence of Diabetes in Australia

According to the 2005 Australian AusDiab Follow-up Study, around 1 million Australians are diagnosed with diabetes with another 16.3% classed as pre-diabetic. It is likely to be an even greater problem than these figures indicate, as it is estimated that for each person diagnosed with diabetes, another diabetic is undiagnosed. This makes a total of around 1.7 million Australian diabetics (diagnosed and undiagnosed)¹⁵. The total figure of Australians with diabetes and pre-diabetes is estimated at 3.2 million¹⁶.

Diabetes is associated with reduced circulation (peripheral vascular disease) and nerve damage (peripheral neuropathy) in the lower extremities. These two factors increase the risk of diabetic or neuropathic wounds in diabetic patients.

Diabetic or neuropathic wounds in diabetic patients often result in ulceration and full or partial amputation of the toes, feet and/or lower limbs ^{15, 17, 19}. Such diabetic ulcers can usually be found in the lower limb region and are called diabetic foot ulcers. The AusDiab Baseline study (2001) found that 2.1% of diabetics have suffered from foot ulceration before and 19.6 % of people with diabetes are at risk of developing non-healing foot ulcers ¹⁸.

The current prevalence rate of foot ulcers lies at 1.7% of adults attending a diabetes clinic²⁰. Diabetes is estimated to account for approximately half of all non-traumatic amputations ¹⁷.

Example 1

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Example 2

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Example 1: ulcer fully healed at week 6, photos taken at visit 11 (week 12).
Example 2: ulcer fully healed at week 8, photos taken at visit 11 (week 12).

Treatment of Diabetic Foot Ulcers

The non-invasive and quick treatments can easily be integrated into current protocols (i.e. after debridement and wound measurement) and will take approximately 2-6 minutes of painless active treatment.

Biologic Effects of dermaPACE treatments

PACE treatments penetrate the microcirculatory system. PACE treatment results in an increase in perfusion and arteriogenesis, biofilm disruption, a pro-inflammatory response, cytokine and chemokine effects, growth factor upregulation, angiogenesis (new blood vessel formation) and the subsequent regeneration of tissue such as skin, musculoskeletal and vascular structures.

Biological effects of dermaPACE treatments

Click to read more about each process:

Perfusion & Arteriogenesis

PACE treatment leads to an increase in perfusion. As the PACE shock waves penetrate the microcirculatory system, there is an immediate change in local blood flow in the treated area.^1,2,3

Biofilm

Shock wave treatment can break up the physical biofilm barriers. ⁴

Inflammatory Modulation

After PACE treatment the wound moves quickly through the inflammatory phase (increase in leukocyte activity) to the cell duplication phase (proliferation) of healing. ^2,5,6,7

Cytokines and Chemokines

Inflammatory and pro-angiogenic phases are accompanied by increases of cytokines and chemokines 6 hours after and up to 7 days post-treatment. ^2,5,6,7,8

Growth factor Upregulation

PACE treatments apply mechanical forces to the individual cells in the treatment area and thus, creating a biological response called “cellular expression”. This describes the incidence when the cells produce wound healing proteins called pro-angiogenic growth factors. Growth factor upregulation can persist for up to 12 weeks. ^2,5,6,7,8,9

Angiogenesis

A network of new vessels is formed in the treated area. VEGF (vascular endothelial growth factors) indicate the growth of new capillaries to allow an improved blood flow in the wound. Researchers reported an increase in VEGF after dermaPACE treatments. 8 Other studies compared ESWT with topical VEGF application in ischemic tissues and shock wave treatment outperformed VEGF application. ^{2,7,8,10,11,12}

Granulation

Granulation or cellular proliferation describes the stage when cells multiply to cover and close the wound. Research has shown that after PACE treatment, there is a significant increase of proliferative cells which indicates that PACE treatments may accelerate wound granulation.8 Stojadinovic et al (2008) reported marked granulation tissue development on post-treatment day 4. Saggini et al (2008) reported considerably increased granulation tissue in the wounds of treated patients after shock wave treatment. ^7,8,13

Epithelialization

A recent phase III clinical trial strongly suggests that dermaPACE has an effect in the stabilization, size reduction and with time, complete re-epithelialization of wounds specifically diabetic foot ulcers (DFU). Epithelialization of greater than 90% was demonstrated to have statistical importance at 12 weeks in favour of PACE treated wounds compared with the placebo group. (p=0.016). Overall PACE treated wounds were twice as likely to achieve 90-100% wound closure compared with sham-control patients within 12 weeks. ¹⁴

References

15. Australian AusDiab Follow up Study, 2005.
16. Diabetes in Australia. Viewed on 13.05.2013.
17. Diabetes: Australian Facts 2008. Viewed on 16.05.2013.
18. Australian AusDiab Baseline Study, 2001.
19. IDF 2013. Complications of Diabetes. Viewed 13.05.2013.
20. ANDIAB Data 2009.