Healing enhancement of chronic venous stasis ulcers utilizing H-WAVE.sup.[R] .sup.device therapy: a case series

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From: Cases Journal(Vol. 3)
Publisher: Cases Network Ltd.
Document Type: Case study
Length: 3,488 words

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Authors: Kenneth Blum (corresponding author) [1,4,5,6,8]; Amanda LH Chen [2]; Thomas JH Chen [3]; B William Downs [4]; Eric R Braverman [4,5]; Mallory Kerner [5]; Stella Savarimuthu [5]; Anish Bajaj [5]; Margaret Madigan [6]; Seth H Blum [6]; Gary Reinl [7]; John Giordano [8]; Nicholas DiNubile [9]


The worldwide increase in prevalence of type 2 diabetes has resulted in a parallel increase in diabetic foot ulcers, which is a pervasive and significant problem associated with this disease [1]. Currently, an estimated 10.3 million people have been diagnosed with diabetes, while an additional estimated 5.4 million people with diabetes remain undiagnosed, representing a six-fold increase in the incidence of diabetes over the past four decades [2]. Approximately 15% (more than 2 million individuals, based on these estimates) of all people with diabetes will develop a lower-extremity ulcer during the course of the disease [3]. While most of these ulcers can be treated successfully on an outpatient basis, some will persist and become infected. Ultimately, between 14% and 20% of patients with lower-extremity diabetic ulcers will require amputation of the affected limb [4]. Diabetic foot ulcers can result in staggering financial burdens for both the healthcare system and the patient. For example, analysis of the 1995 Medicare claims revealed that lower-extremity ulcer care accounted for $1.45 billion in Medicare costs and contributed substantially to the high cost of care for diabetics, compared with Medicare costs for the general population [5]. A search in PUBMED revealed that there has not been an update published on the actual cost of Medicare for diabetic ulcers, however the cost as stated earlier they have been increasing at the rate of six-fold over the last four decades [6]. While there are other conditions that result in chronic venous stasis ulcers such as vein striping failed surgery, diabetes is a major etiology of this condition. Therapies that promote rapid and complete healing and reduce the need for expensive surgical procedures would impact these costs substantially.

It is important to note that while the etiology of diabetic foot ulcers is the impairment of microcirculation and autonomic dysfunction, the causes of chronic venous insufficiency are multiple. One of the possible causes of chronic venous insufficiency is extraluminal lipoma with common femoral vein obstruction. However it is also of note that the etiology may be best explained by the well-known valve cusp hypothesis. In this scenario firstly, should the foregoing events not proceed to frank thrombogenesis, the valves may nevertheless be chronically injured and become incompetent. Serial incompetence in lower limb valves may then generate "passive" venous hypertension. Secondly, should ostial valve thrombosis obstruct venous return from muscles via tributaries draining into the femoral vein, "active" venous hypertension may supervene. Muscle contraction would force the blood in the vessels behind the blocked ostial valves to re-route. Passive or active venous hypertension opposes return flow, leading to luminal hypoxemia and vein wall distension, which in turn may impair vasa venarum perfusion; the resulting mural endothelial hypoxia would lead to leukocyte invasion...

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Gale Document Number: GALE|A220171172