Rheopheresis in Patients with Ischemic Diabetic Foot Syndrome: Results of an Open Label Prospective Pilot Trial

Abstract

Rheopheresis is a specific application of membrane differential filtration, synonymous with double filtration plasmapheresis, for extracorporeal hemorheotherapy. Safety and efficacy of Rheopheresis for wound healing and skin oxygenation were investigated in patients with ischemic diabetic foot syndrome. Eight patients with type 2 diabetes mellitus and non-healing foot ulcers caused by severe ischemic diabetic foot syndrome were treated by a series of seven Rheopheresis sessions in a time span of 11 weeks. Wound healing had not been detectable under conditions of standardized wound care during at least 2 months. Wound status was classified by its morphology, severity and location, according to the criteria of Wagner. Transcutaneous oxygen pressure (tcPO2), laser Doppler flowmetry and vital capillary microscopy were repeatedly performed to monitor the effects of the Rheopheresis treatment series on microcirculation and skin blood flow. Laboratory parameters of blood rheology, endothelial function and inflammatory state were measured in addition to safety parameters. In four patients (baseline Wagner stage 2), Rheopheresis accelerated wound healing of foot ulcers and was associated with an improvement of Wagner stage and a pronounced increase in tcPO2. In two patients (baseline Wagner stage 2), wound healing was unchanged but mean tcPO2 increased, allowing successful minor amputation. Values of tcPO2 remained stable and enhanced for the 3 months follow-up period. In two patients (baseline Wagner stage 4 or 5), no improvements in foot lesions were observed within the treatment period. As an adjunct therapeutic option, Rheopheresis may preserve a functional lower extremity, delay amputation or reduce the extent of amputation.

Prospective, randomized, controlled clinical study evaluating the efficacy of Rheopheresis for dry age-related macular degeneration

“…In the treatment group, the mean reduction rates achieved were: for LDL 64.9% (s=0.09), for alpha-2-macroglobulin 52.5% (s=0.15) and for fibrinogen 59.6% (s=0.12), demonstrating an efficient reduction of hemorheological parameters which is in accord to already published data [10,11].…”

“…A systematic decrease in choroidal circulatory parameters was observed in combination with an increase in the severity of AMD features associated with risk for the development of choroidal neovascularisations (CNV), supporting the role of ischemia in the development of CNV [26]. Rheopheresis has been demonstrated to increase oxygen concentration in ischemic tissues [10,11]. Improvement of the pulsatile ocular blood flow and shortening of the arteriovenous passage time in patients with AMD after Rheopheresis treatment demonstrated a positive effect of Rheopheresis on the microcirculation directly in the eye [27,28].…”

“…Results from prospective clinical trials with patients suffering from AMD and microcirculatory disorders of other tissue beds (e.g. ischemic diabetic foot, critical limb ischemia, diabetic retinopathy, and sudden sensorineural hearing loss) can be mentioned as proof of principle [10][11][12][13]. The primary objective of Rheopheresis is to preserve and potentially restore functional vision in AMD patients.…”

Quality of Life in Patients With Idiopathic Sudden Hearing Loss

“…Rheopheresis is a method of therapeutic apheresis using double-filtration plasmapheresis with a specifically designed plasma filter (Rheofilter) to eliminate high molecular weight plasma components (950 kd) such as LDL-cholesterol, fibrinogen, lipoprotein (a), >-2-macroglobulin, and von Willebrand factor from plasma (10,11). Rheopheresis treatment consisted of 1 to 2 sessions of Rheopheresis within 5 T 2 days.…”

Gesicherte Indikationen zur Plasmapherese-Therapie bei internistischen und neurologischen Notfällen

“…Die Datenlage zur Anwendung der rheologisch wirksamen Apherese für die Behandlung Diabetes-assozi-ierter Komplikationen (diabetische Retinopathie und Fuß), der akuten ischämischen Optikusneuropathie beziehungsweise von Hyperviskositätssyndromen sind auf Einzelfälle, kleinen Serien oder Studien mit geringer Fallzahl beschränkt (18,19), sodass bei diesen Erkrankungen derzeit noch keine generelle Behandlungsempfehlung hinsichtlich des Einsatzes eines Aphereseverfahrens abzugeben ist.…”