Regular Use of FlowAid FA100 SCCD Reduces Pain While Increasing Perfusion and Tissue Oxygenation in Contralateral Limbs of Amputees With Diabetic Neuropathy and Peripheral Arterial Disease: Results of an Open, Pre-Post Intervention, Single-Center Study.

Patients with diabetic neuropathy and peripheral arterial disease often suffer pain, develop foot wounds, and go on to lose limbs leaving them with a painful limb. Electrical stimulation is one possibility open to physicians. In this study, the effects of the FlowAid FA100 SCCD, a sequential contraction compression device, were tested. The FA100 device is noninvasive; it uses 4 electrodes to sequentially stimulate the calf muscles in a modified intermittent pneumatic compression manner. A total of 14 patients with diabetic neuropathy, peripheral arterial disease, unilateral amputation, and a painful limb were treated with FlowAid FA100 (FlowAid Medical Technologies Corporation, New York, NY) with prior ethical approval. The study design was open, pre-post intervention comparison, and nonrandomized. Pain perceived was measured using Visual Analogue Scale (VAS) scores. Assessments of ankle brachial index (ABI), ultrasound color Duplex, and tissue oxygen using the transcutaneous oxygen technique were done at baseline and 2 successive follow-ups 4 weeks apart. Three out of 14 patients dropped out on account of distances involved in traveling to the clinic. Eleven out of 14 patients experienced statistically significant reduction in pain mean VAS scores (7.5 ± 0.93 to 5.8 ± 1.47, P = .002) associated with increase in ABI (0.64 ± 0.06 to 0.69 ± 0.04, P < .001) and transcutaneous oxygen tension measured on the dorsum (29.4 ± 4.03 to 33.2 ± 5.26 in mm Hg, P = .005). When pain scores were regressed against ABI and transcutaneous oxygen tension values, there was a significant association between these (r = 0.8, P = .002). The reduction in pain following regular use of FlowAid was accompanied by beneficial and statistically significant increases in perfusion and oxygenation.

Effect of a polyherbal formulation cream on diabetic neuropathic pain among patients with type 2 diabetes - A pilot study.

BACKGROUND & OBJECTIVES: Painful diabetic neuropathy is a common complication of diabetes and can severely limit patients' daily functions. The aim of this pilot study was to evaluate the safety and effect of using a polyherbal formulation in reducing the symptoms of diabetic neuropathic pain in comparison with placebo among patients with type 2 diabetes. METHODS: A total of 50 (M:F = 33:17) consecutive type 2 diabetes patients with painful diabetic neuropathy were enrolled in this study. All these patients had either two or more symptoms of diabetic neuropathy such as pain, burning and pricking sensations and numbness in their feet. They were randomly assigned to two groups: group 1 (n = 26) patients were treated with polyherbal formulation cream and group 2 (n = 24) patients were administered placebo. The patients were followed up for six months. Changes in the symptoms of painful diabetic neuropathy of each patient were recorded at baseline, third and sixth month using the Diabetic Neuropathic Score. RESULTS: The mean age of the patients, duration of diabetes and glycated haemoglobin (HbA 1c ) were similar in both groups at baseline. During follow up visits, there was a decrease in the HbA 1c levels in the study and control groups. The symptoms of painful diabetic neuropathy were also similar in both groups at baseline. A significant decrease in symptoms of neuropathic pain was observed among the group of patients treated with polyherbal formulation cream (76.9 per cent) compared to the placebo-treated group (12.5 per cent) (P<0.001), at the end of the final follow up. INTERPRETATION & CONCLUSIONS: In this pilot study polyherbal formulation cream was found to be effective as well as safe to treat painful diabetic neuropathy. However, its long term use needs to be evaluated for any further effectiveness and side effects.