Background

Increasing experimental and clinical evidence suggests that illumination of the skin with relatively low intensity light may lead to therapeutic results such as reduced pain or improved wound healing. The goal of this study was to evaluate prospectively whether socks made from polyethylene terephthalate (PET) incorporating optically active particles (Celliant™) ameliorates chronic foot pain resulting from diabetic neuropathy or other disorders. Such optically modified fiber is thought to modify the illumination of the skin in the visible and infrared portions of the spectrum, and consequently reduce pain.

Methods

A double-blind, randomized trial with 55 subjects (38 men, 17 women) enrolled (average age 59.7 ± 11.9 years), 26 with diabetic neuropathy and 29 with other pain etiologies. Subjects twice completed the Visual Analogue Scale (VAS), Brief Pain Inventory (BPI), McGill Pain Questionnaire (MPQ), and SF-36 a week apart (W₁₊₂) before receiving either control or Celliant™ socks. The same questionnaires were answered again one and two weeks (W₃₊₄) later. The questionnaires provided nine scores for analyzing pain reduction: one VAS score, two BPI scores, five MPQ scores, and the bodily pain score on the SF-36. Mean W₁₊₂ and W₃₊₄ scores were compared to measure pain reduction.

Results

More pain reduction was reported by Celliant™ subjects for 8 of the 9 pain questions employed, with a significant (p = 0.043) difference between controls and Celliant™ for McGill question III. In neuropathic subjects, Celliant™ caused more pain reduction in 6 of the 9 questions, but not significantly. In non-neuropathic subjects 8 of 9 questions showed more pain reduction with the Celliant™ socks.

Conclusion

Socks with optically modified PET (Celliant™) appear to have a beneficial impact on chronic foot pain. The mechanism could be related to the effects seen with illumination of tissues with visible and infrared light.

Trial Registration

ClinicalTrials.gov NCT00458497

Current embodiments of negative pressure wound therapy (NPWT) create a hermetically sealed chamber at the surface of the body using polyurethane foam connected to a vacuum pump, which is then covered by a flexible adhesive drape. Commercially available NPWT systems routinely use flexible polyethylene films that have a sticky side, coated with the same acrylate adhesives used in other medical devices such as ECG leads and grounding pads. Severe reactions to the acrylate adhesives in these other devices, although uncommon, have been reported. We describe the case of a 63-year-old woman with an intractable leg ulcer resulting from external-beam radiotherapy (XRT). Treatment with a standard commercial NPWT system induced severe inflammation of the skin in direct contact with drape adhesive. We successfully administered prolonged, outpatient NPWT to the patient using an alternative method (first described by Bagautdinov in 1986), using plain polyethylene film and petrolatum. The necessary hermetic seal is achieved by smearing the skin with petrolatum before applying the polyethylene film and activating the vacuum pump. The Bagautdinov method is a practical solution to the problem of adapting NPWT to patients with contact sensitivity or skin tears related to the adhesive compounds in the flexible drapes. Its use of a circumferential elastic wrap to maintain constant pressure on the seal probably limits the Bagautdinov technique to the extremities.

Background

Patients undergoing percutaneous recanalization of chronically occluded superficial femoral arteries were studied to determine which factors correlated with 1-year patency. Immediate change in ankle:brachial index (ABI), length of occlusion, tibial run-off, and the performance of supplemental catheter atherectomy were evaluated.

Methods

Eligible patients had at least one patient tibial run-off vessel and the absence of limb-threatening ischemia. Recanalization was performed via passage of a guidewire followed by balloon angioplasty. Tibial run-off was scored based on a modification of the angiogram scoring system of the Society for Vascular Surgery and the International Society for Cardiovascular Surgery. Supplemental transcutaneous extraction catheter atherectomy was randomly assigned to a sub-group of patients after initial experience with the recanalization technique. Clinical follow-up was employed to determine patency.

Results

Forty-two of 57 attempts (74%) at recanalization were immediately successful. Overall 1-year patency was 40% in 40 limbs that could be followed. In limbs with balloon angioplasty alone (n = 23), patency was 43% compared with 35% in those having supplemental atherectomy. Tibial run-off did not vary significantly between patent and occluded groups. When ABI increased by 0.3 or more, patency was 56% compared with 26% when the ABI increase was less than or equal to 0.1 (P = 0.13). Occlusion length averaged 18.1 +/- 10.6 cm for all limbs and did not vary significantly between early successes and failures. Limbs with short occlusions (less than or equal to 5 cm, n = 8) had 63% patency compared with 38% patency for limbs with long occlusions (greater than 25 cm, n = 16), but the difference was not significant by analysis of variance.

Conclusions

An initial change in ABI was most predictive for patency, whereas no correlation with tibial run-off was demonstrated. Atherectomy did not increase patency. Short occlusions were more likely to remain patent than long ones, but overall patency was lower than described in other series.

Myointimal hyperplasia (MIH) after vascular intervention is a major problem. Recent reports describing elimination of within-stent restenosis by means of rapamycin-eluting stents prompted us to examine the effect of systemic oral rapamycin on MIH induced by arterial trauma. We studied the effect of oral rapamycin on MIH after rabbit aorta balloon injury. Thirty-five New Zealand white rabbits (2.5-3 kg) had aortic injury and were given either no rapamycin (control), 0.1 (low dose) rapamycin mg/kg/day, or 0.4 mg/kg/day (high dose). Rapamycin was started 1 week before injury and continued for 3 (4 weeks total) or 6 weeks (7 weeks total) post-injury. Sections were analyzed to measure aortic intima/media area ratios (I:M) at either 3 or 6 weeks. At 3 weeks, the I:M (mean +/- SD) for controls was 0.53 +/- 0.1; for low dose, 0.17 +/- 0.13; and for high dose, 0.24 +/- 0.07 (p < 0.001 vs. control). At 6 weeks, the I:M for controls was 0.52 +/- 0.12; for low dose-4 weeks, 0.29 +/- 0.15; low dose-7 weeks, 0.33 +/- 0.07; and high dose-4 weeks, 0.47 +/- 0.16. At 6 weeks only the difference between the low dose-4 weeks and control I:M ratios was significant (p = 0.018). The results confirm earlier studies showing that systemic rapamycin inhibits MIH after arterial injury when drug therapy is started before injury. Therapy for 3 or 6 weeks after injury yields similar inhibition, indicating that exposure to the drug early in the response to injury is more important than prolonged exposure. We observed a paradoxical relation between dose and degree of MIH inhibition, with the low dose being more effective than the high dose at both time intervals studied. Overall, the results suggest that oral rapamycin therapy might be a useful adjunct to clinical interventions at risk for development of MIH.

The success rate of percutaneous transluminal coronary angioplasty for chronic total arterial occlusions is still unsatisfactory. Inability to cross the lesion with a guidewire is a major cause of failure. Optical coherent reflectometry (OCR) is a new method of using laser light to measure the depth of tissue from the end of an optic fiber. This study tests whether an OCR prototype guidewire provides a guidance system that might be useful to assist reopening chronic total arterial occlusions. An OCR fiber optic within a 0.014" hypotube was developed using the interference pattern of two reflected light beams (wave length 1,300 nm). To determine if OCR can distinguish different tissue types, plaques of human lower extremity arterial segments were visually divided into three types (calcified, white, or yellow). The slope of the initial reflectance of the OCR curve was calculated and compared between the three groups. In six other arteries, the OCR wire was advanced longitudinally through occluded human artery segments in vitro. Guidewire position was determined by OCR and compared to the position of the guidewire tip observed simultaneously by intravascular ultrasound (IVUS) imaging. In 16 arterial surface segments, calcified plaques had a significantly steeper slope than white or yellow plaques (-227.2 +/- 82.2; -81.5 +/- 12.9; -103.6 +/- 19.6 dB/mm; P < 0.01). For the determination of the guidewire position, IVUS and OCR corresponded correctly in 82% of 28 measurements. Sensitivity and specificity of OCR for detection of plaque versus the media/adventitia boundary were 79% and 89%, respectively (P < 0.001). OCR can distinguish calcified from noncalcified plaque and may distinguish plaque from the media/adventitia boundary. This technology may be useful as a means to help navigate a guidewire safely through an occluded artery.

Objectives

The purpose of this study was to test the hypothesis that in occlusions of the superficial femoral artery, removal of atherosclerotic plaque would result in a higher long-term patency rate compared to balloon dilatation alone. A secondary hypothesis was that long term patency would be proportional to the amount of plaque removed.

Methods

A randomized controlled study of patients with occluded superficial femoral arteries was performed comparing balloon dilatation alone versus a 2.7 mm or a larger (4.0 mm or 4.7 mm) transcutaneous extraction catheter (TEC) atherectomy device followed by balloon dilatation. The effect of these devices on plaque area was assessed directly by intravascular ultrasound imaging.

Results

The mean occlusion length was 19.4 cm +/- 11.7 cm. The mean lumen area increased from 4.7 mm2 to 15.1 mm2, primarily due to balloon dilatation, but the mean atheroma area of 19.8 mm2 did not change with either size of TEC device. Although the initial procedure success rate was high (79%), the 6 month patency was only 45%. There was no difference in 6 month patency between the 3 groups.

Conclusions

The data indicate that the TEC atherectomy devices do not remove a significant amount of atherosclerotic plaque in occluded superficial femoral arteries. The 6 month patency is no different with these atherectomy devices than with balloon dilatation alone. The larger (4.0 mm or 4.7 mm) TEC device does not remove any more tissue than the smaller (2.7 mm) device. The use of intravascular ultrasound to quantitate the effects of this atherectomy device provides important insights into the mechanism of action and lack of efficacy of the TEC atherectomy catheter.