Diabetes
* Diabetic neuropathy. Results of a long-term study published in the January 2006 issue of the Journal of Palliative Medicine indicate that duloxetine HCl (Cymbalta; Eli Lilly and Co, Indianapolis, IN) is as safe as routine care that uses one or more medications to manage pain caused by diabetic neuropathy. The 52-week study of more than 200 patients compared duloxetine HCl, a nonnarcotic prescription medication for the management of diabetic neuropathy, with routine care, which included beneficial patient therapies such as anticonvulsants and antidepressants.The researchers also found that the drug did not adversely affect the progression of diabetes or many of the disease's complications, such as nerve, kidney, and eye damage. The management of diabetes in both study groups was adjusted at the discretion of the investigator. According to the data, there were no significant differences in the overall incidence of adverse events resulting from treatment or in quality of life measures in the group taking duloxetine HCl versus those receiving routine care.Source: Raskin J, Smith TR, Wong K, et al. Duloxetine versus routine care in the long-term management of diabetic peripheral neuropathic pain. J Palliat Med. 2006;9:29-40.
* Peripheral sensory loss. According to a survey published in the Canadian Medical Association Journal, taller persons with diabetes have a greater risk of developing peripheral sensory loss than shorter persons with the disease. This may also increase their risk of lower-extremity ulcers and amputation.
In a telephone survey of 93,116 persons with diabetes conducted between 1995 and 2002 in Taiwan, approximately 3.5% had type 1 diabetes. Within that population, 1.7% had had an amputation. The majority of persons surveyed had type 2 diabetes; 0.8% of them had experienced a lower-extremity amputation.
The researchers did not find any significant differences in the prevalence of amputation between men and women; however, height was a factor. According to the study, every additional 10 cm of height was associated with a 16% increase in the risk of amputation.
Source: Tseng CH. Prevalence of lower-extremity amputation among patients with diabetes mellitus: is height a factor? CMAJ. 2006;174:319-23.
Venous Ulcers
The 60-patient confirmatory trial to evaluate OrCel (Ortec International, Inc, New York, NY) for the treatment of venous leg ulcers is under way at 9 active clinical centers. Approximately 40 patients are enrolled, with more than half having completed the treatment phase of the trial. The remaining 20 patients required to complete patient enrollment were expected to be enrolled by the end of February 2006.
The confirmatory study is being conducted at the request of the Food and Drug Administration to confirm clinical results generated in Ortec's trial that was previously submitted as part of a premarket approval application filed by Ortec. Clinical data from the 12-week pivotal trial showed that 59% of the OrCel-treated patients achieved wound closure versus 36% of the patients who received standard treatment.
[black up pointing small triangle] Information:http://www.ortecinternational.com
Wound Healing
A new study in the December issue of Archives of General Psychiatry reports that marital stress slowed the healing time of blister wounds. Stress has been linked with a change in the production of proinflammatory cytokines, proteins in cells that play a key role in wound healing. Changes in blood pressure and endocrine levels may also contribute to the slowed healing process. Marital discord has been associated as a risk factor for several illnesses, according to the article.
The researchers found that couples' blister wounds healed more slowly and had lower local cytokine production at the wound site following marital conflicts than after social support interactions. Couples who demonstrated consistently higher levels of hostile behaviors across both their interactions healed at 60% of the rate of low-hostile couples, and they had a median time to healing of 1 day longer.
[black up pointing small triangle] Information:http://www.archpsyc.ama-assn.org
Nonhealing Chronic Ulcers
At the Stuttgart 2005 Diabetic Ulcer Care Symposium, researchers from the University of Dusseldorf presented the initial results of the first 41 patients treated using the Harvest SmartPReP APC+ Platelet Concentration System (Harvest Technologies Corp, Plymouth, MA) to treat serious, nonhealing chronic wounds. The treated nonhealing chronic ulcers were classified as either Wagner grade 2 or 3, and healing was described as total closure. It was reported that 27 out of 41 patients (65%) achieved full closure, with an average closure time of 11 weeks. In addition, significant benefit from the therapy was seen in 39 of the 41 patients (93%) with regard to wound size reduction or marked improvement of granulation tissue.
The Harvest SmartPReP System automates the platelet concentration process, removing operator variability, and incorporates a patented floating shelf technology that precisely captures the platelets; this consistently yields 4 to 6 times concentration. The system also produces an autologous thrombin used to activate platelets.
[black up pointing small triangle] Information:http://www.harvesttech.com
Tissue Repair Cells
The first clinical trial using proprietary tissue repair cells (TRCs) from Aastrom Biosciences, Inc, Ann Arbor, MI, has been initiated at the Diabetes Center at the Heart and Diabetes Center North Rhine-Westphalia, located in Bad Oeynhausen, Germany. A collaborative effort between Aastrom and the Diabetes Center, the study is intended to evaluate the safety and ability of Aastrom's bone marrow-derived TRCs to regenerate functioning blood vessels in the legs of patients who are diabetic and have limb ischemia. Because nonhealing infected ulcers often lead to leg amputation, successful vascular regeneration may delay or prevent amputation. The first phase of the trial is expected to conclude in approximately 1 year.
[black up pointing small triangle] Information:http://ww.aastrom.com