Brooks B, Dean R, Patel S, Wu B, Molyneaux L, Yue DK TBI or not TBI: that is the question. Is it better to measure toe pressure than ankle pressure in diabetic patients? Diabet Med. 2001 Jul;18(7):528-32. doi: 10.1046/j.1464-5491.2001.00493.x.
Disa JJ, Carlton JM, Goldberg NH Efficacy of operative cure in pressure sore patients. Plast Reconstr Surg. 1992 Feb;89(2):272-8. doi: 10.1097/00006534-199202000-00012.
FDA Wound Healing Clinical Focus Group . Guidance for industry: chronic cutaneous ulcer and burn wounds-developing products for treatment. Wound Repair Regen. 2001 Jul-Aug;9(4):258-68. doi: 10.1046/j.1524-475x.2001.00258.x. No abstract available.
Goodman CM, Cohen V, Armenta A, Thornby J, Netscher DT Evaluation of results and treatment variables for pressure ulcers in 48 veteran spinal cord-injured patients. Ann Plast Surg. 1999 Jun;42(6):665-72. doi: 10.1097/00000637-199906000-00015.
Lopez D, Vlamakis H, Kolter R Generation of multiple cell types in Bacillus subtilis. FEMS Microbiol Rev. 2009 Jan;33(1):152-63. doi: 10.1111/j.1574-6976.2008.00148.x. Epub 2008 Nov 19.
Park SC, Choi CY, Ha YI, Yang HE Utility of Toe-brachial Index for Diagnosis of Peripheral Artery Disease. Arch Plast Surg. 2012 May;39(3):227-31. doi: 10.5999/aps.2012.39.3.227. Epub 2012 May 10.
Pinnagoda J, Tupker RA, Agner T, Serup J Guidelines for transepidermal water loss (TEWL) measurement. A report from the Standardization Group of the European Society of Contact Dermatitis. Contact Dermatitis. 1990 Mar;22(3):164-78. doi: 10.1111/j.1600-0536.1990.tb01553.x.
Romanos MT, Raspovic A, Perrin BM The reliability of toe systolic pressure and the toe brachial index in patients with diabetes. J Foot Ankle Res. 2010 Dec 22;3:31. doi: 10.1186/1757-1146-3-31.
Roy S, Patel D, Khanna S, Gordillo GM, Biswas S, Friedman A, Sen CK Transcriptome-wide analysis of blood vessels laser captured from human skin and chronic wound-edge tissue. Proc Natl Acad Sci U S A. 2007 Sep 4;104(36):14472-7. doi: 10.1073/pnas.0706793104. Epub 2007 Aug 29.
Thiele JJ, Traber MG, Packer L Depletion of human stratum corneum vitamin E: an early and sensitive in vivo marker of UV induced photo-oxidation. J Invest Dermatol. 1998 May;110(5):756-61. doi: 10.1046/j.1523-1747.1998.00169.x.
Thiele JJ, Traber MG, Polefka TG, Cross CE, Packer L Ozone-exposure depletes vitamin E and induces lipid peroxidation in murine stratum corneum. J Invest Dermatol. 1997 May;108(5):753-7. doi: 10.1111/1523-1747.ep12292144.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
