This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Diabetic peripheral neuropathy trials have largely relied on the same measurements to determine whether an investigational drug may provide a benefit. These measures include nerve conduction velocity testing and quantitative sensory testing and were historically developed as tools to diagnose peripheral neuropathy as opposed to measuring a drug effect. These measures, while excellent for their intended purpose of diagnosis do not appear to be sensitive to small changes in nerve function as may occur in the setting of a clinical trial. As a result, there is a sense that some trials may have failed not because the drug did not provide a benefit, but rather that investigators were not able to detect those improvements. The nerves in the skin can be reliably measured using punch skin biopsies and are very relevant to diabetes. There is strong evidence that they are often the earliest sign of neuropathy. Furthermore, the biopsy technique gives a direct measure of nerve integrity while other clinical tests extrapolate this information indirectly. Finally, nerves in the skin are easily accessible and by extension can be injured in a standardized, safe and relatively innocuous fashion. This allows the rate of nerve recovery or regeneration to be precisely determined. The purpose of this clinical trial is to determine whether the investigational compound FK1706, is able to accelerate the rate of epidermal nerve fiber regeneration using validated cutaneous nerve injury models. Epidermal innervation is particularly relevant to FK1706 as preclinical studies indicate that the mechanism of action of FK1706 is directed at potentiating the effect of endogenous nerve growth factor (NGF). Cutaneous nerve fibers are among the class of nerve fibers that is responsive to NGF, while large myelinated nerve fibers (those that are primarily tested in nerve conduction velocity and quantitative sensory testing) are unresponsive to NGF's effects.This mutlicenter regenerative diabetic neuropathy study is coordinated through Johns Hopkins and uses models of cutaneous nerve regeneration that have been developed over the past 5 years.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000052-46
Application #
7604685
Study Section
Special Emphasis Panel (ZRR1-CR-1 (01))
Project Start
2006-12-01
Project End
2007-09-16
Budget Start
2006-12-01
Budget End
2007-09-16
Support Year
46
Fiscal Year
2007
Total Cost
$3,376
Indirect Cost
Name
Johns Hopkins University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
Al-Sofiani, Mohammed E; Yanek, Lisa R; Faraday, Nauder et al. (2018) Diabetes and Platelet Response to Low-Dose Aspirin. J Clin Endocrinol Metab 103:4599-4608
Grover, Surbhi; Desir, Fidel; Jing, Yuezhou et al. (2018) Reduced Cancer Survival Among Adults With HIV and AIDS-Defining Illnesses Despite No Difference in Cancer Stage at Diagnosis. J Acquir Immune Defic Syndr 79:421-429
Grams, Morgan E; Sang, Yingying; Ballew, Shoshana H et al. (2018) Predicting timing of clinical outcomes in patients with chronic kidney disease and severely decreased glomerular filtration rate. Kidney Int 93:1442-1451
Yanik, Elizabeth L; Hernández-Ramírez, Raúl U; Qin, Li et al. (2018) Brief Report: Cutaneous Melanoma Risk Among People With HIV in the United States and Canada. J Acquir Immune Defic Syndr 78:499-504
Aboud, Katherine S; Barquero, Laura A; Cutting, Laurie E (2018) Prefrontal mediation of the reading network predicts intervention response in dyslexia. Cortex 101:96-106
Kattan, Meyer; Bacharier, Leonard B; O'Connor, George T et al. (2018) Spirometry and Impulse Oscillometry in Preschool Children: Acceptability and Relationship to Maternal Smoking in Pregnancy. J Allergy Clin Immunol Pract 6:1596-1603.e6
Altekruse, Sean F; Shiels, Meredith S; Modur, Sharada P et al. (2018) Cancer burden attributable to cigarette smoking among HIV-infected people in North America. AIDS 32:513-521
Salemi, Parissa; Skalamera Olson, Julie M; Dickson, Lauren E et al. (2018) Ossifications in Albright Hereditary Osteodystrophy: Role of Genotype, Inheritance, Sex, Age, Hormonal Status, and BMI. J Clin Endocrinol Metab 103:158-168
Robert Braši?, James; Mari, Zoltan; Lerner, Alicja et al. (2018) Remission of Gilles de la Tourette Syndrome after Heat-Induced Dehydration. Int J Phys Med Rehabil 6:
Altman, Matthew C; Whalen, Elizabeth; Togias, Alkis et al. (2018) Allergen-induced activation of natural killer cells represents an early-life immune response in the development of allergic asthma. J Allergy Clin Immunol 142:1856-1866

Showing the most recent 10 out of 1014 publications