Pathology of Skin, Nerve and Vasculature in the Amputated Limb of Diabetes
|ClinicalTrials.gov Identifier: NCT00840164|
Recruitment Status : Unknown
Verified August 2011 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : February 10, 2009
Last Update Posted : October 17, 2011
- To explore the pathology of nerve, vascular, and skin in the amputated leg
- To diagnose small-fiber sensory neuropathy of the contralateral leg by investigating the skin intervention
- To search for (1) mechanisms of amputation and (2) prevention measures for further amputation in the currently healthy-looking limb
|Condition or disease|
|Wound Diabetes Amputation|
Diabetic foot occurs in 15% of diabetic population (3) and 15% of the diabetic foot patients end up with lower limb amputation. Peripheral neuropathy (sensory, motor and autonomic), peripheral vascular disease, trauma, infection and poor wound healing all contribute to diabetic foot problem.
Peripheral neuropathy could be evaluated in a variety of ways, including vibratory thresholds, thermal thresholds, pressure perception thresholds, muscle strength. All these predict foot ulceration to some degree(1). Motor nerve conduction velocity is an independent predictor for the development of new foot ulcer in diabetic population.
For more detailed structural study of neuropathy in diabetic patient, we could use skin biopsy method. Skin biopsy with PGP9.5 immunohistochemistry has been demonstrated by ultrastructural studies to label the terminal portions of both small myelinated and unmyelinated nerve in the epidermis . Intra-epidermal nerve fiber (IENF) density is reduced in patient with impaired glucose tolerance and clinically overt diabetes . Previous IENF density study was performed in diabetic patients with sensory symptom but no foot ulcer. Now we tried to evaluate IENF density in severe diabetic foot patient who received below knee amputation. Skin biopsy willl be performed at amputated leg. The skin biopsy area will be located at lateral side of distal leg, 10 cm above the lateral malleolus as previous protocol of our group . Underlying sural nerve and posterior tibial nerve will be also harvested for further ultra-structural study. The result will be compared to the control group which were recruited from a previously described cohort matched by gender and age.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Pathology of Skin, Nerve and Vasculature in the Amputated Limb of Diabetes|
|Study Start Date :||February 2009|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||December 2013|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00840164
|Contact: Jung-Hsien Hsieh||886-2-23123456 ext firstname.lastname@example.org|
|Plasty surgery department, National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 100|
|Principal Investigator: Jung-Hsien Hsieh|
|Principal Investigator:||Jung-Hsien Hsieh||Plasty surgery department, National Taiwan University Hospital|