Pathology of Skin, Nerve and Vasculature in the Amputated Limb of Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00840164
First received: February 8, 2009
Last updated: October 13, 2011
Last verified: August 2011

February 8, 2009
October 13, 2011
February 2009
December 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00840164 on ClinicalTrials.gov Archive Site
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Pathology of Skin, Nerve and Vasculature in the Amputated Limb of Diabetes
Pathology of Skin, Nerve and Vasculature in the Amputated Limb of Diabetes
  1. To explore the pathology of nerve, vascular, and skin in the amputated leg
  2. To diagnose small-fiber sensory neuropathy of the contralateral leg by investigating the skin intervention
  3. To search for (1) mechanisms of amputation and (2) prevention measures for further amputation in the currently healthy-looking limb

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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

After amputation, sural nerve, posterior tibial nerve, and the accompanying vasculature will be harvested from the amputated leg. 3mm-puch skin will be taken from the amputated leg, 10 cm above the lateral malleolus.

Non-Probability Sample

Diabetic foot wound patient who underwent below-knee amputation due to poor wound healing and severe infection condition. The patient population often receives leg revasculariztion surgery but poor response for wound healing.

  • Wound
  • Diabetes
  • Amputation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2013
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diabetic foot wound patient who underwent below-knee amputation

Exclusion Criteria:

  • Diabetic foot wound patient who couldn't receive below-knee amputation due to severe heart disease, high anesthetic risk.
Both
10 Years to 90 Years
No
Contact: Jung-Hsien Hsieh 886-2-23123456 ext 2499 jhhsieh@ntuh.gov.tw
Taiwan
 
NCT00840164
200812048R
No
National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Jung-Hsien Hsieh Plasty surgery department, National Taiwan University Hospital
National Taiwan University Hospital
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP