We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Information provided by (Responsible Party):

Study Description
Brief Summary:
  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

Condition or disease
Wound Diabetes Amputation

Detailed Description:

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 Design

Study Type : Observational
Estimated Enrollment : 50 participants
Time Perspective: Prospective
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
Groups and Cohorts

Outcome Measures

Biospecimen Retention:   Samples With DNA
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.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   10 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00840164

Contact: Jung-Hsien Hsieh 886-2-23123456 ext 2499 jhhsieh@ntuh.gov.tw

Plasty surgery department, National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Principal Investigator: Jung-Hsien Hsieh         
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Jung-Hsien Hsieh Plasty surgery department, National Taiwan University Hospital
More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00840164     History of Changes
Other Study ID Numbers: 200812048R
First Posted: February 10, 2009    Key Record Dates
Last Update Posted: October 17, 2011
Last Verified: August 2011

Keywords provided by National Taiwan University Hospital:
small-fiber sensory neuropathy
nerve pathology
vasculature pathology
diabetic foot wound
sensory neuropathy
below knee amputation

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases