NCT00840164

Brief Summary

  1. 1.To explore the pathology of nerve, vascular, and skin in the amputated leg
  2. 2.To diagnose small-fiber sensory neuropathy of the contralateral leg by investigating the skin intervention
  3. 3.To search for (1) mechanisms of amputation and (2) prevention measures for further amputation in the currently healthy-looking limb

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

October 17, 2011

Status Verified

August 1, 2011

Enrollment Period

2.8 years

First QC Date

February 8, 2009

Last Update Submit

October 13, 2011

Conditions

WoundDiabetesAmputation

Keywords

small-fiber sensory neuropathynerve pathologyvasculature pathologyamputationdiabetic foot woundsensory neuropathybelow knee amputation

Eligibility Criteria

Age10 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Diabetic foot wound patient who underwent below-knee amputation

You may not qualify if:

  • Diabetic foot wound patient who couldn't receive below-knee amputation due to severe heart disease, high anesthetic risk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Plasty surgery department, National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

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.

MeSH Terms

Conditions

Wounds and InjuriesDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jung-Hsien Hsieh

    Plasty surgery department, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung-Hsien Hsieh

CONTACT

886-2-23123456jhhsieh@ntuh.gov.tw

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2009

First Posted

February 10, 2009

Study Start

February 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2013

Last Updated

October 17, 2011

Record last verified: 2011-08

Locations

TW(1)