WoundNCT00840164
Pathology of Skin, Nerve and Vasculature in the Amputated Limb of Diabetes
An observational study of Wound and Diabetes, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 90 years
- Conditions the study is for
- Wound, Diabetes, Amputation
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2009to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Diabetic foot wound patient who underwent below-knee amputation
Who cannot join
- Diabetic foot wound patient who couldn't receive below-knee amputation due to severe heart disease, high anesthetic risk.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Plasty surgery department, National Taiwan University Hospital
Taipei, 100
Jung-Hsien Hsieh
About this study
- 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
Read the 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.
- Conditions
- Wound, Diabetes, Amputation
- Keywords
- small-fiber sensory neuropathy, nerve pathology, vasculature pathology, amputation, diabetic foot wound, sensory neuropathy, below knee amputation
- Medical subject headings
- Wounds and Injuries, Diabetes Mellitus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jung-Hsien Hsieh, Principal investigator, Plasty surgery department, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840164
- Sponsor's protocol ID
- 200812048R
- Status last verified
- Aug 2011
- First submitted
- 8 Feb 2009
- Last updated
- 17 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathology of Skin, Nerve and Vasculature in the Amputated Limb of Diabetes
- ClinicalTrials.gov ID
- NCT00840164
- Acronym / sponsor ID
- 200812048R
- Conditions
- Wound, Diabetes, Amputation
- Keywords
- small-fiber sensory neuropathy, nerve pathology, vasculature pathology, amputation, diabetic foot wound, sensory neuropathy, below knee amputation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 10 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
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
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Diabetic foot wound patient who underwent below-knee amputation
Key exclusion criteria (1 listed)
- Diabetic foot wound patient who couldn't receive below-knee amputation due to severe heart disease, high anesthetic risk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung-Hsien Hsieh principal investigator
Plasty surgery department, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound and Diabetes, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung-Hsien Hsieh (886-2-23123456 ext. 2499, jhhsieh@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2011.