Diabetic FootNCT00759889
Obtaining and Storing Standard of Care Wound Biopsies for Immediate or Future Wound-Related Scientific Study
An observational study of Diabetic Foot and Leg Ulcer, run by Southwest Regional Wound Care Center at 1 site in United States.
Trial summary
The objective of this study protocol is to use wound biopsies that have been obtained during standard of care management for further scientific evaluation after standard evaluation by a pathologist. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot, Leg Ulcer, Decubitus Ulcer
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to 30 Dec 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Wound edge biopsies that are obtained through standard of care protocols will be subjected to additional microscopic and molecular analyses following the completion of standard medical assessment.
Who may be able to join
- The subject must have a wound, which requires a biopsy for at least one of the following reasons:
- The wound is clinically suspicious (raised fibrotic edges, patchy discoloration of the edges, "invasive appearance", or an appearance substantially different from normal chronic wound appearance).
- The wound has been present for over 3 months that has been under standard of care management for at least 1 month and shows no progression towards healing. No progression towards healing is defined as less than 20% reduction in the size of the wound over a 2-week period of time.
- The subject must be at least 18 years of age.
- The ulcer to be biopsied must be greater than 3 centimeters in area.
Who cannot join
- Unacceptable risk of bleeding as determined by the investigator.
- Medical or emotional risk associated with the potential biopsy that outweighs the risk of not taking a biopsy as determined by the investigator.
- Note: Vulnerable populations will not be excluded from the study as they are over represented in the chronic wound population, but care will be taken to explain the study to family members and caretakers and other stakeholders in the subject's care, so that concerned parties are in agreement as to the subject's enrollment in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southwest Regional Wound Care Center
Lubbock, Texas, 79410
About this study
Official title: Obtaining and Storing Standard of Care Wound Biopsies for Immediate or Future Wound Related Scientific Study
The objective of this study protocol is to use wound biopsies that have been obtained during standard of care management for further scientific evaluation after standard evaluation by a pathologist. Further imaging and molecular analyses would closely evaluate the presence, architecture, and interaction of wound biofilm and human host tissues.
Read the detailed description
The criteria for considering a wound biopsy in a given patient are a chronic wound (venous leg ulcer, diabetic foot ulcer, decubitus ulcer) that has been present for over two (2) months and has failed to progress towards healing (less than 20% decrease in size over 2-week period of time). Also any suspicious wound in which cancer is strongly considered on a clinical basis should be biopsied immediately without any arbitrary timeline being imposed.
- Conditions
- Diabetic Foot, Leg Ulcer, Decubitus Ulcer
- Keywords
- venous leg ulcer
- Medical subject headings
- Diabetic Foot, Leg Ulcer, Pressure Ulcer, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| wound biopsy | diabetic foot,venous leg ulcer, decubitus ulcer |
What is being measured
The primary outcome is the main question the study is designed to answer.
To analyze and image wounds using microscopy and molecular techniques
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startMar 2007
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- 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
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southwest Regional Wound Care Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randall Wolcott, Southwest Regional Wound Care Center
- Investigators
- Randall Wolcott, MD, Principal investigator, Southwest Regional Wound Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759889
- Sponsor's protocol ID
- 56-RW-005
- Status last verified
- Jan 2019
- First submitted
- 24 Sep 2008
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obtaining and Storing Standard of Care Wound Biopsies for Immediate or Future Wound Related Scientific Study
- ClinicalTrials.gov ID
- NCT00759889
- Acronym / sponsor ID
- 56-RW-005
- Conditions
- Diabetic Foot, Leg Ulcer, Decubitus Ulcer
- Keywords
- venous leg ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Southwest Regional Wound Care CenterUniversity, hospital or other
- Study start
- Mar 2007 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 25 Sep 2008 (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.
The objective of this study protocol is to use wound biopsies that have been obtained during standard of care management for further scientific evaluation after standard evaluation by a pathologist. Further imaging and molecular analyses would closely evaluate the presence, architecture, and interaction of wound biofilm and human host tissues.
Detailed description
The criteria for considering a wound biopsy in a given patient are a chronic wound (venous leg ulcer, diabetic foot ulcer, decubitus ulcer) that has been present for over two (2) months and has failed to progress towards healing (less than 20% decrease in size over 2-week period of time). Also any suspicious wound in which cancer is strongly considered on a clinical basis should be biopsied immediately without any arbitrary timeline being imposed.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| wound biopsy | – | –diabetic foot,venous leg ulcer, decubitus ulcer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Wound edge biopsies that are obtained through standard of care protocols will be subjected to additional microscopic and molecular analyses following the completion of standard medical assessment.
Key inclusion criteria (5 listed)
- The subject must have a wound, which requires a biopsy for at least one of the following reasons:
- The subject must be at least 18 years of age.
- The ulcer to be biopsied must be greater than 3 centimeters in area.
Key exclusion criteria (3 listed)
- Unacceptable risk of bleeding as determined by the investigator.
- Medical or emotional risk associated with the potential biopsy that outweighs the risk of not taking a biopsy as determined by the investigator.
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
To analyze and image wounds using microscopy and molecular techniques
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
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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.
Randall Wolcott, MD principal investigator
Southwest Regional Wound Care Center
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 Diabetic Foot and Leg Ulcer, run by Southwest Regional Wound Care Center at 1 site in United States.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 14 Jan 2019. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To analyze and image wounds using microscopy and molecular techniques (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 14 Jan 2019.