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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00759889
Other study ID # 56-RW-005
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2007
Est. completion date December 30, 2018

Study information

Verified date January 2019
Source Southwest Regional Wound Care Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. Further imaging and molecular analyses would closely evaluate the presence, architecture, and interaction of wound biofilm and human host tissues.


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date December 30, 2018
Est. primary completion date December 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Southwest Regional Wound Care Center Lubbock Texas

Sponsors (1)

Lead Sponsor Collaborator
Southwest Regional Wound Care Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To analyze and image wounds using microscopy and molecular techniques 1 year
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