Obtaining and Storing Standard of Care Wound Biopsies for Immediate or Future Wound-Related Scientific Study

NCT00759889 | Completed DMC

• 1 other identifier: 56-RW-005
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Foot; Leg Ulcer; Decubitus Ulcer

Keywords

venous leg ulcer

Outcome Measures

Primary Outcomes (1)

• To analyze and image wounds using microscopy and molecular techniques

  1 year

Study Arms (1)

wound biopsy

diabetic foot,venous leg ulcer, decubitus ulcer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southwest Regional Wound Care Center: lead

Study Sites (1)

Southwest Regional Wound Care Center

Lubbock, Texas, 79410, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Diabetic Foot; Leg Ulcer; Pressure Ulcer; Varicose Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins

Study Officials

• Randall Wolcott, MD

  Southwest Regional Wound Care Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 25, 2008
• Study Start: March 1, 2007
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: January 14, 2019

Record last verified: 2019-01

Locations

US (1)