Obtaining and Storing Blood Samples and Debridement Samples for Wound Related Research

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00762697

Enrollment

Registered

2008-09-30

Start date

2007-06-30

Completion date

2012-04-30

Last updated

2015-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Insufficiency

Keywords

diabetic, venous insufficiency

Brief summary

The intent of this protocol is to obtain blood samples from subjects with or without a wound, so the blood can be used in wound-related scientific studies. It is also the intent of this protocol to salvage debrided wound material that is normally destined for destruction, so it can be used in wound-related scientific studies.

Detailed description

The samples will be studied in order to attempt to better understand wounds and their associated barriers to healing. Analytical methods used to examine the blood or debridement can investigate morphological, molecular, immunological, cellular, viral, biochemical, chemical, genetic, and/or transcriptional components of the samples. It is the goal of this study to determine if these tests may be able to provide important insights into the keys of wound healing, wound persistence, or wound deterioration.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Inclusion Criteria for the Collection of Wound Debridement 1. The subject must have a full thickness wound. 2. The subject must be a candidate for sharp debridement. 3. The subject must be 18 years of age or older. 4. The subject must be mentally competent as determined by the Investigator Inclusion Criteria for the Collection of Blood Wounded or Otherwise Not Healthy Subjects, Subjects Weighing Less Than 110 lbs., or Subjects Contributing 50ml of Blood or Less: 1. The subject must be 18 years of age or older. 2. The subject must be mentally competent as determined by the Investigator. Not Wounded and Healthy Subjects Weighing at Least 110 lbs. Who May Contribute Up To 500ml of Blood: 1. The subject must be 18 years of age or older. 2. The subject must be mentally competent as determined by the Investigator. 3. The subject must weigh at least 110 lbs. 4. The subject must have a hemoglobin level that is in or above the normal range within the last 8 (eight) weeks as determined by standard clinical laboratory testing, the copper sulfate test, or a point of care instrument.

Countries

United States

Outcome results