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Gene Expression Profiles in Healing and Non-Healing Wounds (Gene Screen)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01101854
Recruitment Status : Recruiting
First Posted : April 12, 2010
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Gayle Gordillo, Indiana University

Brief Summary:
The purpose of this study is to develop a database containing information about genes/proteins/fats as well as wound infections in both healing and non-healing wounds. Many wounds that do not heal are infected. This study will help us determine if there is a relationship between the types of infections and how well a wound heals. Identification of genes/proteins/lipids (fats) that help predict wound healing under specific wound healing conditions will enable health care practitioners to select more appropriate treatments, monitor the responses to those treatments, and figure out what standard treatments should be.

Condition or disease
Wounds and Injuries

Detailed Description:

During the first study visit, information about participants, such as age, race and gender, medical history, including nutritional status, medications and dietary supplements, and genetic diseases in the participant's family will be collected. Smoking and tobacco status, alcohol consumption, and/or recreational drugs usage will be documented. Additionally, wound information, including wound measurements, infection history, cause, location, how long you have had the wound, etc, a digital photograph of the wound and ultrasound imaging (if available) will be obtained. Lab results, such as nutrition and blood sugar (if the subject has Diabetes Mellitus) levels will be obtained. If a blood sugar level is not available from the past 3 months, a finger stick will be performed to obtain the participant's hemoglobin A1c level. Lastly, debrided tissue and/or biopsies, wound fluid, and 20 cc of blood will be collected.

During second study visit, a digital image of the wound area will be taken and the wound will be evaluated for clinical signs of infection using a WIfI scale, as appropriate. Any new wound treatments, labs, and adverse events along with changes in medications and medical history since baseline will be documented. Additionally, debrided tissue and/or biopsies, wound fluid, and 20 cc of blood will be collected.

The final stage is the observation phase, which will last up to 12 weeks. The wound closure and/or area data will be recorded from the participant's medical record up to 12 weeks.

Potential Risks:

Biopsy and Debridement:

There may be some discomfort with the tissue biopsy procedure depending on the amount of sensation the subject has at the site of the wound. The wound site will be numbed by applying local anesthesia as appropriate to area being biopsied. The amount of pain that occurs with wound biopsy will vary from person to person, but all reasonable efforts will be made to minimize pain. The biopsy procedure is done within the boundaries of the existing wound to avoid giving the patient a separate new wound. Bleeding is a possible complication, but the risk is low for the small biopsies and is reduced by using local anesthetics with epinephrine, and silver nitrate sticks are available in each room to cauterize biopsy sites as needed. Infection is also a potential risk; however, wound tissue biopsies are routinely performed as the standard of care in the CWC to diagnose wound infection. The biopsy site will be appropriately monitored for infection by the provider managing the wound during routine wound clinic visits. No additional study specific risk is identified for debrided tissue as the procedure is performed as part of SoC.

Blood Draw:

Temporary discomfort from the needle stick, bruising, bleeding, and rarely, infection. To reduce the risk of infection, the research personnel will clean subject's arm with an antiseptic solution before any blood is drawn.

Hemoglobin A1c point-of-care testing:

The point-of-care testing for hemoglobin A1c test is low risk. Potential risks include minor and temporary pain or discomfort and bleeding. Prior to the finger prick, research staff will clean the finger to be pricked with an alcohol swab. Subjects will be provided with a cotton ball and/or band-aid to stop the bleeding, if there is any.

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gene Expression Profiles in Healing and Non-Healing Wounds
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Gene Expression Profiles [ Time Frame: 12 weeks ]
    A database of gene/protein/lipid expression and wound infection in healing and non-healing wounds.


Secondary Outcome Measures :
  1. Wound microbiome in healing and non-healing wounds [ Time Frame: 12 weeks ]
  2. Wound area at baseline vs 12 weeks [ Time Frame: 12 weeks ]
  3. Ultrasound images (per availability) [ Time Frame: 12 weeks ]
  4. Histopathological analysis in healing vs non-healing wounds [ Time Frame: 12 weeks ]

Biospecimen Retention:   Samples With DNA
Tissue


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who have a chronic wound(s) (defined as a wound that has been present for at least 4 weeks).
Criteria

Inclusion Criteria:

  • Age: 18 years and above
  • Ulcer duration of > 4 weeks

Exclusion Criteria:

  • Pregnant females
  • Receiving chemotherapy or radiation therapy for cancer
  • Known or suspected malignancy of current study ulcer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101854


Contacts
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Contact: Jennifer Mohacky, RDN (317) 278-2720 jmohnack@iu.edu
Contact: Tammy Garrett, RN (317) 278-2716 tjgarret@iupui.edu

Locations
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United States, Indiana
IU Health Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: Gayle Gordillo, MD         
Sub-Investigator: Chandan Sen, PhD         
Sub-Investigator: Sashwati Roy, PhD         
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Gayle Gordillo, MD Indiana University
Publications:
Efron B, Tibshirani R, Storey JD, Tusher V. Empirical Bayes Analysis of a Microarray Experiment. Journal of the American Statistical Association. 2001; 96(456):1151-1160.

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Responsible Party: Gayle Gordillo, Professor, Indiana University
ClinicalTrials.gov Identifier: NCT01101854    
Obsolete Identifiers: NCT00618189
Other Study ID Numbers: 1906520102
First Posted: April 12, 2010    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gayle Gordillo, Indiana University:
gene expression in wounds
healing wounds
non-healing wounds
punch biopsy
debridement
Additional relevant MeSH terms:
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Wounds and Injuries