Clinical trial NCT01101854: Gene Expression Profiles in Healing and Non-Healing Wounds
Official title: Gene Expression Profiles in Healing and Non-Healing Wounds
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Wounds and Injuries
Keywords: gene expression in wounds
healing wounds
non-healing wounds
punch biopsy
debridement
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2010-04-12
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility 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

Primary outcomes:
measure: Gene Expression Profiles
timeFrame: 12 weeks
Secondary outcomes:
measure: Wound microbiome in healing and non-healing wounds
timeFrame: 12 weeks
measure: Wound area at baseline vs 12 weeks
timeFrame: 12 weeks
measure: Ultrasound images (per availability)
timeFrame: 12 weeks
measure: Histopathological analysis in healing vs non-healing wounds
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Health Methodist Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Gayle Gordillo, MD
role: PRINCIPAL_INVESTIGATOR
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