The Effect of Tobacco Products on Wound Healing

Active, not recruiting

• Conditions: Smoking; Tobacco Smoking; Tobacco Use

• Registration Number: NCT04870970
• Lead Sponsor: University of Minnesota

Brief Summary

The purpose of this study is to evaluate the effect of various tobacco products (including but not limited to combustible cigarettes, medicinal nicotine, electronic cigarettes, and smokeless tobacco) on cutaneous wound healing. There will also be a non- smoking control group. This study will be designed as a pilot study. The majority of individuals will be recruited from ongoing studies at the University of Minnesota - Tobacco Research Programs.

Detailed Description

Participants will be recruited from ongoing studies will some recruitment of tobacco users and non-smoking controls outside of ongoing studies. In this prospective, cohort study of various tobacco users and non-smokers, a punch biopsy model of wound healing will be used to determine the effects of various tobacco products on inflammatory response and oxidative stress response to wounding:

1. Clinical wound inflammation as assessed by:

1. Thermography,

2. Clinical assessment,

3. Laser Doppler Technologies,

4. Transcutaneous oxygen assessment

2. Biological wound inflammation as assessed by:

1. Cytokine profiles,

2. Histology,

3. Genetic assessment,

4. Epigenetic evaluation

3. Systemic inflammation as assessed by:

1. Biomarkers,

2. Cell counts

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-05-04
• Study Start: 2021-05-18
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20
• Primary Completion: 2027-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Concurrent enrollment in one of the following studies (if the study is registered with clinicaltrials.gov, please click the link to see inclusion/exclusion criteria):

A) Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace - https://clinicaltrials.gov/ct2/show/NCT03272685 B) Clinical trial to assess the removal of filter ventilation on smoking behavior and biomarkers - https://clinicaltrials.gov/ct2/show/NCT03637972 C) e-Cigarettes: Formaldehyde DNA Adducts, Oxidative Damage, and Potential Toxicity and Carcinogenesis - https://clinicaltrials.gov/ct2/show/NCT03284632 D) Methodology and Development of Tobacco Related Biomarkers, part of "Metabolism of Carcinogenic Tobacco-Specific Nitrosamines" Inclusion Criteria - Generally good physical and mental health as evidenced by a medical history with no unstable medical conditions and study physician approval.

Exclusion Criteria

• Pregnant or breastfeeding or plans to become pregnant

• Regular use of other tobacco or smoked products (e.g., cigars, pipes, smokeless tobacco, marijuana) in past 6 months;
• Active infection (e.g., influenza, cold, respiratory infection, sinus infection), admission to study will be delayed pending improved health;
• Unstable medical or psychiatric condition

SMOKERS

Inclusion:

• Currently smoking at least 10 cigarettes per day;

• History of at least 5 years smoking;

• Stable smoking pattern for the past 1 year (<50% change in brand or number of cigarettes smoked).

FORMER SMOKERS

Inclusion:

• History of smoking at least 10 cigarettes per day;
• Quitting over 1 year ago

NEVER SMOKERS

Exclusion:

• Smoking more than 100 cigarettes in their lifetime

NICOTINE REPLACEMENT USERS

• Inclusion/Exclusion dependent on intended sample use

E-CIGARETTE USERS (Addendum study) - Inclusion/Exclusion dependent on intended sample use

SMOKELESS TOBACCO USERS (Addendum study)

• Inclusion/Exclusion dependent on intended sample use

E) Clinical Trial of Watercress in Detoxification of Environmental Toxicants and Carcinogens - https://clinicaltrials.gov/ct2/show/NCT03978117 F) Metabolism of Deuterated NNN in Smokeless Tobacco Users - https://clinicaltrials.gov/ct2/show/NCT02414477 G) Biomarkers of Exposure and Effect in SREC Users - https://clinicaltrials.gov/ct2/show/NCT04003805 H) Nornicotine in Smokeless Tobacco as a Precursor for Carcinogen Exposure - https://www.clinicaltrials.gov/ct2/show/NCT03998735 I) Phase 1 Trial of Indole-3-Carbinol and Silibinin Inclusion Criteria

• Current smoker of ≥ 8 cigarettes per day for at least the last 6 months by self-report

Adequate blood counts, and adequate liver and kidney function defined as follows:

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1. Hemoglobin ≥ 9 g/dL for women, ≥ 10 g/dL for men

2. Platelet count ≥ 100 x 109/L

3. Total bilirubin ≤ Institutional upper limit of normal (≤ 1.3 mg/dL for UMMC)

4. ALT ≤ 1.5 times institutional upper limit of normal

5. Creatinine ≤ 1.4 g/dL and estimated GFR ≥ 80 mL/min/1.7m2

   Exclusion Criteria

   • Daily proton pump inhibitor, H2-blocker (i.e., ranitidine, famotidine), and/or calcium carbonate use

   • History of gastric bypass surgery, gastric banding, bowel resection, malabsorption syndromes such as celiac sprue or pancreatic insufficiency, or other conditions that may affect gastric or intestinal absorption of nutrients

   • Use of tobacco products other than cigarettes (i.e. snuff, snuz, smokeless tobacco, cigars, pipes), within 7 days of study registration

   • Major or chronic medical disease, including heart disease, poorly controlled diabetes, etc., to be adjudicated by the principal investigator
   • Known active malignancy
   • History of aerodigestive malignancies
   • Pregnancy, intension to become pregnant within 3 months of study registration, or lactation. Participants of childbearing potential must have a negative urine pregnancy test within 14 days of starting the assigned intervention
   • Antibiotic use within 2 months of study registration by self-report
   • History of respiratory tract cancer
   • Known allergy to I3C, Sil, or its components
   • Psychiatric and/or social situations that would potentially limit compliance with study requirements

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Exclusion Criteria

• Any tattoos on the medial upper arm (note that one medial upper arm can have a tattoo, but at least one side does not have a tattoo).

  • History of delayed wound healing.
  • Additional exclusion criteria for those undergoing the additional Laser Doppler Technologies
  • Individuals with extremely sensitive skin that may feel the 45 degrees Celsius is too warm

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunohistochemistry - markers of inflammation	approximately 7 days	CD31 and C68 are stained via standard immunohistochemistry methods on punch biopsied specimens. Unit of measure is cell count.
Cutaneous temperature	approximately 7 days	Cutaneous temperature is measured using in infrared thermographic camera (FLIR T460 Infrared Thermal Imaging Camera, FLIR Systems, Inc., Wilsonville, OR). Images will be analyzed using a camera-specific software (FLIR Tools) that interrogates cutaneous temperature points of the image. The units are software-determined, arbitrary units that are standardized within the FLIR imaging system but do not correspond to standard units of measure.
Cutaneous perfusion	approximately 7 days	Cutaneous perfusion is measured using Laser Doppler Technologies (PeriFlux 6000, Perimed AB, Stockholm, Sweden). Tissue oxygenation is measured in the capillaries only. Perfusion is measured in arbitrary system defined "perfusion units."
Cutaneous oxygenation	approximately 7 days	Cutaneous oxygenation is measured using Laser Doppler Technologies (PeriFlux 6000, Perimed AB, Stockholm, Sweden). Tissue oxygenation is measured in the capillaries only. Oxygenation is measured in mmHg.
Biological Wound Inflammation	approximately 7 days	IL-1b, 6 and 10 are measured using standard immunoassays and reported in units of pg/ml. These cytokines will be measured in both the skin and blood.
Tumor necrosis factor (TNF)-alpha	approximately 7 days	TNF-alpha is measured using standard immunoassays and reported in units of pg/ml. This cytokine will be measured in both the skin and blood.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States