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SmokingNCT04870970

The Effect of Tobacco Products on Wound Healing

An observational study of Smoking and Tobacco Use, run by University of Minnesota at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking, Tobacco Use, Tobacco Smoking
How many people
60 participants
Where
1 siteUnited States
Study dates
18 May 2021to Feb 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Participants must be enrolled in an ongoing study for participation in this sub-study or meet the inclusion/exclusion criteria for participants not enrolled in an active study.

Who may be able to join

  • In good physical health with no unstable or serious medical conditions as determined by the licensed medical professional;
  • In stable and good mental health (i.e. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis, including substance abuse) as determined by the licensed medical professional;
  • The remaining inclusion criteria is different depending on the type of tobacco product the individual uses:
  • Non Smokers
  • Has consumed less than 100 cigarettes in his or her lifetime.
  • Combustible Tobacco Users
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  • History of at least 5 years smoking
  • Smokers will have exclusively smoked at least 5 cigarettes per day for a minimum of 4 days per week for the past year
  • E-Cigarette Users
  • Have not smoked cigarettes in the last month
  • Has exclusively used e-cigarettes for at least 3 months
  • Has at least 5 instances of using an e cigarettes per day for a minimum of 4 days per week
  • Medicinal Nicotine Users
  • Have not smoked cigarettes in the last month
  • Has at least 5 instances of using medicinal nicotine per day for a minimum of 4 days per week
  • Smokeless Tobacco Users
  • Have not smoked cigarettes in the last month
  • Has at least 5 instances of using smokeless tobacco per day for a minimum of 4 days per week
  • Combustible Tobacco and E-Cigarette Dual Users
  • Has used a combination of combustible tobacco products and e-cigarettes for the past month.
  • Has at least 5 instances of using a combination of combustible tobacco and e-cigarettes per day for a minimum of 4 days per week
  • Combustible Tobacco and Medicinal Nicotine Dual Users
  • Has used a combinations of combustible tobacco products and e-cigarettes for the past month.
  • Has at least 5 instances of using a combination of combustible tobacco and medicinal nicotine per day for a minimum of 4 days per week
  • 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):
  • 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.
  • 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
  • History of smoking at least 10 cigarettes per day;
  • Quitting over 1 year ago
  • NEVER SMOKERS

Who cannot join

  • 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.
  • Intention to quit normal tobacco product use in the next three months.
  • Excessive drinking (more than 21 alcoholic drinks per week)
  • Taking exclusionary medications (including anti-inflammatory agents) unstable dosing of medications, or unstable control of symptoms for ongoing medical conditions (medications or conditions that would impact biomarkers or patient safety to be determined by the licensed medical professional at each site).
  • Active infection (e.g., influenza, cold, respiratory infection, sinus infection), admission to study will be delayed pending improved health;
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  • 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
  • Pregnant or breastfeeding or plans to become pregnant
  • For participants enrolled in an active Tobacco Research Programs study:
  • 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
  • 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
  • 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:
  • <!-- -->
  • Hemoglobin ≥ 9 g/dL for women, ≥ 10 g/dL for men
  • Platelet count ≥ 100 x 109/L
  • Total bilirubin ≤ Institutional upper limit of normal (≤ 1.3 mg/dL for UMMC)
  • ALT ≤ 1.5 times institutional upper limit of normal
  • Creatinine ≤ 1.4 g/dL and estimated GFR ≥ 80 mL/min/1.7m2
  • 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
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Minnesota

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

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.

Read the 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:
  2. Thermography,
  3. Clinical assessment,
  4. Laser Doppler Technologies,
  5. Transcutaneous oxygen assessment
  6. Biological wound inflammation as assessed by:
  7. Cytokine profiles,
  8. Histology,
  9. Genetic assessment,
  10. Epigenetic evaluation
  11. Systemic inflammation as assessed by:
  12. Biomarkers,
  13. Cell counts
Keywords
Wound healing
Medical subject headings
Smoking, Tobacco Use, Tobacco Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04870970
Study groupRoleWhat they receive
Tobacco UsersParticipants in this group use some form of tobacco.
Non-Tobacco UsersParticipants in this group do not use tobacco products.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cutaneous temperature

    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.

    Measured: approximately 7 days

  2. Cutaneous perfusion

    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."

    Measured: approximately 7 days

  3. Cutaneous oxygenation

    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.

    Measured: approximately 7 days

  4. Immunohistochemistry - markers of inflammation

    CD31 and C68 are stained via standard immunohistochemistry methods on punch biopsied specimens. Unit of measure is cell count.

    Measured: approximately 7 days

  5. Biological Wound Inflammation

    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.

    Measured: approximately 7 days

  6. Tumor necrosis factor (TNF)-alpha

    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.

    Measured: approximately 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2021
  2. Study start18 May 2021
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04870970
Sponsor's protocol ID
STUDY00006048
Status last verified
Feb 2026
First submitted
28 Apr 2021
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Smoking and Tobacco Use, run by University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cutaneous temperature (time frame: approximately 7 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04870970.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.

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