The Effect of Tobacco Products on Wound Healing

Running, not enrolling

Conditions studied: Smoking, Tobacco Use, Tobacco Smoking

In brief

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.

Key facts

Study ID: NCT04870970
Run by: University of Minnesota
People needed: 60
Starts: 2021-05-18
Expected to finish: 2027-02-01
Last updated by the study team: 2026-02-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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:
A) Non Smokers
Has consumed less than 100 cigarettes in his or her lifetime.
Combustible Tobacco Users
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
B) 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
C) 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
D) 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
E) 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
F) 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

You may not qualify if…

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;
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:
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:

Where it is running

University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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