NCT04870970|Active Not Recruiting
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Sponsor study identifier
observational
60
1 country
1
Study Start
May 18, 2021
Actual (reported)Primary Completion
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 28, 2021
Actual (reported)May 4, 2021
Actual (reported)May 18, 2021
Actual (reported)February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
approximately 7 days
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."
approximately 7 days
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.
approximately 7 days
Participants in this group use some form of tobacco.
Participants in this group do not use tobacco products.
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.
University of Minnesota
Minneapolis, Minnesota, 55455, United States
A separate electronic consent form will be used to allow the use of specimens collected (both blood and tissue) for genetic research. Participants can decline the use of their specimens for genetic research but may not be able to participate in the study. The study coordinator will keep a log through REDCap of which participants declined the use of their samples for genetic research to ensure those samples will not be used for genetic research. Participants will also have the option to allow the future use of their de-identified specimens collected for general research, including genetic purposes.
Dorothy Hatsukami, PhD
University of Minnesota
60 participants (actual enrollment reported by the registry).
First Submitted
April 28, 2021
First Posted
May 4, 2021
Study Start
May 18, 2021
Actual (reported)Immunohistochemistry - markers of inflammation
CD31 and C68 are stained via standard immunohistochemistry methods on punch biopsied specimens. Unit of measure is cell count.
approximately 7 days
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.
approximately 7 days
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.
approximately 7 days
Contact the study team to confirm eligibility.
Primary Completion
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 18, 2026
Record last verified: 2026-02
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Source: ClinicalTrials.gov.
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