Skin WoundsNCT01722929
Study of Skin and Muscle Parameters Using a Skin Sensor
A study testing Skin sensor in people with Skin Wounds, run by Northwestern University at 1 site in United States.
Trial summary
The aim of this study is to assess the role of skin sensors in obtaining reliable and accurate serial measurements of skin parameters in the context of cutaneous skin wound healing. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Wounds
- What is being tested?
- Skin sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2013to 16 Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and Females age 18 and over
- Recent (post-operative day 0-90) skin surgery of the trunk,extremities, head or neck for minor skin problems resulting in sutured wounds or open granulating wounds.
- Otherwise good general health as assessed by the investigator
- The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.
Who cannot join
- Under 18 years of age
- Pregnancy or Lactation
- Subjects who are unable to understand the protocol or to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: A Pilot Study of Skin and Muscle Parameters Using a Multifunctional Skin Sensor
The aim of this study is to assess the role of skin sensors in obtaining reliable and accurate serial measurements of skin parameters in the context of cutaneous skin wound healing.
- Conditions
- Skin Wounds
- Being tested
- Skin sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin sensorDevice
| Study group | Role | What they receive |
|---|---|---|
| Skin sensor on surgery side | Experimental | Skin sensor will be placed on the side that had surgery. This is split-body, interventional, parallel-design study. All participants will have the skin sensor measured twice on their bodies: on the side with surgery and a contralateral, control site of the body. Receives: Device: Skin sensor |
| Skin sensor on non-surgery side | Active comparator | Skin sensor will be placed on the contralateral side from surgery site.This is split-body, interventional, parallel-design study. All participants will have the skin sensor measured twice on their bodies: on the side with surgery and a contralateral, control site of the body. Receives: Device: Skin sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure Temperature at 3 Time Points
Measured: Baseline, 48 hours from baseline, and 2 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study start4 Jun 2013
- Primary completion16 Sep 2013
- Study completion16 Sep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin WoundsStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants had the skin sensor measure temperature both near a surgery site and also near a non-surgery site. There is one intervention (skin sensor) and the participants were assigned to both arms "surgery side" and "non-surgery side" in parallel.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722929
- Sponsor's protocol ID
- STU69718
- Status last verified
- Dec 2021
- First submitted
- 5 Nov 2012
- Last updated
- 6 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Skin and Muscle Parameters Using a Multifunctional Skin Sensor
- ClinicalTrials.gov ID
- NCT01722929
- Acronym / sponsor ID
- STU69718
- Conditions
- Skin Wounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 4 Jun 2013 (actual)
- Primary completion
- 16 Sep 2013 (actual)
- Study completion
- 16 Sep 2013 (actual)
- First posted
- 7 Nov 2012 (estimated)
- Results
- Posted 4 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess the role of skin sensors in obtaining reliable and accurate serial measurements of skin parameters in the context of cutaneous skin wound healing.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants had the skin sensor measure temperature both near a surgery site and also near a non-surgery site. There is one intervention (skin sensor) and the participants were assigned to both arms "surgery side" and "non-surgery side" in parallel.
| Arm | Type | Receives |
|---|---|---|
| Skin sensor on surgery side | Experimental | Device: Skin sensorSkin sensor will be placed on the side that had surgery. This is split-body, interventional, parallel-design study. All participants will have the skin sensor measured twice on their bodies: on the side with surgery and a contralateral, control site of the body. |
| Skin sensor on non-surgery side | Active comparator | Device: Skin sensorSkin sensor will be placed on the contralateral side from surgery site.This is split-body, interventional, parallel-design study. All participants will have the skin sensor measured twice on their bodies: on the side with surgery and a contralateral, control site of the body. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and Females age 18 and over
- Recent (post-operative day 0-90) skin surgery of the trunk,extremities, head or neck for minor skin problems resulting in sutured wounds or open granulating wounds.
- Otherwise good general health as assessed by the investigator
- The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.
Key exclusion criteria (3 listed)
- Under 18 years of age
- Pregnancy or Lactation
- Subjects who are unable to understand the protocol or to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin sensor | Device | Skin sensor on non-surgery side, Skin sensor on surgery side |
Primary outcome
Measure Temperature at 3 Time Points
Time frame: Baseline, 48 hours from baseline, and 2 weeks from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Skin Wounds
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
RecruitingPhase 2
Superoxide Dismutase Skin Spray for the Prevention of Acute Radiation Dermatitis in Head and Neck Cancer
Radiation-induced Dermatitis
Not yet recruitingObservational study
Determinants of Radiation Dermatitis in Head and Neck Cancer Patients Receiving Preventive Photobiomodulation
Head and Neck Neoplasms, Radiodermatitis
RecruitingPhase 3
S1501 Dual Observational and Randomized Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity
Cardiotoxicity, HER2/Neu Positive
Not yet recruiting
Artificial Intelligence Powered Digital Education Based on the Neuman Systems Model for Breast Cancer Patients Receiving Radiotherap
Breast Cancer, Radiodermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin sensor in people with Skin Wounds, run by Northwestern University 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 6 Dec 2021. 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?
Yes. Results are posted in the registry (first posted 4 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Measure Temperature at 3 Time Points (time frame: Baseline, 48 hours from baseline, and 2 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2021.