Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Clinical Trial 39601

San Antonio, TX 78209


Study Summary:

ICON Early Phase Services is conducting a research study for healthy adults age 18 and older.  This study is being done to collect data on a device designed for wound care.  The wrap-around wound care device will be placed at the knee. There is no investigational drug involved. 


Physical examinations and pregnancy, drug and alcohol screens will be performed. Urine samples will also be obtained during this study. 

Participants will complete:

  •  1 screening visit
  •  4 partial days
  •  14 days at home collecting data
  •  1 follow-up visit

If ICON does not have your medical records on file, you may need to provide medical records.  For more information, see below

 

If you are able to answer “YES” to the following statements, you may qualify for this study.

 

  • I am a healthy adult, meaning no significant medical conditions

 

  • I am age 18 or older

 

  • My BMI is between ≥ 18.0 and ≤ 32.0 kg/m2  and I weigh at least 110 lbs.

 

  • I agree not to smoke while at the clinic and to abide by the rules of the clinic (which is a non-smoking facility)

 

  • I have not participated in another clinical trial within 30 days prior to the first study visit  

 

  • If Female, I am not pregnant or breastfeeding   

 

  • If Female, I am non-fertile or I agree to use birth control during the study through the end of the study visit

 

  • I am willing to have excessive body hair (on the knee test area) removed by surgical clippers  

 

  • I own a smartphone and I am willing to download the FitBit application software to allow for the tracking and download of overall step activity

 

  • I am able to communicate effectively in English with the study personnel

 

  • I agree to avoid activities that require excessive movement, cause excessive sweating, or exposure to water (e.g., contact sports, swimming, aerobics, running)

 

  • I agree to avoid prolonged contact with water at the knee test area for the duration of the study (e.g., soaking in a bathtub or hot tub, long showering, or mud wrestling)

 

  • I agree to avoid using tanning lotions, exposure to ultraviolet radiation from the sun (e.g., sun bathing/beach exposure), or artificial sources (such as a tanning bed) on the knee test area for the duration of the study

 

  • I agree to wear loose clothing for the duration of the study. (NOTE: Leggings, skinny jeans, or other tight clothing, may hinder the device tracking.)

 

  • I do not have a history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease

 

  • I do not have a history or presence of any skin disease that might interfere with the evaluation of the knee test area (e.g, Meleney’s ulcer, scleroderma, chronic urticaria, psoriasis, skin cancer, recurrent skin infection/cellulitis, or malignancy)

 

  • I do not have a history or presence of connective tissue disease or collagen vascular disease (e.g., Ehlers-Danlos syndrome, systemic lupus erythematosus, rheumatoid arthritis)

 

  • I do not have a history or presence of blood disorders or conditions (polycythemia vera, thrombocythemia, thrombocytopenia, sickle cell disease) or an immunosuppressive disorder

 

  • I do not have any condition that can potentially result in abnormal pigmented skin (e.g., melasma, vitiligo, pityriasis rosea, tinea versicolor)

 

  • I do not have pre-existing or dormant skin conditions (e.g., psoriasis, eczema, atopic dermatitis, etc.) near or around the knee test area

 

  • I do not have damaged skin in or around the knee test area (including sunburn, peeling skin, extremely deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, wounds, lesions, severe raised scar tissue, excessive skin folds, or other disfiguration)

 

  • I agree to avoid exposure to ultraviolet radiation from the sun or from artificial sources such as tanning beds on the test area within 14 days prior to study start

 

  • I have not used a topical treatment on the knee test area (e.g., laser hair or tattoo removal, sunless tanning lotion) or used steroid topical treatments within 14 days prior to study start

 

  • I have not used tetracycline or Accutane on the knee test area within 30 days prior to study start

 

  • I have not used oral steroids within 30 days prior to study start. (NOTE: Topical, eye or aerosol steroids are permitted as long as the application area is not on or near the knee test area.)  

 

  • I do not have a history or presence of past cancer requiring immuno-

suppressant therapy or chemotherapy

 

  • I do not have a history or presence of allergic or adverse response to medical adhesive, polyurethane, silver, latex or any related products

 

  • I do not have a history or presence or hypersensitivity or allergy to any of the disposable components of the dressing system (e.g., foam, drape material, or adhesive

 

  • I do not have a history of substance abuse or treatment (including alcohol) within the past 6 months

 

  • I agree not to consume excessive alcohol from 48 hours prior to study start until the end-of-study visit.

 

 

It is important to understand that even if you feel that you meet all the above criteria, you are still required to complete the protocol screening procedures.  Frequently, subjects do not qualify because of medical history or minor changes in vital signs, ECG and lab tests.  Scheduling a screening appointment does not guarantee that you will qualify for that study. Additionally, subjects are screened on a first come-first served basis and studies may complete enrollment prior to your visit.  Additionally, no guarantees can be made regarding group assignments for any particular study.  ICON will not assume any liability for lost time, travel or failure to qualify.

We will be testing for tobacco and drug abuse.  Please refrain from consuming alcohol at least 24 hours prior to your screening appointment. 

Be sure to bring all of your medications with you to your screening appointment. 

Please note, you need to bring a valid, non-expired photo ID and your Social Security Card with you when you attend your screening visit.  We accept a government issued identification card such as a driver's license, state issued ID card, or passport.  Also, be advised that we cannot accept a military ID as we are legally prohibited from copying that form of identification for our records.

You will be filling out paperwork for the study.  Please arrive at least 30 minutes in advance of your screening appointment.  If you are late for your appointment you may not be seen or may need to reschedule. 

Be advised that you may need to provide medical records as part of the screening process for this study.  If possible, please bring your full medical records with you to your screening appointment.  If you cannot bring your records with you, you must provide them before you can admit to the study.  Note that full medical records include surgical reports.  You will not be allowed to participate in the study without medical records defined as:

  • All medical records, including but not limited to: office notes, face sheets, history and physical, consultation notes, inpatient, outpatient and emergency room treatment, all clinical charts, reports, surgical reports, order sheets, progress notes, nurse's notes, social worker records, clinic records, treatment plans, admission records, discharge summaries, reports of consultations, documents, correspondence, test results, statements, questionnaires/histories, from your medical provider(s).
  • For females, surgical reports are required as documentation for procedures such as hysterectomy, bilateral oophorectomy and tubal ligation. 
  • All physical, occupational and rehab requests, consultations and progress notes.
  • All laboratory, histology, cytology, pathology and radiology records, results and reports.
  • All pharmacy/prescription records.


Qualified Participants May Receive:

Qualified participants may be compensated up to $2,675 for time and travel.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.