[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04198454":3,"trial-entities:NCT04198454":75,"trial-summary:NCT04198454":79},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":43,"secondary_outcomes":47,"sex":48,"minimum_age":49,"maximum_age":17,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":55,"locations":58,"central_contacts":68,"overall_officials":69,"references":73,"see_also_links":74},"NCT04198454","STU00211239","Compression and CO2 Laser for Leg Wounds","Randomized, Investigator-blinded Study of Compression in Wound Healing With and Without Fractional Ablative CO2 Laser After Excisions on the Lower Extremity (CHIME+)","ENROLLING_BY_INVITATION","2028-06","2026-05","2026-07-01","2020-02-17","Northwestern University","OTHER",false,"The purpose of this study is to determine the efficacy and safety of compression bandaging with fractional ablative carbon dioxide laser (FACL) compared to compression and standard dressings alone for healing of post-operative wounds of the leg.\n\nThis is a randomized, SMART design, clinical trial. Approximately 80 participants will be randomized to initially receive compression bandages or standard wound dressings after surgery on the lower leg. After 4 weeks, the group assigned to compression bandages will be further randomized to either continue with the compression bandages only or continue with the compression bandages and also receive (FACL). The study is designed as an 6-month study. This study was a pilot study designed to determine feasibility of these procedure.\n\nSubjects currently living in the Chicago metropolitan area and meet inclusion\u002Fexclusion criteria will be considered for enrollment.",null,[19],"Wound Healing",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},80,"ESTIMATED",[29,34,38],{"type":14,"name":30,"description":31,"armGroupLabels":32},"Compression bandages","Class I (20-30 mmHg) compression bandages or stocking",[30,33],"Compression bandages with FACL",{"type":14,"name":35,"description":36,"armGroupLabels":37},"Standard wound dressings","Wound dressings alone consisting of gauze and skin tape to cover the wound",[35],{"type":39,"name":40,"description":41,"armGroupLabels":42},"DEVICE","Fractional ablative carbon dioxide laser","Participant will have laser applied to their wound bed.",[33],[44],{"measure":45,"timeFrame":46},"Mean change wound size as determined by measurements","Baseline to 6 months",[],"ALL","18 Years",true,{"inclusion":52,"exclusion":53,"raw_text":54},[],[],"Inclusion Criteria:Patients will be identified through the clinic where their skin is to be treated by excisional surgery on the lower leg. Those considered for enrollment must also meet the following criteria:\n\n1. \\>18 years of age\n2. Wound size of at least 1 cm in width\n3. Cutaneous excision of the lower leg\n4. Surgeon elected repair of healing by secondary intention\n5. Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study\n\nExclusion Criteria:\n\n1. Current smoker\n2. Uncontrolled diabetes mellitus\n3. Uncontrolled hypothyroidism\n4. Severe renal impairment or hypoalbuminemia\n5. Chronic lymphedema\n6. Severe venous insufficiency (large varicose veins, atrophie blanche)\n7. Arterial insufficiency (ABI \\\u003C 0.8)\n8. Rubber or rubber accelerator allergy\n9. Prior radiation to the surgical site\n10. History or evidence of a clinically significant medical or psychiatric disorder, condition or disease that in the opinion of the treating physician would pose a risk or interfere with evaluation or completion of the study\n11. Subject un willing to sign an IRB approved consent form\n12. Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible",[56,57],"ADULT","OLDER_ADULT",[59],{"facility":60,"city":61,"state":62,"zip":63,"country":64,"geoPoint":65},"Northwestern University Department of Dermatology","Chicago","Illinois","60611","United States",{"lat":66,"lon":67},41.85003,-87.65005,[],[70],{"name":71,"affiliation":13,"role":72},"Murad Alam, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":76,"biomarkers":78},[77],"Wound healed",[],{"nct_id":4,"found":50,"summary":80,"prompt_version":88},{"design":81,"status":82,"heading":6,"summary":83,"follow_up":81,"word_count":84,"commitments":85,"compensation":86,"drugs_mentioned":87},"Not specified.","completed","{\n   \"Compression and CO2 Laser for Leg Wounds\",\n   \"This study is looking at how well compression bandages and a fractional ablative carbon dioxide laser (FACL) help heal wounds on the lower leg after surgery. It compares this treatment to using compression bandages with standard wound dressings. You might be able to join if you are over 18, have a leg wound at least 1 cm wide from surgery, and your surgeon plans for the wound to heal on its own. The main goal is to see how much the wound size changes over 6 months. The study status is currently unclear, and it plans to include about 80 participants.\",\n  \"design\": \"This is a randomized study, meaning you would be assigned to a treatment group by chance. It's designed as a pilot study to see if these procedures are practical.\",\n  \"commitments\": \"You would initially receive either compression bandages or standard wound dressings after surgery. If you receive compression bandages, after 4 weeks you might be further assigned to continue with only compression bandages or to also receive laser treatment. The study lasts for 6 months.\",\n  \"compensation\": \"Not stated in the trial record.\",\n  \"follow_up\": \"Your wound size will be measured from the beginning of the study up to 6 months.\",\n}",209,"Not specified in the trial record.","Not stated in the trial record.",[30,35,40],"v2"]