Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
80 participants
INTERVENTIONAL
2020-02-17
2025-06-30
Brief Summary
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This 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.
Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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Compression bandages
Class I (20-30 mmHg) compression bandages or stocking. This is considered a standard measure in the recovery of lower extremity wounds and often recommended.
Compression bandages
Class I (20-30 mmHg) compression bandages or stocking
Standard wound dressings
Wound dressings alone consisting of gauze and skin tape to cover the wound.
Standard wound dressings
Wound dressings alone consisting of gauze and skin tape to cover the wound
Compression bandages with FACL
Class I compression (20-30 mmHg) bandage or stocking with FACL.
Compression bandages
Class I (20-30 mmHg) compression bandages or stocking
Fractional ablative carbon dioxide laser
Participant will have laser applied to their wound bed.
Interventions
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Compression bandages
Class I (20-30 mmHg) compression bandages or stocking
Standard wound dressings
Wound dressings alone consisting of gauze and skin tape to cover the wound
Fractional ablative carbon dioxide laser
Participant will have laser applied to their wound bed.
Eligibility Criteria
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Inclusion Criteria
2. Wound size of at least 1 cm in width
3. Cutaneous excision of the lower leg
4. Surgeon elected repair of healing by secondary intention
5. Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
Exclusion Criteria
2. Uncontrolled diabetes mellitus
3. Uncontrolled hypothyroidism
4. Severe renal impairment or hypoalbuminemia
5. Chronic lymphedema
6. Severe venous insufficiency (large varicose veins, atrophie blanche)
7. Arterial insufficiency (ABI \< 0.8)
8. Rubber or rubber accelerator allergy
9. Prior radiation to the surgical site
10. 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
11. Subject un willing to sign an IRB approved consent form
12. 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
18 Years
ALL
Yes
Sponsors
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Northwestern University
OTHER
Responsible Party
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Murad Alam
Professor of Dermatology
Principal Investigators
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Murad Alam, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern University Department of Dermatology
Chicago, Illinois, United States
Countries
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Other Identifiers
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STU00211239
Identifier Type: -
Identifier Source: org_study_id
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