Trial to Compare the Efficacy of elástic bandage 3M Coban™ 2 Lite against the Unna Boot in Patients with Leg Ulcers
- Conditions
- Injury and InjuryEdemaVaricose veins of the lower limbs with ulcerC23.888.277I83.0
- Registration Number
- RBR-3y78y4
- Lead Sponsor
- Escola de Enfermagem da Universidade Federal de MInas Gerais
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Male or female, aged 18 years or older; Ability to walk, either independently or with the aid of a walker; Active venous leg ulceration. If multiple eligible ulcers are present in the same leg, a single ulcer of the study leg that is up 2cm apart from any other ulcer should be selected. If eligible ulcers are on both legs, the investigator will determine which ulcer to choose as the indexed ulcer; Ulcer size between 5 cm2 and 200 cm2; Ulcer present for major 4 weeks and minor 52 weeks at the time of the screening visit; Visible edema in the leg with the selected ulcer; ABI up 0.8 and minor 1.3. ABI assessment performed within the 3 months prior to enrolment is acceptable; Provided written informed consent, including permission to take photographs of the study leg, including the wound; Ability to understand the study procedures and to complete the questionnaires; Women of childbearing potential should be sexually inactive or should use one of the following acceptable contraceptive methods (and continue to use it for at least 30 days after the end of the study; Stable hormonal contraceptive for at least 3 months prior to the study;Barrier method (preservative or diaphragm) with spermicide for at least 7 days prior to the screening visit; IUD placed at least 3 months prior to the study.
Women that are not of childbearing potential should be either surgically sterile (surgical bilateral tubal ligation at least 6 months prior to the study, hysterectomy or bilateral oophorectomy at least 3 months prior to the study), or be post-menopausal for over 2 years.
Severe arterial occlusive disease; Decompensated heart failure (New York Heart Association {NYHA} Class IV); Severe deep vein thrombosis (phlegmasia cerulea dolens) and other conditions contraindicated according to established guidelines and local procedures; Known hypersensitivity to any of the component materials, including isocyanates and synthetic rubber adhesives; Suspected clinical infection of the ulcer or any other systemic infection (requiring antibiotics); Planned or expected surgery for the ulcer during the 12 weeks following inclusion; Hospital stay planned for the 12 weeks following inclusion; Suspected or confirmed cancerous ulceration; Participation in any other prospective study interfering with this study; Any medical condition, which according to investigator’s clinical judgement, disqualifies the subject from enrollment into the study. Diabetic subjects are eligible if they are considered clinically under control or well-controlled; Autoimmune disease with use of systemic corticosteroids for more than 1 month (patients with auto-immune disease without use of systemic corticosteroids can be included). History of noncompliance to therapies; Severe impairment of the lymphatic system with severe deformation of the leg; Cardiomyopathy - diagnosis at screening; Dialytic chronic renal failure; Pregnancy;
Undergoing radiotherapy and chemotherapy.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in ankle edema from baseline to week three between the two treatment groups.<br>
- Secondary Outcome Measures
Name Time Method