Injury and Injury
Conditions
Interventions
138 participants where 69 in each group:
2 groups.
Group 1: Application of the compression system Unna Flexi-Dress boot every 7 days (+/- 48h)
Group 2: Application of the 3M Coban 2 Two Layer Compress
Device
Sponsors
Escola de Enfermagem da Universidade Federal de MInas Gerais
Escola de Enfermagem da Universidade Federal de MInas Gerais
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in ankle edema from baseline to week three between the two treatment groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Average percent change in calf edema from baseline to weeks 3, 6, and 12 between the two treatment groups. (Because the edema will be measured at each visit, the data from each visit will be analyzed as well. This applies to all other measurements taken at each visit). ;Average percent change in ankle edema from baseline to weeks 6 and 12 between the two treatment groups. ;Average pain score in the leg of the indexed ulcer (visual numeric scale) after 3, 6 and 12 weeks. ;• Average reduction of the pain score in the leg of the indexed ulcer between the baseline and week 3, 6 and 12, according to the visual numeric scale (1-10). ;Volume of exudate in the ulcer evaluated after 12 weeks (1 = very little, 2 = little, 3 = moderate, 4 = large). ;Average percent reduction of ulcer size area between the baseline and weeks 3, 6 and 12. ;Percent reduction = ((Initial Area – Area at Week x)/(Initial Area)) x 100%. ;Average percent bandage wear over the bandage height at application. Each bandage wear episode is defined as up to 7 days or until the bandage is changed. ;Mean score of FLQA-W (Freiburg Life Quality Assessment) for each dimension (physical symptoms, treatment, daily life, psychological well-being, satisfaction and social life) at randomization, week 6 and 12. ;Change in mean score of FLQA-W for each dimension at week 6 and 12 compared to randomization visit. ;Frequency of adverse events over 12 weeks for each treatment group. ;Percentage of patients with complete healing of the ulcer (complete reepithelialization and median time for complete healing). | — |
Countries
Brazil
Contacts
Public ContactCristiane Franco
3M do Brasil Ltda
Outcome results
None listed