Leg Ulcers
Conditions
Keywords
Mixed leg ulcers, Quality of life questionnaire, light compression system
Brief summary
Evaluation of the efficacy (wound epithelialization and time to closure) and safety (emergence and nature of adverse event) of a lite compression system versus a tubular bandage in the local treatment of mixed leg ulcers: prospective multicenter, randomized controlled, open-label french clinical study
Detailed description
This is a prospective, randomized, controlled, open-label, multicenter clinical trial conducted in patients with a mixed (non-ischemic) leg ulcer of stage C6 / C6r of the CEAP classification. This study is carried out in around 50 French investigational centers. A total of 210 patients meeting the eligibility criteria will be included. The patients will be followed for 16 weeks and a total of 6 clinical evaluations will be carried out by the investigating centers. A planimetric survey of the studied leg ulcers is carried out during the initial assessment of the wound (Day 0) and at each assessment provided for in the protocol (Week 2, Week 4, Week 8 and Week 12). A QoL is carried out at D0 and end of the study for each patient included in the protocol.
Interventions
DEVICETreatment with light compression systeme during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)
Treatment with light compression system during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)
DEVICELight compression system of the mixed leg ulcer stage C6 / C6r of the CEAP classification
Etiological treatment of mixed leg ulcer stage C6 / C6r of the CEAP classification
Sponsors
Laboratoires URGO
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomization 2:1 (light compression system vs tubular bandage)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patient (≥ 18 years old), having given free, informed and written consent * Patient affiliated to a social security scheme * Patient agreeing to wear the study compression system daily * Patient with an ankle circumference between 18 and 25 cm * Target wound: stage C6 / C6r mixed leg ulcer of the CEAP classification with a 0.6≤ ABPI≤0.8 and TABP≥ 50 mm Hg and arterial echo Doppler confirming the mixed nature of the leg ulcer * Target wound with an area between 2 and 20 cm2 * Target wound with age of ≤18 months Criteria exclusion: * Patient with a systemic infection not controlled by appropriate antibiotic therapy * Patient having presented in the 3 months preceding his inclusion, a deep vein thrombosis * Severe arterial pathology, including an Ankle Blood Pressure Index (ABPI) less than 3 months old \<0.6 * Patient bedridden or spending less than an hour per day standing * Clinically infected target wound * Cancerized target wound
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete closure of the Venous Leg Ulcer (VLU) | 16-week treament period | Description: Complete closure of the leg ulcer is defined by 100% re-epithelialization of the mixed Leg Ulcer (MLU) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to complete closure of the Venous Leg Ulcer (VLU) | 16-week treament period | Description: Time to complete closure of the Mixed Leg Ulcer (MLU) is defined as the time from inclusion to the date of complete closure |
| Safety analysis | 16-week treament period | Nature and number of adverse event related to the use of the studied light compression system and tubular bandage (serious/ non-serious and emergent) |
Countries
France
Contacts
Primary ContactAnne AnS SAUVADET, Dr, PhD
Backup ContactOlivier OlT TACCA, Dr, PhD
Outcome results
None listed