Venous Leg Ulcer
Conditions
Brief summary
The aim of this study is to evaluate the therapeutic efficacy and the safety of the new compression system URGO BD001 in the management of venous or mixed predominantly venous leg ulcers. The therapeutic efficacy will be the reduction in wound surface area during a six weeks study treatment period.
Detailed description
The compression bandage URGO BD001 is indicated for the management of venous leg ulcers with ABPI (Ankle Brachial Pressure Index) ≥ 0.8, venous oedema and lymphedema justifying strong compression. The pressure applied with the compression system URGO BD001 help to improve venous return and to reduce venous oedema. The expected clinical benefits from the compression system URGO BD001 in patient with a VLU are to increase healing rate and time to healing, and to improve patient quality of life.
Interventions
DEVICECompression bandage
Compression bandage URGO BD001 for the management of venous leg ulcers with ABPI (Ankle Brachial Pressure Index) ≥ 0.8, venous
Sponsors
Laboratoires URGO
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multi centre, non-comparative study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient affected by VLU or mixed ulcer of predominantly venous origin (ankle brachial pressure index (ABPI) ≥ 0.8 and ≤ 1.3), * Wound in granulation phase (granulation tissue ≥50%), * Wound at least 3 cm away from any edge of another wound, * VLU between 2 and 20 cm2 in surface area, * VLU duration between 1 to 24 months.
Exclusion criteria
* Patient under guardianship or protection of vulnerable adult, * Patient with known allergy to any components of the tested compression system, * Patient with a severe illness that might lead to premature discontinuation of the trial before the end of treatment period, * Patient with progressive neoplastic lesions treated by radiotherapy, chemotherapy, hormone therapy or immune suppressor, * Patient with non-controlled systemic infection by a suitable antibiotic therapy, * Patient who had a deep vein thrombosis within 3 months prior to the inclusion, * Patient with a lymphedema due to lymphatic obstruction, * Diabetic patient with advanced diagnosed microangiopathy, * Bedridden patient, or those spending less than one hour per day on their feet, * Wound covered partially or totally with necrotic tissue, * Clinically infected wound, * Wound requiring surgical treatment or for which a surgery is scheduled during the study period, * Cancerous lesions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative reduction in wound surface area (percent) | 6 weeks | Evolution between D0 and the 6 weeks treatment period with the URGO BD001 compression system: Relative reduction in wound surface area (%) = \[(SW6 - SD0)/SD0\] × 100 SD0: Wound surface area at D0 SW6: Wound surface area at Week 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete ulcer closure: | 6 weeks or last assessment | The percent (%) of patients with complete ulcer closure (100% re-epithelialization) after 6 weeks or at the latest treatment period |
| Venous oedema | 6 weeks or last assessment | Oedema reduction from baseline (D0) and last assessment by measuring the limb circumference (in cm), using a tape: * Ankle circumference at the reference point B (smallest perimeter of the leg, 3 cm above medial malleolus, * Calf circumference at the reference point C (maximum perimeter of the calf). |
| Patient quality of Life (EuroQoL 5D-5L) | 6 weeks or last assessment | EuroQoL 5D-5L between baseline and at last visit. The questionnaire essentially consists of a descriptive system including 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a visual analogue scale (EQ VAS) from the worst health you can imagine (0) to the best health you can imagine (100). |
| Evolution of the periwound skin | 6 weeks or last assessment | Evolution of the peri-wound skin at each visit according to the following parameters: * Healthy * Altered: Erythematous and/or squamous (irritated dermatitis/eczema), maceration, other |
| Safety analysis | 6 weeks or last assessment | Nature and number of adverse event related to the use of the testing compression system (serious/ non-serious) |
Contacts
Primary ContactBatot Géraldine, PhD
Backup ContactTacca Olivier, PhD
Outcome results
None listed