Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of VLU (FREEDOM) (FREEDOM)
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|ClinicalTrials.gov Identifier: NCT04613687|
Recruitment Status : Not yet recruiting
First Posted : November 3, 2020
Last Update Posted : November 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Venous Leg Ulcer||Device: Compression bandage||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, multi centre, non-comparative study|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of Venous or Mixed Predominantly Venous Leg Ulcers|
|Estimated Study Start Date :||October 30, 2020|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||September 30, 2021|
Device: Compression bandage
Compression bandage URGO BD001 for the management of venous leg ulcers with ABPI (Ankle Brachial Pressure Index) ≥ 0.8, venous
- Relative reduction in wound surface area (percent) [ Time Frame: 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
- Complete ulcer closure: [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 6 weeks or last assessment ]
Evolution of the peri-wound skin at each visit according to the following parameters:
- Altered: Erythematous and/or squamous (irritated dermatitis/eczema), maceration, other
- Safety analysis [ Time Frame: 6 weeks or last assessment ]Nature and number of adverse event related to the use of the testing compression system (serious/ non-serious)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04613687
|Contact: Batot Géraldine, PhD||+33 3 80 44 28 firstname.lastname@example.org|
|Contact: Tacca Olivier, PhD||+33 3 80 44 74 email@example.com|
|Principal Investigator:||Senet Patricia, MD||Vascular dermatologist, APHP, Paris, France|
|Principal Investigator:||Dissemond Joachim, MD||Clinic for dermatology, Essen- Germany|