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The main purpose of this trial is to demonstrate that the new dressing is more effective than the current dressing in the local treatment of chronic foot ulcers in diabetic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| URGO 310 3113 dressing - new | Experimental | flexible, conformable, non-adhesive and non-occlusive lipido-colloid matrix that does not adhere to the wound. |
|
| URGO 310 3113 dressing | Placebo Comparator | flexible, conformable, non-adhesive and non-occlusive lipido-colloid matrix that does not adhere to the wound. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urgo 310 3113 | Device | URGO 310 3113 dressing may be changed every 2 to 4 days, and left in place for up to 7 days, depending on the level of exudate and the wound condition |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of complete wound closure |
| Measure | Description | Time Frame |
|---|---|---|
| Time to complete wound closure | ||
| Change in wound surface area |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacques MARTINI, MD | Contact | 00 33 5 61 32 32 89 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recruiting | Toulouse | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33481840 | Derived | Maunoury F, Oury A, Fortin S, Thomassin L, Bohbot S; Explorer Study. Cost-effectiveness of TLC-NOSF dressings versus neutral dressings for the treatment of diabetic foot ulcers in France. PLoS One. 2021 Jan 22;16(1):e0245652. doi: 10.1371/journal.pone.0245652. eCollection 2021. | |
| 29275068 | Derived | Edmonds M, Lazaro-Martinez JL, Alfayate-Garcia JM, Martini J, Petit JM, Rayman G, Lobmann R, Uccioli L, Sauvadet A, Bohbot S, Kerihuel JC, Piaggesi A. Sucrose octasulfate dressing versus control dressing in patients with neuroischaemic diabetic foot ulcers (Explorer): an international, multicentre, double-blind, randomised, controlled trial. Lancet Diabetes Endocrinol. 2018 Mar;6(3):186-196. doi: 10.1016/S2213-8587(17)30438-2. Epub 2017 Dec 20. |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| Placebo URGO 310 3113 dressing | Device |
|
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |