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| Name | Class |
|---|---|
| Hospital de Cruces | OTHER |
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It has been shown that diabetic patients present a significant increase in markers related to oxidative stress, which increases even more in those with diabetic foot ulcers and gradually depending on the severity of the injury and inversely to the mechanisms of physiological antioxidants of these patients. Therefore, these patients present a situation of oxidative stress (high lipid peroxidation), with an insufficient level of antioxidant enzymes to reverse this state, which leads to maintenance of the inflammatory situation and therefore the chronification of the ulcer. Investigators' aim in this study is to measure the benefits that the application of the product with antioxidant capacity REOXCARE can bring, together with the usual good clinical wound care guidelines and other essential therapeutic activities, such as pressure relief in the area of the ulcers.
The frequency in the appearance of diabetic foot lesions is extremely high; it is estimated that around 15% of people with diabetes will present some compromise at the level of the foot during the evolution of the disease. The high rate of recurrence of these lesions and their high mortality rate make this pathology an important health problem with high health, economic and social repercussions. Diabetic foot injury is defined as any infection, ulceration, and/or destruction of the deep tissues of the foot associated with neurological, vascular, and metabolic disorders (sustained hyperglycemia) in the lower limbs of people with diabetes. Between 40% and 70% of lower-limb amputations occur in the diabetic population, and in up to 85% of cases, the triggering factor is ulcer, associated with infection and gangrene. The incidence of a new episode after an amputation is around 50% 5 years later.
It has been shown that diabetic patients present a significant increase in markers related to oxidative stress, which increases even more in those with diabetic foot ulcers and gradually depending on the severity of the injury and inversely to the mechanisms of physiological antioxidants of these patients. Therefore, these patients present a situation of oxidative stress (high lipid peroxidation), with an insufficient level of antioxidant enzymes to reverse this state, which leads to maintenance of the inflammatory situation and therefore the chronification of the ulcer. Investigators' aim in this study is to measure the benefits that the application of the product with antioxidant capacity REOXCARE can bring, together with the usual good clinical wound care guidelines and other essential therapeutic activities, such as pressure relief in the area of the ulcers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antioxidant dressing (active product) | Experimental | Wound bed debridement, Antioxidant dressing (active product) application in the wound bed, covered with secondary dressing. Device: Reoxcare® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reoxcare antioxidant dressing | Device | After wound cleaning activities, wound bed debridement if necessary and elimination of hyperkeratotic edges, wounds are treated with Reoxcare as primary dressing and the approppriate secondary dressing for adequate exudates management |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Granulation tissue in the wound bed | The percentage of granulation tissue in the wound bed is estimated by the clinicians in each week of Reoxcare treatment, At baseline and every week | At baseline, after 1 week, after 2 week, after 3 week, after 4 weeks, after 5 weeks, after 6 weeks, after 7 weeks and after 8 week |
| Changes in wound size | The difference in wound area between first and last dressing Reoxcare treatment | At baseline, after 1 week, after 2 week, after 3 week, after 4 weeks, after 5 weeks, after 6 weeks, after 7 weeks and after 8 week |
| Measure | Description | Time Frame |
|---|---|---|
| Number of completely healed wounds | Number of wounds closed with respect to total number of wounds at each frame time | At baseline, after 1 week, after 2 week, after 3 week, after 4 weeks, after 5 weeks, after 6 weeks, after 7 weeks and after 8 week |
| Time to removal of non-viable tissue from wound bed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andima Basterretxea, MD | Hospital Universitario de Cruces | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Cruces | Barakaldo | Bizkaia | 48903 | Spain | ||
| Histocell |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26140672 | Background | Castro B, Palomares T, Azcoitia I, Bastida F, del Olmo M, Soldevilla JJ, Alonso-Varona A. Development and preclinical evaluation of a new galactomannan-based dressing with antioxidant properties for wound healing. Histol Histopathol. 2015 Dec;30(12):1499-512. doi: 10.14670/HH-11-646. Epub 2015 Jul 3. | |
| 29244974 | Background |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D016523 | Foot Ulcer |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Percentage of wounds with non-viable tissue in the wound bed at each frame time |
| At baseline, after 1 week, after 2 week, after 3 week, after 4 weeks, after 5 weeks, after 6 weeks, after 7 weeks and after 8 week |
| Derio |
| Vizcaya |
| 48160 |
| Spain |
| Castro B, Bastida FD, Segovia T, Lopez Casanova P, Soldevilla JJ, Verdu-Soriano J. The use of an antioxidant dressing on hard-to-heal wounds: a multicentre, prospective case series. J Wound Care. 2017 Dec 2;26(12):742-750. doi: 10.12968/jowc.2017.26.12.742. |
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003929 | Diabetic Neuropathies |