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| Name | Class |
|---|---|
| Vitebsk Regional Clinical Hospital | OTHER_GOV |
| Unitary Enterprise UNITEHPROM BSU | UNKNOWN |
| The 10th Minsk City Clinical Hospital | UNKNOWN |
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The purpose of this study is to estimate efficiency, tolerance, safety of "Foscelantan, medicinal plate 4.0x5.0 cm in package No. 1" among adult patients who have purulent-inflammatory processes of the skin and soft tissues due to the neuropathic form of diabetic foot syndrome or chronic venous insufficiency, phase I-II of the wound process.
Diabetes takes the third place in the World in terms of its medical and social significance. Diabetes is often complicated with such urulent-inflammatory processe as diabetic foot syndrome. Urulent-inflammatory processes treatment takes a long time and medications due to microcirculation disorders, metabolic disorders, progressive hypoxia and a number of other factors. A moist wound environment, conducive to the natural process of wound cleansing (autolysis), regeneration of damaged tissue, and reduction of pain, irreversible sorption of excess exudate and toxic components and easy removal of the drug from the surface of the wound without additional trauma or damage are yhe main conditions of successful wound healing.Wound dressings made of fibrous polysaccharides modyfied with drugs meet these requirements. Foscelantan has prolonged antimicrobial, analgesic and reparative action, has the ability to transform on the wound surface into an amorphous gel-like mass, irreversibly bind wound detritus and pathological exudate, and provide optimal conditions for the process of wound healing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with the neuropathic form. Treatment with Foscelantan | Experimental | A prospective, parallel, single-blind clinical study using stratified randomization of the effectiveness, tolerability and safety of the drug "Foscelantan, medicinal plate 4.0×5.0 cm in package No. 1" produced by UNITEHPROM BSU, Republic of Belarusin adult patients with purulent-inflammatory processes of the skin and soft tissues due to the neuropathic form of diabetic foot syndrome, phase I-II wound process. All patients will receive systemic traditional therapy for the underlying and concomitant diseases. |
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| Patients with the neuropathic form. Treatment with Povidone-iodine | Active Comparator | A prospective, parallel, single-blind clinical study using stratified randomization of the effectiveness, tolerability and safety of the drug Povidone-iodine produced by BelAseptika JSC, in adult patients with purulent-inflammatory processes of the skin and soft tissues due to the neuropathic form of diabetic foot syndrome, phase I-II wound process. All patients will receive systemic traditional therapy for the underlying and concomitant diseases. |
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| Patients with chronic venous insufficiency. Treatment with Foscelantan | Experimental | A prospective, parallel, single-blind clinical study using stratified randomization of the effectiveness, tolerability and safety of the drug "Foscelantan, medicinal plate 4.0×5.0 cm in package No. 1" produced by UNITEHPROM BSU, Republic of Belarus in adult patients with purulent inflammatory processes of the skin and soft tissues due to chronic venous insufficiency," phase I-II of the wound process. All patients will receive systemic traditional therapy for the underlying and concomitant diseases. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foscelantan | Drug | "Foscelantan, medicinal plate 4.0x5.0 cm in package No. 1" produced by UNITEHPROM BSU, Republic of Belarus |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with trophic ulcers cured | Number of patients cured | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| percentage reduction in the non-epithelialized area of the wound surface in relation to the initial one | Additionally, the percentage reduction in the non-epithelialized area of the wound surface relative to the original will be calculated, determined by digital non-contact planimetry during dressing changes. This indicator will be assessed using a digital camera and image analysis software | 15 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eugen Grinyuk, Ph.D., Associate professor | Contact | +375 17 209-52-54 | hryniuk@bsu.by | |
| Pavel Bychkovsky, Ph.D., Associate Professor | Contact | +375 17 209-58-40 | bychkovsky@tut.by |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 10th CITY CLINICAL HOSPITAL | Minsk | Minsk City | 220096 | Belarus |
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| Patients with chronic venous insufficiency. Treatment with Povidone-iodine | Active Comparator | A prospective, parallel, single-blind clinical study using stratified randomization of the effectiveness, tolerability and safety of the drug Povidone-iodine produced by BelAseptika JSC, in adult patients with purulent-inflammatory processes of the skin and soft tissues due to chronic venous insufficiency", phase I-II of the wound process . All patients will receive systemic traditional therapy for the underlying and concomitant diseases. |
|
| Povidon-iodine | Drug | Povidone-iodine solution 100 mg/ml produced by BelAseptika CJSC, Republic of Belarus |
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| Health care institution Vitebsk Regional Clinical Hospital | Vitebsk | Vitebsk Oblast | 210037 | Belarus |
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