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The primary objective is to evaluate the efficacy and safety of the use of a formulation of snail slime and natural extracts, for the curative treatment of ulcer wonds in diabetic foot.
The secondary objetives:
Clinical Study of phase I-II, controlled, simple blind (in relation with biostatistical analysis), randomized, of formulation that containing snail slime Helix aspersa Müller (Cryptophalus aspersus), natural calendula extract, propolis and excipients (MU001).
The formulation in study MU001 wil be added to the standard of care for healing in diabetic foot indicated. The period of recruitment estimated will be 4 month and the follow-up of the patients will be of until 60 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MU001 patches (Investigational) | Experimental | Patches MU001 (snail slime, calendula extract and propolis extract) more standard of care. Two or three application for week. Treatment until 60 days. Patches MU001 (snail slime, calendula extract and propolis extract) on health zone. Three days of treatment. |
|
| Conventional patches (Control) | Experimental | Conventional patches approved for diabetic foot ulcers more standard of care. Two or three application for week. Treatment until 60 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MU001 patches (Investigational) | Drug | Patches containing snail slime, calendula extract and propolis extract |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of healing until 60 days or less | Incidence of healing measured with Wagner ulcer classification | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to healing until 60 days or less | Time to healing measured with Wagner ulcer classification | 60 days |
| Incidence of treatment-emergent adverse events (Safety and Tolerability) of a formulation of snail slime and natural extracts in healthy skin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis A. Quiñones Sepúlveda, Dr. | University of Chile | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dirección de salud San Bernardo | Santiago | 111111 | Chile | |||
| Dirección de Salud El Bosque |
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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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| Conventional patches (Control) | Device | Patches containing conventional formulations in medical devices for ulcers (hydrocolloids, activated charcoal silver, alginate, carboxymethylcellulose or hydrogel). |
|
|
Numbers and types of adverse events in healthy skin of subjects treated with investigational formulation (MU001)
| 3 days |
| Incidence of treatment-emergent adverse events (Safety and Tolerability) of a formulation of snail slime and natural extracts in ulcer wounds in diabetics foot | Numbers and types of adverse events in ulcers of subjects treated with investigational formulation (MU001) | 60 days |
| Santiago |
| 8030009 |
| Chile |
| Dirección de salud Independencia | Santiago | 8380359 | Chile |
| Dirección de salud San Miguel | Santiago | 8930120 | Chile |
| 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 |