Efficacy and Safety of Snail Slime and Natural Extracts for Healing in Diabetic Foot Ulcers

Study Overview
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Brief Summary
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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: To evaluate the efficacy of the use of a formulation of snail slime Helix aspersa Müller and natural extracts (MU001) for the curative treatment of ulcer wonds in diabetic foot with respect to the standard of care, by means the application of patchs that containing the formulation in a treatment period of until 60 days. To determine the safety of the use of a formulation of snail slime Helix aspersa Müller and natural extracts (MU001) in diabetic individuals in a treatment period of until 60 days.

Detailed Description
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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.

Official Title
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Clinical Trial Phase I-II of Efficacy and Safety of Snail Slime and Natural Extracts for Healing in Diabetic Foot Ulcers

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Drug: MU001 patches (Investigational)
* Device: Conventional patches (Control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetes type 2 Unilateral ulcers Grade 1 or grade 2 Wagner ulcers. Without infection (except onychomycosis) Network family, hygiene, adherence and compliance appropiated Exclusion Criteria: Bilateral ulcers Medical conditions with high risk (cancer, allergies) Consum of abuse drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MU001 patches (Investigational)<br>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. | Drug: MU001 patches (Investigational)<br>* Patches containing snail slime, calendula extract and propolis extract<br>* Other names: MU001 patches;|
| Experimental: Conventional patches (Control)<br>Conventional patches approved for diabetic foot ulcers more standard of care. Two or three application for week. Treatment until 60 days. | Device: Conventional patches (Control)<br>* Patches containing conventional formulations in medical devices for ulcers (hydrocolloids, activated charcoal silver, alginate, carboxymethylcellulose or hydrogel).<br>* Other names: Conventional patches for diabetic foot ulcers;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of healing until 60 days or less | Incidence of healing measured with Wagner ulcer classification | 60 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |