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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-12

Study Completion Date

2017-07-01

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:

1. 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.
2. 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.

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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.

Conditions

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Diabetic Foot Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MU001 patches (Investigational)

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.

Group Type EXPERIMENTAL

MU001 patches (Investigational)

Intervention Type DRUG

Patches containing snail slime, calendula extract and propolis extract

Conventional patches (Control)

Conventional patches approved for diabetic foot ulcers more standard of care. Two or three application for week. Treatment until 60 days.

Group Type EXPERIMENTAL

Conventional patches (Control)

Intervention Type DEVICE

Patches containing conventional formulations in medical devices for ulcers (hydrocolloids, activated charcoal silver, alginate, carboxymethylcellulose or hydrogel).

Interventions

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MU001 patches (Investigational)

Patches containing snail slime, calendula extract and propolis extract

Intervention Type DRUG

Conventional patches (Control)

Patches containing conventional formulations in medical devices for ulcers (hydrocolloids, activated charcoal silver, alginate, carboxymethylcellulose or hydrogel).

Intervention Type DEVICE

Other Intervention Names

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MU001 patches Conventional patches for diabetic foot ulcers

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