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

Phase 1

• Conditions: Diabetic Foot Ulcer
• Interventions: Drug: MU001 patches (Investigational); Device: Conventional patches (Control)

• Registration Number: NCT03166423
• Lead Sponsor: University of Chile

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-11-12
• Study First Submitted: 2017-04-24
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-23
• Last Update Submitted: 2017-05-24
• Study First Posted: 2017-05-25
• Last Update Posted: 2017-05-30
• Primary Completion: 2017-06-01
• Study Completion: 2017-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MU001 patches (Investigational)	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.
Conventional patches (Control)	Conventional patches (Control)	Conventional patches approved for diabetic foot ulcers more standard of care. Two or three application for week. Treatment until 60 days.

Primary Outcome Measures

Name	Time	Method
Incidence rate of healing until 60 days or less	60 days	Incidence of healing measured with Wagner ulcer classification

Secondary Outcome Measures

Name	Time	Method
Time to healing until 60 days or less	60 days	Time to healing measured with Wagner ulcer classification
Incidence of treatment-emergent adverse events (Safety and Tolerability) of a formulation of snail slime and natural extracts in ulcer wounds in diabetics foot	60 days	Numbers and types of adverse events in ulcers of subjects treated with investigational formulation (MU001)
Incidence of treatment-emergent adverse events (Safety and Tolerability) of a formulation of snail slime and natural extracts in healthy skin	3 days	Numbers and types of adverse events in healthy skin of subjects treated with investigational formulation (MU001)

Trial Locations

Locations (4)

Dirección de Salud El Bosque; 🇨🇱 Santiago, Chile

Dirección de salud San Bernardo; 🇨🇱 Santiago, Chile

Dirección de salud Independencia; 🇨🇱 Santiago, Chile

Dirección de salud San Miguel; 🇨🇱 Santiago, Chile