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

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03166423
• Other study ID #: CQF-EC-002-14
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: April 24, 2017
• Last updated: May 24, 2017
• Start date: November 12, 2015
• Est. completion date: July 1, 2017

Study information

• Verified date: May 2017
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: July 1, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Drug:
• MU001 patches (Investigational)
Patches containing snail slime, calendula extract and propolis extract

Device:
• Conventional patches (Control)
Patches containing conventional formulations in medical devices for ulcers (hydrocolloids, activated charcoal silver, alginate, carboxymethylcellulose or hydrogel).

Locations

Country	Name	City	State
Chile	Dirección de Salud El Bosque	Santiago
Chile	Dirección de salud Independencia	Santiago
Chile	Dirección de salud San Bernardo	Santiago
Chile	Dirección de salud San Miguel	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of healing until 60 days or less	Incidence of healing measured with Wagner ulcer classification	60 days
Secondary	Time to healing until 60 days or less	Time to healing measured with Wagner ulcer classification	60 days
Secondary	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
Secondary	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