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

• ClinicalTrials.gov Identifier: NCT03166423
• Recruitment Status: Unknown
• First Posted: May 25, 2017
• Last Update Posted: May 30, 2017
• Sponsor: University of Chile
• Information provided by (Responsible Party): Luis Quiñones Sepulveda, University of Chile

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetic Foot Ulcer	Drug: MU001 patches (Investigational); Device: Conventional patches (Control)	Phase 1; Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Trial Phase I-II of Efficacy and Safety of Snail Slime and Natural Extracts for Healing in Diabetic Foot Ulcers
• Actual Study Start Date: November 12, 2015
• Estimated Primary Completion Date: June 1, 2017
• Estimated Study Completion Date: July 1, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: MU001 patches (Investigational); Patches containing snail slime, calendula extract and propolis extract; Other Name: MU001 patches
Experimental: Conventional patches (Control); 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); Patches containing conventional formulations in medical devices for ulcers (hydrocolloids, activated charcoal silver, alginate, carboxymethylcellulose or hydrogel).; Other Name: Conventional patches for diabetic foot ulcers

Outcome Measures

Primary Outcome Measures :

1. Incidence rate of healing until 60 days or less [ Time Frame: 60 days ]
   Incidence of healing measured with Wagner ulcer classification

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Chile

Dirección de salud San Bernardo

Santiago, Chile, 111111

Dirección de Salud El Bosque

Santiago, Chile, 8030009

Dirección de salud Independencia

Santiago, Chile, 8380359

Dirección de salud San Miguel

Santiago, Chile, 8930120

Sponsors and Collaborators

University of Chile

Investigators

• Principal Investigator: Luis A. Quiñones Sepúlveda, Dr.; University of Chile

More Information

• Responsible Party: Luis Quiñones Sepulveda, Dr., University of Chile
• ClinicalTrials.gov Identifier: NCT03166423
• Other Study ID Numbers: CQF-EC-002-14
• First Posted: May 25, 2017
• Last Update Posted: May 30, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetic Foot; Foot Ulcer; Ulcer; Pathologic Processes; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases