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

NCT03166423 | Unknown Phase 1

• 1 other identifier: CQF-EC-002-14
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 4

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. 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. 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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Incidence rate of healing until 60 days or less

  Incidence of healing measured with Wagner ulcer classification

  60 days

Secondary Outcomes (3)

• Time to healing until 60 days or less

  60 days

• Incidence of treatment-emergent adverse events (Safety and Tolerability) of a formulation of snail slime and natural extracts in healthy skin

  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

  60 days

Study Arms (2)

MU001 patches (Investigational)

EXPERIMENTAL

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)

Conventional patches (Control)

EXPERIMENTAL

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)

Interventions

MU001 patches (Investigational) DRUG

Patches containing snail slime, calendula extract and propolis extract

Also known as: MU001 patches

MU001 patches (Investigational)

Conventional patches (Control) DEVICE

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

Also known as: Conventional patches for diabetic foot ulcers

Conventional patches (Control)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes type 2
• Unilateral ulcers
• Grade 1 or grade 2 Wagner ulcers.
• Without infection (except onychomycosis)
• Network family, hygiene, adherence and compliance appropiated

You may not qualify if:

• Bilateral ulcers
• Medical conditions with high risk (cancer, allergies)
• Consum of abuse drugs

Sponsors & Collaborators

• University of Chile: lead

Study Sites (4)

Dirección de salud San Bernardo

Santiago, 111111, Chile

Location

Dirección de Salud El Bosque

Santiago, 8030009, Chile

Location

Dirección de salud Independencia

Santiago, 8380359, Chile

Location

Dirección de salud San Miguel

Santiago, 8930120, Chile

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Luis A. Quiñones Sepúlveda, Dr.

  University of Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: May 25, 2017
• Study Start: November 12, 2015
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: May 30, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (4)