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

University of Chile

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Diabetic Foot Ulcer

Treatments: Drug: MU001 patches (Investigational); Device: Conventional patches (Control)

Study type: Interventional

Funder types: Other

Identifiers

NCT03166423

CQF-EC-002-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

MU001 patches (Investigational)

Experimental group

Description:

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.

Treatment:

Drug: MU001 patches (Investigational)

Conventional patches (Control)

Experimental group

Description:

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

Treatment:

Device: Conventional patches (Control)