Clinical trial NCT03166423: Efficacy and Safety of Snail Slime and Natural Extracts for Healing in Diabetic Foot Ulcers
Official title: Clinical Trial Phase I-II of Efficacy and Safety of Snail Slime and Natural Extracts for Healing in Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Diabetic Foot Ulcer
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2017-05-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Incidence rate of healing until 60 days or less
timeFrame: 60 days
Secondary outcomes:
measure: Time to healing until 60 days or less
timeFrame: 60 days
measure: Incidence of treatment-emergent adverse events (Safety and Tolerability) of a formulation of snail slime and natural extracts in healthy skin
timeFrame: 3 days
measure: Incidence of treatment-emergent adverse events (Safety and Tolerability) of a formulation of snail slime and natural extracts in ulcer wounds in diabetics foot
timeFrame: 60 days
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Dirección de salud San Bernardo
city: Santiago
country: Chile
facility: Dirección de Salud El Bosque
city: Santiago
country: Chile
facility: Dirección de salud Independencia
city: Santiago
country: Chile
facility: Dirección de salud San Miguel
Study officials:
affiliation: University of Chile
name: Luis A. Quiñones Sepúlveda, Dr.
role: PRINCIPAL_INVESTIGATOR
References: