Diabetic Foot Ulcer
Conditions
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.
Interventions
DRUGMU001 patches (Investigational)
Patches containing snail slime, calendula extract and propolis extract
DEVICEConventional patches (Control)
Patches containing conventional formulations in medical devices for ulcers (hydrocolloids, activated charcoal silver, alginate, carboxymethylcellulose or hydrogel).
Sponsors
University of Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of healing until 60 days or less | 60 days | Incidence of healing measured with Wagner ulcer classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to healing until 60 days or less | 60 days | Time to healing measured with Wagner ulcer classification |
| Incidence of treatment-emergent adverse events (Safety and Tolerability) of a formulation of snail slime and natural extracts in healthy skin | 3 days | Numbers and types of adverse events in healthy skin of subjects treated with investigational formulation (MU001) |
| 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 | Numbers and types of adverse events in ulcers of subjects treated with investigational formulation (MU001) |
Countries
Chile
Outcome results
None listed