Clinical Trial Phase I-II of Efficacy and Safety of Snail Slime and Natural Extracts for Healing in Diabetic Foot Ulcers
Overview
- Phase
- Phase 1
- Intervention
- MU001 patches (Investigational)
- Conditions
- Diabetic Foot Ulcer
- Sponsor
- University of Chile
- Enrollment
- 90
- Locations
- 4
- Primary Endpoint
- Incidence rate of healing until 60 days or less
- Last Updated
- 8 years ago
Overview
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:
- 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.
- 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.
Investigators
Luis Quiñones Sepulveda
Dr.
University of Chile
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
Arms & Interventions
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.
Intervention: MU001 patches (Investigational)
Conventional patches (Control)
Conventional patches approved for diabetic foot ulcers more standard of care. Two or three application for week. Treatment until 60 days.
Intervention: Conventional patches (Control)
Outcomes
Primary Outcomes
Incidence rate of healing until 60 days or less
Time Frame: 60 days
Incidence of healing measured with Wagner ulcer classification
Secondary Outcomes
- 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 ulcer wounds in diabetics foot(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)