NCT03166423

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

Clinical Trial Phase I-II of Efficacy and Safety of Snail Slime and Natural Extracts for Healing in Diabetic Foot Ulcers

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University of Chile · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DRUG	MU001 patches (Investigational)	Patches containing snail slime, calendula extract and propolis extract
DEVICE	Conventional patches (Control)	Patches containing conventional formulations in medical devices for ulcers (hydrocolloids, activated charcoal silver, alginate, carboxymethylcellulose or hydrogel).

Timeline

• Start date: 2015-11-12
• Primary completion: 2017-06-01
• Completion: 2017-07-01
• First posted: 2017-05-25
• Last updated: 2017-05-30

Locations

4 sites across 1 country: Chile