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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03166423
Recruitment Status : Unknown
Verified May 2017 by Luis Quiñones Sepulveda, University of Chile.
Recruitment status was:  Active, not recruiting
First Posted : May 25, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Luis Quiñones Sepulveda, University of Chile

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Drug: MU001 patches (Investigational) Device: Conventional patches (Control) Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial Phase I-II of Efficacy and Safety of Snail Slime and Natural Extracts for Healing in Diabetic Foot Ulcers
Actual Study Start Date : November 12, 2015
Estimated Primary Completion Date : June 1, 2017
Estimated Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

Drug: MU001 patches (Investigational)
Patches containing snail slime, calendula extract and propolis extract
Other Name: MU001 patches

Experimental: Conventional patches (Control)
Conventional patches approved for diabetic foot ulcers more standard of care. Two or three application for week. Treatment until 60 days.
Device: Conventional patches (Control)
Patches containing conventional formulations in medical devices for ulcers (hydrocolloids, activated charcoal silver, alginate, carboxymethylcellulose or hydrogel).
Other Name: Conventional patches for diabetic foot ulcers




Primary Outcome Measures :
  1. Incidence rate of healing until 60 days or less [ Time Frame: 60 days ]
    Incidence of healing measured with Wagner ulcer classification


Secondary Outcome Measures :
  1. Time to healing until 60 days or less [ Time Frame: 60 days ]
    Time to healing measured with Wagner ulcer classification

  2. Incidence of treatment-emergent adverse events (Safety and Tolerability) of a formulation of snail slime and natural extracts in healthy skin [ Time Frame: 3 days ]
    Numbers and types of adverse events in healthy skin of subjects treated with investigational formulation (MU001)

  3. Incidence of treatment-emergent adverse events (Safety and Tolerability) of a formulation of snail slime and natural extracts in ulcer wounds in diabetics foot [ Time Frame: 60 days ]
    Numbers and types of adverse events in ulcers of subjects treated with investigational formulation (MU001)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03166423


Locations
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Chile
Dirección de salud San Bernardo
Santiago, Chile, 111111
Dirección de Salud El Bosque
Santiago, Chile, 8030009
Dirección de salud Independencia
Santiago, Chile, 8380359
Dirección de salud San Miguel
Santiago, Chile, 8930120
Sponsors and Collaborators
University of Chile
Investigators
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Principal Investigator: Luis A. Quiñones Sepúlveda, Dr. University of Chile
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Responsible Party: Luis Quiñones Sepulveda, Dr., University of Chile
ClinicalTrials.gov Identifier: NCT03166423    
Other Study ID Numbers: CQF-EC-002-14
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases