Diabetic Foot UlcerPhase 1/2NCT03166423
Efficacy and Safety of Snail Slime and Natural Extracts for Healing in Diabetic Foot Ulcers
A Phase 1/2 study testing MU001 patches (Investigational) in people with Diabetic Foot Ulcer, run by University of Chile at 4 sites in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- MU001 patches (Investigational)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesChile
- Study dates
- 12 Nov 2015to 1 Jul 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes type 2
- Unilateral ulcers
- Grade 1 or grade 2 Wagner ulcers.
- Without infection (except onychomycosis)
- Network family, hygiene, adherence and compliance appropiated
Who cannot join
- Bilateral ulcers
- Medical conditions with high risk (cancer, allergies)
- Consum of abuse drugs
Trial locations and contacts
4 sites in 1 country.
Chile4 sites
Dirección de salud San Bernardo
Santiago, 111111
Dirección de Salud El Bosque
Santiago, 8030009
Dirección de salud Independencia
Santiago, 8380359
Dirección de salud San Miguel
Santiago, 8930120
About this study
Official title: Clinical Trial Phase I-II of Efficacy and Safety of Snail Slime and Natural Extracts for Healing in Diabetic Foot Ulcers
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.
Read the 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
- Being tested
- MU001 patches (Investigational), Conventional patches (Control)
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MU001 patches (Investigational)Drug
Also called MU001 patches
Patches containing snail slime, calendula extract and propolis extract
Conventional patches (Control)Device
Also called Conventional patches for diabetic foot ulcers
Patches containing conventional formulations in medical devices for ulcers (hydrocolloids, activated charcoal silver, alginate, carboxymethylcellulose or hydrogel).
| Study group | Role | What they receive |
|---|---|---|
| MU001 patches (Investigational) | Experimental | 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. Receives: Drug: MU001 patches (Investigational) |
| Conventional patches (Control) | Experimental | Conventional patches approved for diabetic foot ulcers more standard of care. Two or three application for week. Treatment until 60 days. Receives: Device: Conventional patches (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of healing until 60 days or less
Incidence of healing measured with Wagner ulcer classification
Measured: 60 days
Secondary outcomes (3)
Time to healing until 60 days or less
Time to healing measured with Wagner ulcer classification
Measured: 60 days
Incidence of treatment-emergent adverse events (Safety and Tolerability) of a formulation of snail slime and natural extracts in healthy skin
Numbers and types of adverse events in healthy skin of subjects treated with investigational formulation (MU001)
Measured: 3 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
Numbers and types of adverse events in ulcers of subjects treated with investigational formulation (MU001)
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start12 Nov 2015
- Primary completion1 Jun 2017 (estimated)
- Study completion1 Jul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Quiñones Sepulveda, University of Chile
- Investigators
- Luis A. Quiñones Sepúlveda, Dr., Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166423
- Sponsor's protocol ID
- CQF-EC-002-14
- Status last verified
- May 2017
- First submitted
- 24 Apr 2017
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Phase I-II of Efficacy and Safety of Snail Slime and Natural Extracts for Healing in Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT03166423
- Acronym / sponsor ID
- CQF-EC-002-14
- Conditions
- Diabetic Foot Ulcer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 12 Nov 2015 (actual)
- Primary completion
- 1 Jun 2017 (estimated)
- Study completion
- 1 Jul 2017 (estimated)
- First posted
- 25 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MU001 patches (Investigational) | Experimental | Drug: 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. |
| Conventional patches (Control) | Experimental | Device: Conventional patches (Control)Conventional patches approved for diabetic foot ulcers more standard of care. Two or three application for week. Treatment until 60 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diabetes type 2
- Unilateral ulcers
- Grade 1 or grade 2 Wagner ulcers.
- Without infection (except onychomycosis)
- Network family, hygiene, adherence and compliance appropiated
Key exclusion criteria (3 listed)
- Bilateral ulcers
- Medical conditions with high risk (cancer, allergies)
- Consum of abuse drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MU001 patches (Investigational)Also: MU001 patchesPatches containing snail slime, calendula extract and propolis extract | Drug | MU001 patches (Investigational) |
| Conventional patches (Control)Also: Conventional patches for diabetic foot ulcersPatches containing conventional formulations in medical devices for ulcers (hydrocolloids, activated charcoal silver, alginate, carboxymethylcellulose or hydrogel). | Device | Conventional patches (Control) |
Primary outcome
Incidence rate of healing until 60 days or less
Time frame: 60 days
Incidence of healing measured with Wagner ulcer classification
3 secondary outcomes
Time to healing until 60 days or less
Time frame: 60 days
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot Ulcer
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Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis A. Quiñones Sepúlveda, Dr. principal investigator
University of Chile
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MU001 patches (Investigational) in people with Diabetic Foot Ulcer, run by University of Chile at 4 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of healing until 60 days or less (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.