Evaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-23

Study Completion Date

2017-11-30

Brief Summary

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Diabetic foot syndrome is one of the most frequent complications in type 2 diabetic patients. The present work is carried out with the objective of evaluating the use of DIamel combined with insulin in diabetic foot ulcers. Method. Phase II clinical trial. A study group was created that receives the active product and another control group that receives a placebo. Double-blind study with a monthly follow-up for the first 6 months and then quarterly until the end of 1 year. Complementary tests are performed every 6 months to evaluate metabolic, lipid and renal function control.

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Detailed Description

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Conditions

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Diabetic Foot Ulcer Diabetic Foot Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

It is a double blind study, that is, neither the researcher nor the patient knows if he takes placebo or the active tablet.

Study Groups

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DIAMEL

Study group that receives the active product.

Group Type EXPERIMENTAL

DIAMEL

Intervention Type DIETARY_SUPPLEMENT

Diamel is administered 6 capsules a day divided into three doses that are ingested before each meal.

Placebo

Control group receiving double-blind placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo is administered 6 capsules a day divided into three doses that are ingested before each meal.

Interventions

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DIAMEL

Diamel is administered 6 capsules a day divided into three doses that are ingested before each meal.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo is administered 6 capsules a day divided into three doses that are ingested before each meal.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (% B) and insulin sensitivity (% S), as percentages of a normal reference population

Exclusion Criteria

* Manifestation of hypersensitivity to any component of the product
* Uncooperative patients
* Severe infection
* Debilitating diseases
* Steroid treatment
* Pregnancy

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No