Evaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer

June 28, 2018 updated by: Catalysis SL

Evaluation of Nutritional Supplement DIAMEL® Combined With Insulin in Diabetic Foot Ulcer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cuba
    • Havana
      • Vedado, Havana, Cuba, 10400
        • National Institute of Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DIAMEL
Study group that receives the active product.
Dietary supplement: DIAMEL
Diamel is administered 6 capsules a day divided into three doses that are ingested before each meal.
Placebo Comparator: Placebo
Control group receiving double-blind placebo.
Dietary supplement: Placebo
Placebo is administered 6 capsules a day divided into three doses that are ingested before each meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of healing
Time Frame: 1 year
The most important outcome measure is to evaluate the early healing of diabetic foot ulcers with the shape and improvements of the foot ulcers.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: 1 year
Glucose measures with blood test
1 year
Lipidic control
Time Frame: 1 year
Triglycerides and cholesterol levels with blood test
1 year
Body mass control
Time Frame: 1 year
Body mass test
1 year
Renal function control
Time Frame: 1 year
Renal function measures by Creatinine Clearance Blood Test
1 year
Insulin control
Time Frame: 1 year
Insulin levels measured by the Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) and insulin sensitivity (%S), as percentages of a normal reference population
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalysis SL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2014

Primary Completion (Actual)

November 12, 2017

Study Completion (Actual)

November 30, 2017

Study Registration Dates

First Submitted

June 15, 2018

First Submitted That Met QC Criteria

June 28, 2018

First Posted (Actual)

July 11, 2018

Study Record Updates

Last Update Posted (Actual)

July 11, 2018

Last Update Submitted That Met QC Criteria

June 28, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIAMEL-DIABETICFOOT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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