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Evaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer

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ClinicalTrials.gov Identifier: NCT03583593
Recruitment Status : Completed
First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Catalysis SL

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Diabetic Foot Diabetes Mellitus, Type 2 Dietary Supplement: DIAMEL Dietary Supplement: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: It is a double blind study, that is, neither the researcher nor the patient knows if he takes placebo or the active tablet.
Primary Purpose: Supportive Care
Official Title: Evaluation of Nutritional Supplement DIAMEL® Combined With Insulin in Diabetic Foot Ulcer
Actual Study Start Date : May 23, 2014
Actual Primary Completion Date : November 12, 2017
Actual Study Completion Date : November 30, 2017

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Glycemic control [ Time Frame: 1 year ]
    Glucose measures with blood test

  2. Lipidic control [ Time Frame: 1 year ]
    Triglycerides and cholesterol levels with blood test

  3. Body mass control [ Time Frame: 1 year ]
    Body mass test

  4. Renal function control [ Time Frame: 1 year ]
    Renal function measures by Creatinine Clearance Blood Test

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT03583593


Locations
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Cuba
National Institute of Endocrinology
Vedado, Havana, Cuba, 10400
Sponsors and Collaborators
Catalysis SL
More Information
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Responsible Party: Catalysis SL
ClinicalTrials.gov Identifier: NCT03583593    
Other Study ID Numbers: DIAMEL-DIABETICFOOT
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Catalysis SL:
Diabetes
Insulin
Diabetic Foot
Nutritional supplement
Diamel
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetes Mellitus, Type 2
Ulcer
Pathologic Processes
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetic Neuropathies
Foot Diseases