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OpenTrials
Completed

NCT Number: NCT03583593

Evaluation of 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.

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Key information

Conditions

Diabetic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Institute of Endocrinology

Vedado, La Habana, 10400, Cuba

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diamel

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 11, 2018
Registry last updated
Jul 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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